Alcohol Abuse or DependenceAOANCT03848000
Examination of Whether an Exercise Programme Reduces Alcohol Consumption Among Alcohol-Dependent Adults
A study testing Exercise Programme in people with Alcohol Abuse or Dependence and Alcohol Use Disorder, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
This study is composed of two phases. Phase 1 will determine baseline demographic characteristics of participants, currently drinking harmful amounts of alcohol, who would be interested in an alternative treatment option to reduce alcohol consumption. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Abuse or Dependence, Alcohol Use Disorder
- What is being tested?
- Exercise Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Dec 2018to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years old
- AUDIT score of ≥ 8
- In the opinion of the referring physician, is capable of performing moderate/high-intensity exercise
- Agrees to their GP being informed of their participation
- Able and willing to provide written informed consent and complete the study questionnaires
Who cannot join
- Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine.
- Have anorexia, bipolar disorder or severe (unstable) psychosis disorder which may preclude active participation.
- In the opinion of the referring physician, is physically incapable or likely to be incapable of undertaking an exercise programme.
- Pregnant or planning pregnancy within the first 3 months after randomisation.
- Currently participating in >90 minutes/week of structured moderate-intensity exercise, such as jogging, cycling or swimming (not including walking).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Feasibility Study to Examine the Efficacy of a Combined Group-based Exercise and Educational Programme on Alcohol Consumption, Mental Health and Physical Health Among Alcohol-Dependent Adults
This study is composed of two phases. Phase 1 will determine baseline demographic characteristics of participants, currently drinking harmful amounts of alcohol, who would be interested in an alternative treatment option to reduce alcohol consumption. Once baseline data is collected, participants will then be informed that the intervention is an exercise programme and those interested will be offered participation in Phase 2: a two-arm randomised controlled study. If eligible, participants will be randomly assigned to either: 1) a 12 week combined exercise programme and NHS standard care group, or 2) 12 weeks of NHS (National Health Service) standard care only group.
The aims are to study the feasibility of conducting a randomised controlled trial in this cohort and to determine the effectiveness of the exercise programme to reduce alcohol consumption, improve physical and mental health among people drinking harmful amounts of alcohol, compared to standard NHS care. Assessment visits, measuring alcohol consumption, mental health and physical health, will be conducted at baseline, and at Weeks 13, 24, 36 and 48 since commencement of the intervention period. Focus groups will take place during the 2nd and 12th week of the exercise programme where qualitative feedback on the exercise programme will be collected.
Read the detailed description
Alcohol-dependent patients often experience depression, anxiety and stress, and it is thought that these may be important factors associated with increased alcohol consumption. Regular moderate/high-intensity exercise has been repeatedly reported to reduce depression, anxiety and stress, with regular exercise also shown to be effective in achieving a pleasurable state, improving coping mechanisms and increasing self-confidence among substance-dependent patients. Additionally, exercise-based therapy may be perceived by alcohol-dependent patients as a less stigmatising therapy option than traditional medication and counselling treatments.
While a small number of studies suggest that regular exercise is effective in improving fitness levels among alcohol-dependent adults, there is a lack of consensus regarding the efficacy of regular exercise to reduce alcohol consumption. Of a recent systematic review, 3 of the 5 studies reported that regular exercise reduced alcohol consumption and craving of alcohol. However, while a recent meta-analysis didn't find evidence of exercise significantly reducing alcohol consumption, the three small studies that were assessed all found that exercise training induced some reductions in alcohol consumption; suggesting that regular exercise may be effective in reducing alcohol consumption.
This study is composed of two phases. Phase 1 will determine the characteristics of participants currently drinking harmful amounts of alcohol who would be interested in being offered a new, alternative treatment to reduce alcohol consumption. During their NHS standard care (Phase 1; Visit 1), potential participants will be asked by either a member of the study team, or by the standard care team, if they "would you be willing to consider taking part in a study to look at new ways of treating people addicted to alcohol?'. While no specific details of the intervention will be provided at this time, participants who are interested will be given the participant information sheet (Phase 1) which will include further details of the study. A member of the study team will contact potential participants and, if they are happy to take part, another visit (Phase 1; Visit 2) will be arranged for patients to complete the demographic questionnaires. Visit 2 will take place at one of the study sites and written informed consent will be taken before the patient completes the study questionnaires which will determine characteristics including age, gender, ethnicity, marital status, educational background, employment status, smoking status, number of previous attempts to reduce alcohol consumption, family history of addiction, other drug intake, alcohol consumption (7 Day Drinking Diary), dependence of alcohol consumption (Alcohol Use Disorders Identification Test (AUDIT) questionnaire), severity of alcohol dependence (SADQ), alcohol craving (Penn Alcohol Craving Scale), impact of alcohol consumption on daily life (Alcohol Problems Questionnaire), depression (Patient Health Questionnaire (PHQ-9)), anxiety (Generalised Anxiety Disorder (GAD-7) questionnaire) and current physical activity levels (short-form International Physical Activity Questionnaire (IPAQ)).
Participants who complete Phase 1 of the study will be invited to participate in Phase 2 of the study on the same day (i.e. at the end of Visit 2 of Phase 1 of the study). Interested participants will be provided with full information regarding the nature of the randomised controlled trial - i.e. that this is an exercise-based intervention study - and will be given a separate participant information sheet (Phase 2). A member of the study team will contact potential participants and, if they are happy to participate, the screening visit will be arranged. Participants who decline enrolment into the exercise-based randomized controlled trial will be asked if they are willing to take part in a short telephone interview to enquire about reasons for not wanting to partake in the study. Both participants who agree, and do not agree, to take part in the short telephone interview will be offered NHS standard care. The telephone interviews will be audio-recorded, with participants consent, and transcribed verbatim. This will allow us to identify the characteristics of participants who are interested in exercise. Baseline demographics and characteristics of participants offered the intervention, who consent to provision of data, will be recorded and compared to the demographics of those who decline to participate in the intervention.
Participants who agree to participate in Phase 2 of the study will undergo screening for eligibility. Written informed consent for Phase 2 of the study will be undertaken with a 2nd informed consent form. This visit will be conducted by a member of the study team at one of the NHS hospital sites and current medications and medical history will be recorded, as well as the Physical Activity Readiness Questionnaire (PARQ), to provide a screening measure of physical readiness for exercise. Only if the participant meets the inclusion/exclusion criteria will they be allowed to continue into the study. Participants who do not meet the inclusion/exclusion criteria will be informed that they are not eligible and will be offered NHS standard care. At the end of the screening visit, an accelerometer (Actigraph) will be provided to participants who will be asked to wear it for seven consecutive days in order to measure baseline physical activity levels.
Participants will return the accelerometer (from the screening visit) during the baseline testing visit and will complete the Alcohol Self-Efficacy Scale, Perceived Stress Scale and Short Form (SF-36) questionnaire, before having all physical health measurements (resting heart rate, resting blood pressure, stature, body mass, waist circumference, cardiorespiratory fitness) recorded. A venous blood sample will be collected to measure full blood count and liver enzyme biomarkers, while a finger-prick capillary blood sample will be collected to measure phosphatidylethanol (PEth); a marker of alcohol consumption.
Once the baseline testing visit is completed, participants will be randomly assigned to one of two groups: 1) a 12 week combined exercise (moderate/high-intensity) programme and NHS standard care group (n=48), or 2) 12 weeks of NHS standard care only group (n=48).
The exercise programme will take place in a local sports centre facility in East London, and will be delivered by qualified exercise coaches linked to West Ham United Football Club. Participants will be required to complete two sessions each week for 12 consecutive weeks, in addition to receiving NHS standard care consisting of counselling and support. Each session will begin with a 30 minute education talk (covering topics regarding the physical and mental health benefits of exercise and behaviour change) and will be followed by a 30-60 minute exercise session. Each exercise session will begin with a standard low-intensity 10 minute warm-up/stretch and end with a low-intensity 5 minute cool-down. The main body of the exercise session will utilise a combination of different exercise modalities, including pad-boxing, football and circuit training. The duration of exercise sessions will be gradually increased as follows: Weeks 1-2: 30 minutes; Weeks 3-4: 40 minutes; Weeks 5-6: 50 minutes; Weeks 7-12: 60 minutes. Recruitment of participants will be split into three separate intakes and each exercise group will consist of approximately 15 patients. Participants in the exercise programme will be invited to participate in focus groups on the 3rd session (week 2) and 24th session (week 12) of the exercise programme. The two focus groups will each last approximately 1 hour each and will be conducted by a member of the study team who is fully trained and experienced in undertaking focus group discussions. During the week 2 focus group, the topics for discussion will be the participant's knowledge and beliefs regarding exercise, their barriers to being physically active, their attitude and motivation to being physically active, their expectations of the exercise programme, and what challenges they foresee during the programme. During the week 12 focus group, the topics for discussion will be the participant's experience of the programme, the potential benefits of the programme and what impact it has had on their alcohol consumption, physical health and quality of life. The focus groups will be audio-recorded, with patients consent, and fully transcribed verbatim, anonymized and coded. A thematic analysis will be undertaken to identify recurring and salient themes that are conceptually and inherently significant.
Participants who are randomised to the NHS standard care only group will not receive the exercise programme but will be provided with NHS standard care at one of the NHS study sites. Participants will be provided with the name of their alcohol key worker and will receive a weekly one-to-one counselling alcohol addiction session lasting 1 hour where support and behavioural interventions will be offered, in line with current NHS practice. Drug therapy will be offered if indicated in line with standard therapy.
At the completion of the 12 week intervention period, participants in both the combined exercise programme and NHS standard care group, and the NHS standard care only group will complete 4 follow-up testing visits: at Week 13, Week 24, Week 36 and Week 48 after commencement of the study. These follow-up visits will coincide with the participants routine, clinically-necessary hospital visits. All follow-up visits will be conducted by a member of the study team at one of the NHS hospital sites. At the start of each of the follow-up visits, a member of the study team will verify that the participant is still happy to continue with their participation in the study. Participants will complete the alcohol consumption, physical health, mental health and physical activity questionnaires (the same as the baseline testing visit) at each follow-up testing visit. The finger-prick capillary blood sample, collected to measure phosphatidylethanol (PEth); a marker of alcohol consumption, will only be collected at the Week 24 follow-up visit. At the end of the Week 13 and Week 48 visits, the participant will be given an accelerometer and asked to wear it for seven consecutive days in order to measure physical activity levels over the next week. A visit window of 2 weeks will be set for the Week 13 follow-up testing visit while a visit window of 4 weeks will be set for the Week 24, Week 36 and Week 48 follow-up testing visits to allow for missed or rescheduled appointments.
- Conditions
- Alcohol Abuse or Dependence, Alcohol Use Disorder
- Being tested
- Exercise Programme, NHS Standard Care
- Keywords
- Alcohol abuse, Exercise, Alcohol consumption, Depression, Anxiety
- Medical subject headings
- Alcoholism, Motor Activity, Alcohol Drinking, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgrammeOther
Two sessions per week for 12 consecutive weeks. 30 minute education talks covering topics regarding the physical and mental health benefits of exercise and behaviour change. The following 30-60 minute exercise sessions will utilise pad-boxing, football, body-weight training and circuit training.
NHS Standard CareBehavioural
Weekly one-to-one cognitive-behavioral counselling alcohol addiction support session lasting 1 hour. Drug therapy will be offered if indicated in line with standard therapy.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Programme and NHS Standard Care | Experimental | Exercise and NHS standard care. Receives: Other: Exercise Programme; Behavioral: NHS Standard Care |
| NHS Standard Care only | Active comparator | Alcohol addiction counselling. Receives: Behavioral: NHS Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in absolute total weekly alcohol consumption from baseline, at 13 weeks follow-up
The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)
Measured: Baseline visit and Week 13 follow-up visit
Change in absolute total weekly alcohol consumption from baseline, at 24 weeks follow-up
The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)
Measured: Baseline visit and Week 24 follow-up visit
Change in absolute total weekly alcohol consumption from baseline, at 36 weeks follow-up
The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)
Measured: Baseline visit and Week 36 follow-up visit
Change in absolute total weekly alcohol consumption from baseline, at 48 weeks follow-up
The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)
Measured: Baseline visit and Week 48 follow-up visit
Secondary outcomes (97)
Change in number of drinking days per week from baseline, at 13 weeks follow-up
The change in the number of drinking days per week will be quantified from a 7 day self-reported drinking diary
Measured: Baseline visit and Week 13 follow-up visit
Change in number of drinking days per week from baseline, at 24 weeks follow-up
The change in the number of drinking days per week will be quantified from a 7 day self-reported drinking diary
Measured: Baseline visit and Week 24 follow-up visit
Change in number of drinking days per week from baseline, at 36 weeks follow-up
The change in the number of drinking days per week will be quantified from a 7 day self-reported drinking diary
Measured: Baseline visit and Week 36 follow-up visit
Change in number of drinking days per week from baseline, at 48 weeks follow-up
The change in the number of drinking days per week will be quantified from a 7 day self-reported drinking diary
Measured: Baseline visit and Week 48 follow-up visit
Change in number of heavy drinking days per week from baseline, at 13 weeks follow-up
The change in the number of heavy drinking days per week will be quantified from a 7 day self-reported drinking diary
Measured: Baseline visit and Week 13 follow-up visit
Change in number of heavy drinking days per week from baseline, at 24 weeks follow-up
The change in the number of heavy drinking days per week will be quantified from a 7 day self-reported drinking diary
Measured: Baseline visit and Week 24 follow-up visit
Change in number of heavy drinking days per week from baseline, at 36 weeks follow-up
The change in the number of heavy drinking days per week will be quantified from a 7 day self-reported drinking diary
Measured: Baseline visit and Week 36 follow-up visit
Change in number of heavy drinking days per week from baseline, at 48 weeks follow-up
The change in the number of heavy drinking days per week will be quantified from a 7 day self-reported drinking diary
Measured: Baseline visit and Week 48 follow-up visit
Change in number of alcohol free days per week from baseline, at 13 weeks follow-up
The change in the number of alcohol free days per week will be quantified from a 7 day self-reported drinking diary
Measured: Baseline visit and Week 13 follow-up visit
Change in number of alcohol free days per week from baseline, at 24 weeks follow-up
The change in the number of alcohol free days per week will be quantified from a 7 day self-reported drinking diary
Measured: Baseline visit and Week 24 follow-up visit
Change in number of alcohol free days per week from baseline, at 36 weeks follow-up
The change in the number of alcohol free days per week will be quantified from a 7 day self-reported drinking diary
Measured: Baseline visit and Week 36 follow-up visit
Change in number of alcohol free days per week from baseline, at 48 weeks follow-up
The change in the number of alcohol free days per week will be quantified from a 7 day self-reported drinking diary
Measured: Baseline visit and Week 48 follow-up visit
Change in Alcohol Use Disorders Identification Test (AUDIT) score from baseline, at 13 weeks follow-up
The change in Alcohol Use Disorders Identification Test (AUDIT) score will be determined by the completion of a 10-item AUDIT questionnaire
Measured: Baseline visit and Week 13 follow-up visit
Change in Alcohol Use Disorders Identification Test (AUDIT) score from baseline, at 24 weeks follow-up
The change in Alcohol Use Disorders Identification Test (AUDIT) score will be determined by the completion of a 10-item AUDIT questionnaire
Measured: Baseline visit and Week 24 follow-up visit
Change in Alcohol Use Disorders Identification Test (AUDIT) score from baseline, at 36 weeks follow-up
The change in Alcohol Use Disorders Identification Test (AUDIT) score will be determined by the completion of a 10-item AUDIT questionnaire
Measured: Baseline visit and Week 36 follow-up visit
Change in Alcohol Use Disorders Identification Test (AUDIT) score from baseline, at 48 weeks follow-up
The change in Alcohol Use Disorders Identification Test (AUDIT) score will be determined by the completion of a 10-item AUDIT questionnaire
Measured: Baseline visit and Week 48 follow-up visit
Change in Severity of Alcohol Dependence Questionnaire (SADQ) score from baseline, at 13 weeks follow-up
The change in the Severity of Alcohol Dependence Questionnaire (SADQ) score will be determined by the completion of the 20-item SADQ questionnaire
Measured: Baseline visit and Week 13 follow-up visit
Change in Severity of Alcohol Dependence Questionnaire (SADQ) score from baseline, at 24 weeks follow-up
The change in the Severity of Alcohol Dependence Questionnaire (SADQ) score will be determined by the completion of the 20-item SADQ questionnaire
Measured: Baseline visit and Week 24 follow-up visit
Change in Severity of Alcohol Dependence Questionnaire (SADQ) score from baseline, at 36 weeks follow-up
The change in the Severity of Alcohol Dependence Questionnaire (SADQ) score will be determined by the completion of the 20-item SADQ questionnaire
Measured: Baseline visit and Week 36 follow-up visit
Change in Severity of Alcohol Dependence Questionnaire (SADQ) score from baseline, at 48 weeks follow-up
The change in the Severity of Alcohol Dependence Questionnaire (SADQ) score will be determined by the completion of the 20-item SADQ questionnaire
Measured: Baseline visit and Week 48 follow-up visit
Change in alcohol cravings from baseline, at 13 weeks follow-up
The change in alcohol cravings will be quantified by the completion of the 5-item Penn Alcohol Craving Scale questionnaire
Measured: Baseline visit and Week 13 follow-up visit
Change in alcohol cravings from baseline, at 24 weeks follow-up
The change in alcohol cravings will be quantified by the completion of the 5-item Penn Alcohol Craving Scale questionnaire
Measured: Baseline visit and Week 24 follow-up visit
Change in alcohol cravings from baseline, at 36 weeks follow-up
The change in alcohol cravings will be quantified by the completion of the 5-item Penn Alcohol Craving Scale questionnaire
Measured: Baseline visit and Week 36 follow-up visit
Change in alcohol cravings from baseline, at 48 weeks follow-up
The change in alcohol cravings will be quantified by the completion of the 5-item Penn Alcohol Craving Scale questionnaire
Measured: Baseline visit and Week 48 follow-up visit
Change in abstinence self-efficacy from baseline, at 13 weeks follow-up
The change in alcohol abstinence self-efficacy will be determined by the completion of the 40-item Alcohol Abstinence Self-Efficacy Scale questionnaire
Measured: Baseline visit and Week 13 follow-up visit
Change in abstinence self-efficacy from baseline, at 24 weeks follow-up
The change in alcohol abstinence self-efficacy will be determined by the completion of the 40-item Alcohol Abstinence Self-Efficacy Scale questionnaire
Measured: Baseline visit and Week 24 follow-up visit
Change in abstinence self-efficacy from baseline, at 36 weeks follow-up
The change in alcohol abstinence self-efficacy will be determined by the completion of the 40-item Alcohol Abstinence Self-Efficacy Scale questionnaire
Measured: Baseline visit and Week 36 follow-up visit
Change in abstinence self-efficacy from baseline, at 48 weeks follow-up
The change in alcohol abstinence self-efficacy will be determined by the completion of the 40-item Alcohol Abstinence Self-Efficacy Scale questionnaire
Measured: Baseline visit and Week 48 follow-up visit
Change in alcohol problems from baseline, at 13 weeks follow-up
The change in social problems caused by alcohol consumption will be determined by the completion of the 49-item Alcohol Problems questionnaire
Measured: Baseline visit and Week 13 follow-up visit
Change in alcohol problems from baseline, at 24 weeks follow-up
The change in social problems caused by alcohol consumption will be determined by the completion of the 49-item Alcohol Problems questionnaire
Measured: Baseline visit and Week 24 follow-up visit
Change in alcohol problems from baseline, at 36 weeks follow-up
The change in social problems caused by alcohol consumption will be determined by the completion of the 49-item Alcohol Problems questionnaire
Measured: Baseline visit and Week 36 follow-up visit
Change in alcohol problems from baseline, at 48 weeks follow-up
The change in social problems caused by alcohol consumption will be determined by the completion of the 49-item Alcohol Problems questionnaire
Measured: Baseline visit and Week 48 follow-up visit
Change in blood phosphatidylethanol (PEth) from baseline, at 24 weeks follow-up
Change in blood phosphatidylethanol (collected via finger-prick capillary blood test)
Measured: Baseline visit and Week 24 follow-up visit
Change in blood gamma glutamyl transferase from baseline, at 13 weeks follow-up
Change in the liver enzyme biomarker gamma glutamyl transferase (collected during venous blood collection)
Measured: Baseline visit and Week 13 follow-up visit
Change in blood gamma glutamyl transferase from baseline, at 24 weeks follow-up
Change in the liver enzyme biomarker gamma glutamyl transferase (collected during venous blood collection)
Measured: Baseline visit and Week 24 follow-up visit
Change in blood gamma glutamyl transferase from baseline, at 36 weeks follow-up
Change in the liver enzyme biomarker gamma glutamyl transferase (collected during venous blood collection)
Measured: Baseline visit and Week 36 follow-up visit
Change in blood gamma glutamyl transferase from baseline, at 48 weeks follow-up
Change in the liver enzyme biomarker gamma glutamyl transferase (collected during venous blood collection)
Measured: Baseline visit and Week 48 follow-up visit
Change in blood alanine aminotransferase from baseline, at 13 weeks follow-up
Change in the liver enzyme biomarker alanine aminotransferase (collected during venous blood collection)
Measured: Baseline visit and Week 13 follow-up visit
Change in blood alanine aminotransferase from baseline, at 24 weeks follow-up
Change in the liver enzyme biomarker alanine aminotransferase (collected during venous blood collection)
Measured: Baseline visit and Week 24 follow-up visit
Change in blood alanine aminotransferase from baseline, at 36 weeks follow-up
Change in the liver enzyme biomarker alanine aminotransferase (collected during venous blood collection)
Measured: Baseline visit and Week 36 follow-up visit
Change in blood alanine aminotransferase from baseline, at 48 weeks follow-up
Change in the liver enzyme biomarker alanine aminotransferase (collected during venous blood collection)
Measured: Baseline visit and Week 48 follow-up visit
Change in blood aspartate aminotransferase from baseline, at 13 weeks follow-up
Change in the liver enzyme biomarker aspartate aminotransferase (collected during venous blood collection)
Measured: Baseline visit and Week 13 follow-up visit
Change in blood aspartate aminotransferase from baseline, at 24 weeks follow-up
Change in the liver enzyme biomarker aspartate aminotransferase (collected during venous blood collection)
Measured: Baseline visit and Week 24 follow-up visit
Change in blood aspartate aminotransferase from baseline, at 36 weeks follow-up
Change in the liver enzyme biomarker aspartate aminotransferase (collected during venous blood collection)
Measured: Baseline visit and Week 36 follow-up visit
Change in blood aspartate aminotransferase from baseline, at 48 weeks follow-up
Change in the liver enzyme biomarker aspartate aminotransferase (collected during venous blood collection)
Measured: Baseline visit and Week 48 follow-up visit
Change in anxiety from baseline, at 13 weeks follow-up
Change in anxiety scores derived from the 7-item Generalised Anxiety Disorder (GAD-7) Questionnaire
Measured: Baseline visit and Week 13 follow-up visit
Change in anxiety from baseline, at 24 weeks follow-up
Change in anxiety scores derived from the 7-item Generalised Anxiety Disorder (GAD-7) Questionnaire
Measured: Baseline visit and Week 24 follow-up visit
Change in anxiety from baseline, at 36 weeks follow-up
Change in anxiety scores derived from the 7-item Generalised Anxiety Disorder (GAD-7) Questionnaire
Measured: Baseline visit and Week 36 follow-up visit
Change in anxiety from baseline, at 48 weeks follow-up
Change in anxiety scores derived from the 7-item Generalised Anxiety Disorder (GAD-7) Questionnaire
Measured: Baseline visit and Week 48 follow-up visit
Change in depression from baseline, at 13 weeks follow-up
Change in depression scores derived from the 9-item Patient Health Questionnaire (PHQ-9)
Measured: Baseline visit and Week 13 follow-up visit
Change in depression from baseline, at 24 weeks follow-up
Change in depression scores derived from the 9-item Patient Health Questionnaire (PHQ-9)
Measured: Baseline visit and Week 24 follow-up visit
Change in depression from baseline, at 36 weeks follow-up
Change in depression scores derived from the 9-item Patient Health Questionnaire (PHQ-9)
Measured: Baseline visit and Week 36 follow-up visit
Change in depression from baseline, at 48 weeks follow-up
Change in depression scores derived from the 9-item Patient Health Questionnaire (PHQ-9)
Measured: Baseline visit and Week 48 follow-up visit
Change in stress from baseline, at 13 weeks follow-up
Change in stress scores derived from the 10-item Perceived Stress Scale questionnaire
Measured: Baseline visit and Week 13 follow-up visit
Change in stress from baseline, at 24 weeks follow-up
Change in stress scores derived from the 10-item Perceived Stress Scale questionnaire
Measured: Baseline visit and Week 24 follow-up visit
Change in stress from baseline, at 36 weeks follow-up
Change in stress scores derived from the 10-item Perceived Stress Scale questionnaire
Measured: Baseline visit and Week 36 follow-up visit
Change in stress from baseline, at 48 weeks follow-up
Change in stress scores derived from the 10-item Perceived Stress Scale questionnaire
Measured: Baseline visit and Week 48 follow-up visit
Change in body weight from baseline, at 13 weeks follow-up
Change in body weight
Measured: Baseline visit and Week 13 follow-up visit
Change in body weight from baseline, at 24 weeks follow-up
Change in body weight
Measured: Baseline visit and Week 24 follow-up visit
Change in body weight from baseline, at 36 weeks follow-up
Change in body weight
Measured: Baseline visit and Week 36 follow-up visit
Change in body weight from baseline, at 48 weeks follow-up
Change in body weight
Measured: Baseline visit and Week 48 follow-up visit
Change in cardiorespiratory fitness from baseline, at 13 weeks follow-up
Change in cardiorespiratory fitness (Chester Step Test)
Measured: Baseline visit and Week 13 follow-up visit
Change in cardiorespiratory fitness from baseline, at 24 weeks follow-up
Change in cardiorespiratory fitness (Chester Step Test)
Measured: Baseline visit and Week 24 follow-up visit
Change in cardiorespiratory fitness from baseline, at 36 weeks follow-up
Change in cardiorespiratory fitness (Chester Step Test)
Measured: Baseline visit and Week 36 follow-up visit
Change in cardiorespiratory fitness from baseline, at 48 weeks follow-up
Change in cardiorespiratory fitness (Chester Step Test)
Measured: Baseline visit and Week 48 follow-up visit
Change in waist circumference from baseline, at 13 weeks follow-up
Change in waist circumference
Measured: Baseline visit and Week 13 follow-up visit
Change in waist circumference from baseline, at 24 weeks follow-up
Change in waist circumference
Measured: Baseline visit and Week 24 follow-up visit
Change in waist circumference from baseline, at 36 weeks follow-up
Change in waist circumference
Measured: Baseline visit and Week 36 follow-up visit
Change in waist circumference from baseline, at 48 weeks follow-up
Change in waist circumference
Measured: Baseline visit and Week 48 follow-up visit
Change in resting systolic and diastolic blood pressure from baseline, at 13 weeks follow-up
Change in resting systolic and diastolic blood pressure
Measured: Baseline visit and Week 13 follow-up visit
Change in resting systolic and diastolic blood pressure from baseline, at 24 weeks follow-up
Change in resting systolic and diastolic blood pressure
Measured: Baseline visit and Week 24 follow-up visit
Change in resting systolic and diastolic blood pressure from baseline, at 36 weeks follow-up
Change in resting systolic and diastolic blood pressure
Measured: Baseline visit and Week 36 follow-up visit
Change in resting systolic and diastolic blood pressure from baseline, at 48 weeks follow-up
Change in resting systolic and diastolic blood pressure
Measured: Baseline visit and Week 48 follow-up visit
Change in resting heart rate from baseline, at 13 weeks follow-up
Change in resting heart rate
Measured: Baseline visit and Week 13 follow-up visit
Change in resting heart rate from baseline, at 24 weeks follow-up
Change in resting heart rate
Measured: Baseline visit and Week 24 follow-up visit
Change in resting heart rate from baseline, at 36 weeks follow-up
Change in resting heart rate
Measured: Baseline visit and Week 36 follow-up visit
Change in resting heart rate from baseline, at 48 weeks follow-up
Change in resting heart rate
Measured: Baseline visit and Week 48 follow-up visit
Change in objective low-intensity physical activity levels from baseline, at 13 weeks follow-up
Change in low-intensity physical activity (minutes/day), as derived from an Actigraph accelerometer
Measured: Baseline visit and Week 13 follow-up visit
Change in objective moderate-intensity physical activity levels from baseline, at 13 weeks follow-up
Change in moderate-intensity physical activity (minutes/day), as derived from an Actigraph accelerometer
Measured: Baseline visit and Week 13 follow-up visit
Change in objective high-intensity physical activity levels from baseline, at 13 weeks follow-up
Change in high-intensity physical activity (minutes/day), as derived from an Actigraph accelerometer
Measured: Baseline visit and Week 13 follow-up visit
Change in objective very high-intensity physical activity levels from baseline, at 13 weeks follow-up
Change in very high-intensity physical activity (minutes/day), as derived from an Actigraph accelerometer
Measured: Baseline visit and Week 13 follow-up visit
Change in objective total physical activity expenditure from baseline, at 13 weeks follow-up
Change in total physical activity expenditure (kcal/day), as derived from an Actigraph accelerometer
Measured: Baseline visit and Week 13 follow-up visit
Change in objective sedentary time from baseline, at 13 weeks follow-up
Change in sedentary time (minutes/day), as derived from an Actigraph accelerometer
Measured: Baseline visit and Week 13 follow-up visit
Change in objective low-intensity physical activity levels from baseline, at 48 weeks follow-up
Change in low-intensity physical activity (minutes/day), as derived from an Actigraph accelerometer
Measured: Baseline visit and Week 48 follow-up visit
Change in objective moderate-intensity physical activity levels from baseline, at 48 weeks follow-up
Change in moderate-intensity physical activity (minutes/day), as derived from an Actigraph accelerometer
Measured: Baseline visit and Week 48 follow-up visit
Change in objective high-intensity physical activity levels from baseline, at 48 weeks follow-up
Change in high-intensity physical activity (minutes/day), as derived from an Actigraph accelerometer
Measured: Baseline visit and Week 48 follow-up visit
Change in objective very high-intensity physical activity levels from baseline, at 48 weeks follow-up
Change in very high-intensity physical activity (minutes/day), as derived from an Actigraph accelerometer
Measured: Baseline visit and Week 48 follow-up visit
Change in objective total physical activity expenditure from baseline, at 48 weeks follow-up
Change in total physical activity expenditure (kcal/day), as derived from an Actigraph accelerometer
Measured: Baseline visit and Week 48 follow-up visit
Change in objective sedentary time from baseline, at 48 weeks follow-up
Change in sedentary time (minutes/day), as derived from an Actigraph accelerometer
Measured: Baseline visit and Week 48 follow-up visit
Change in subjective physical activity levels from baseline, at 13 weeks follow-up
Change in vigorous-intensity and moderate-intensity physical activity levels, as determined by the International Physical Activity Questionnaire (IPAQ)
Measured: Baseline visit and Week 13 follow-up visit
Change in subjective physical activity levels from baseline, at 24 weeks follow-up
Change in vigorous-intensity and moderate-intensity physical activity levels, as determined by the International Physical Activity Questionnaire (IPAQ)
Measured: Baseline visit and Week 24 follow-up visit
Change in subjective physical activity levels from baseline, at 36 weeks follow-up
Change in vigorous-intensity and moderate-intensity physical activity levels, as determined by the International Physical Activity Questionnaire (IPAQ)
Measured: Baseline visit and Week 36 follow-up visit
Change in subjective physical activity levels from baseline, at 48 weeks follow-up
Change in vigorous-intensity and moderate-intensity physical activity levels, as determined by the International Physical Activity Questionnaire (IPAQ)
Measured: Baseline visit and Week 48 follow-up visit
Change in Quality of Life score from baseline, at 13 weeks follow-up
The change in quality of life score will be determined by the completion of the 36-item Short Form (SF-36) Questionnaire
Measured: Baseline visit and Week 13 follow-up visit
Change in Quality of Life score from baseline, at 24 weeks follow-up
The change in quality of life score will be determined by the completion of the 36-item Short Form (SF-36) Questionnaire
Measured: Baseline visit and Week 24 follow-up visit
Change in Quality of Life score from baseline, at 36 weeks follow-up
The change in quality of life score will be determined by the completion of the 36-item Short Form (SF-36) Questionnaire
Measured: Baseline visit and Week 36 follow-up visit
Change in Quality of Life score from baseline, at 48 weeks follow-up
The change in quality of life score will be determined by the completion of the 36-item Short Form (SF-36) Questionnaire
Measured: Baseline visit and Week 48 follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start6 Dec 2018
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Abuse or DependenceStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust, University of Hertfordshire
- Responsible party
- Sponsor
- Investigators
- Graham R Foster, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848000
- Sponsor's protocol ID
- Active over Alcohol study
- Acronym
- AOA
- Status last verified
- Oct 2024
- First submitted
- 14 Feb 2019
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Feasibility Study to Examine the Efficacy of a Combined Group-based Exercise and Educational Programme on Alcohol Consumption, Mental Health and Physical Health Among Alcohol-Dependent Adults
- ClinicalTrials.gov ID
- NCT03848000
- Acronym / sponsor ID
- AOA / Active over Alcohol study
- Conditions
- Alcohol Abuse or Dependence, Alcohol Use Disorder
- Keywords
- Alcohol abuse, Exercise, Alcohol consumption, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust, University of Hertfordshire
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is composed of two phases. Phase 1 will determine baseline demographic characteristics of participants, currently drinking harmful amounts of alcohol, who would be interested in an alternative treatment option to reduce alcohol consumption. Once baseline data is collected, participants will then be informed that the intervention is an exercise programme and those interested will be offered participation in Phase 2: a two-arm randomised controlled study. If eligible, participants will be randomly assigned to either: 1) a 12 week combined exercise programme and NHS standard care group, or 2) 12 weeks of NHS (National Health Service) standard care only group.
The aims are to study the feasibility of conducting a randomised controlled trial in this cohort and to determine the effectiveness of the exercise programme to reduce alcohol consumption, improve physical and mental health among people drinking harmful amounts of alcohol, compared to standard NHS care. Assessment visits, measuring alcohol consumption, mental health and physical health, will be conducted at baseline, and at Weeks 13, 24, 36 and 48 since commencement of the intervention period. Focus groups will take place during the 2nd and 12th week of the exercise programme where qualitative feedback on the exercise programme will be collected.
Detailed description
Alcohol-dependent patients often experience depression, anxiety and stress, and it is thought that these may be important factors associated with increased alcohol consumption. Regular moderate/high-intensity exercise has been repeatedly reported to reduce depression, anxiety and stress, with regular exercise also shown to be effective in achieving a pleasurable state, improving coping mechanisms and increasing self-confidence among substance-dependent patients. Additionally, exercise-based therapy may be perceived by alcohol-dependent patients as a less stigmatising therapy option than traditional medication and counselling treatments.
While a small number of studies suggest that regular exercise is effective in improving fitness levels among alcohol-dependent adults, there is a lack of consensus regarding the efficacy of regular exercise to reduce alcohol consumption. Of a recent systematic review, 3 of the 5 studies reported that regular exercise reduced alcohol consumption and craving of alcohol. However, while a recent meta-analysis didn't find evidence of exercise significantly reducing alcohol consumption, the three small studies that were assessed all found that exercise training induced some reductions in alcohol consumption; suggesting that regular exercise may be effective in reducing alcohol consumption.
This study is composed of two phases. Phase 1 will determine the characteristics of participants currently drinking harmful amounts of alcohol who would be interested in being offered a new, alternative treatment to reduce alcohol consumption. During their NHS standard care (Phase 1; Visit 1), potential participants will be asked by either a member of the study team, or by the standard care team, if they "would you be willing to consider taking part in a study to look at new ways of treating people addicted to alcohol?'. While no specific details of the intervention will be provided at this time, participants who are interested will be given the participant information sheet (Phase 1) which will include further details of the study. A member of the study team will contact potential participants and, if they are happy to take part, another visit (Phase 1; Visit 2) will be arranged for patients to complete the demographic questionnaires. Visit 2 will take place at one of the study sites and written informed consent will be taken before the patient completes the study questionnaires which will determine characteristics including age, gender, ethnicity, marital status, educational background, employment status, smoking status, number of previous attempts to reduce alcohol consumption, family history of addiction, other drug intake, alcohol consumption (7 Day Drinking Diary), dependence of alcohol consumption (Alcohol Use Disorders Identification Test (AUDIT) questionnaire), severity of alcohol dependence (SADQ), alcohol craving (Penn Alcohol Craving Scale), impact of alcohol consumption on daily life (Alcohol Problems Questionnaire), depression (Patient Health Questionnaire (PHQ-9)), anxiety (Generalised Anxiety Disorder (GAD-7) questionnaire) and current physical activity levels (short-form International Physical Activity Questionnaire (IPAQ)).
Participants who complete Phase 1 of the study will be invited to participate in Phase 2 of the study on the same day (i.e. at the end of Visit 2 of Phase 1 of the study). Interested participants will be provided with full information regarding the nature of the randomised controlled trial - i.e. that this is an exercise-based intervention study - and will be given a separate participant information sheet (Phase 2). A member of the study team will contact potential participants and, if they are happy to participate, the screening visit will be arranged. Participants who decline enrolment into the exercise-based randomized controlled trial will be asked if they are willing to take part in a short telephone interview to enquire about reasons for not wanting to partake in the study. Both participants who agree, and do not agree, to take part in the short telephone interview will be offered NHS standard care. The telephone interviews will be audio-recorded, with participants consent, and transcribed verbatim. This will allow us to identify the characteristics of participants who are interested in exercise. Baseline demographics and characteristics of participants offered the intervention, who consent to provision of data, will be recorded and compared to the demographics of those who decline to participate in the intervention.
Participants who agree to participate in Phase 2 of the study will undergo screening for eligibility. Written informed consent for Phase 2 of the study will be undertaken with a 2nd informed consent form. This visit will be conducted by a member of the study team at one of the NHS hospital sites and current medications and medical history will be recorded, as well as the Physical Activity Readiness Questionnaire (PARQ), to provide a screening measure of physical readiness for exercise. Only if the participant meets the inclusion/exclusion criteria will they be allowed to continue into the study. Participants who do not meet the inclusion/exclusion criteria will be informed that they are not eligible and will be offered NHS standard care. At the end of the screening visit, an accelerometer (Actigraph) will be provided to participants who will be asked to wear it for seven consecutive days in order to measure baseline physical activity levels.
Participants will return the accelerometer (from the screening visit) during the baseline testing visit and will complete the Alcohol Self-Efficacy Scale, Perceived Stress Scale and Short Form (SF-36) questionnaire, before having all physical health measurements (resting heart rate, resting blood pressure, stature, body mass, waist circumference, cardiorespiratory fitness) recorded. A venous blood sample will be collected to measure full blood count and liver enzyme biomarkers, while a finger-prick capillary blood sample will be collected to measure phosphatidylethanol (PEth); a marker of alcohol consumption.
Once the baseline testing visit is completed, participants will be randomly assigned to one of two groups: 1) a 12 week combined exercise (moderate/high-intensity) programme and NHS standard care group (n=48), or 2) 12 weeks of NHS standard care only group (n=48).
The exercise programme will take place in a local sports centre facility in East London, and will be delivered by qualified exercise coaches linked to West Ham United Football Club. Participants will be required to complete two sessions each week for 12 consecutive weeks, in addition to receiving NHS standard care consisting of counselling and support. Each session will begin with a 30 minute education talk (covering topics regarding the physical and mental health benefits of exercise and behaviour change) and will be followed by a 30-60 minute exercise session. Each exercise session will begin with a standard low-intensity 10 minute warm-up/stretch and end with a low-intensity 5 minute cool-down. The main body of the exercise session will utilise a combination of different exercise modalities, including pad-boxing, football and circuit training. The duration of exercise sessions will be gradually increased as follows: Weeks 1-2: 30 minutes; Weeks 3-4: 40 minutes; Weeks 5-6: 50 minutes; Weeks 7-12: 60 minutes. Recruitment of participants will be split into three separate intakes and each exercise group will consist of approximately 15 patients. Participants in the exercise programme will be invited to participate in focus groups on the 3rd session (week 2) and 24th session (week 12) of the exercise programme. The two focus groups will each last approximately 1 hour each and will be conducted by a member of the study team who is fully trained and experienced in undertaking focus group discussions. During the week 2 focus group, the topics for discussion will be the participant's knowledge and beliefs regarding exercise, their barriers to being physically active, their attitude and motivation to being physically active, their expectations of the exercise programme, and what challenges they foresee during the programme. During the week 12 focus group, the topics for discussion will be the participant's experience of the programme, the potential benefits of the programme and what impact it has had on their alcohol consumption, physical health and quality of life. The focus groups will be audio-recorded, with patients consent, and fully transcribed verbatim, anonymized and coded. A thematic analysis will be undertaken to identify recurring and salient themes that are conceptually and inherently significant.
Participants who are randomised to the NHS standard care only group will not receive the exercise programme but will be provided with NHS standard care at one of the NHS study sites. Participants will be provided with the name of their alcohol key worker and will receive a weekly one-to-one counselling alcohol addiction session lasting 1 hour where support and behavioural interventions will be offered, in line with current NHS practice. Drug therapy will be offered if indicated in line with standard therapy.
At the completion of the 12 week intervention period, participants in both the combined exercise programme and NHS standard care group, and the NHS standard care only group will complete 4 follow-up testing visits: at Week 13, Week 24, Week 36 and Week 48 after commencement of the study. These follow-up visits will coincide with the participants routine, clinically-necessary hospital visits. All follow-up visits will be conducted by a member of the study team at one of the NHS hospital sites. At the start of each of the follow-up visits, a member of the study team will verify that the participant is still happy to continue with their participation in the study. Participants will complete the alcohol consumption, physical health, mental health and physical activity questionnaires (the same as the baseline testing visit) at each follow-up testing visit. The finger-prick capillary blood sample, collected to measure phosphatidylethanol (PEth); a marker of alcohol consumption, will only be collected at the Week 24 follow-up visit. At the end of the Week 13 and Week 48 visits, the participant will be given an accelerometer and asked to wear it for seven consecutive days in order to measure physical activity levels over the next week. A visit window of 2 weeks will be set for the Week 13 follow-up testing visit while a visit window of 4 weeks will be set for the Week 24, Week 36 and Week 48 follow-up testing visits to allow for missed or rescheduled appointments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Programme and NHS Standard Care | Experimental | Other: Exercise Programme, Behavioral: NHS Standard CareExercise and NHS standard care. |
| NHS Standard Care only | Active comparator | Behavioral: NHS Standard CareAlcohol addiction counselling. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 65 years old
- AUDIT score of ≥ 8
- In the opinion of the referring physician, is capable of performing moderate/high-intensity exercise
- Agrees to their GP being informed of their participation
- Able and willing to provide written informed consent and complete the study questionnaires
Key exclusion criteria (5 listed)
- Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine.
- Have anorexia, bipolar disorder or severe (unstable) psychosis disorder which may preclude active participation.
- In the opinion of the referring physician, is physically incapable or likely to be incapable of undertaking an exercise programme.
- Pregnant or planning pregnancy within the first 3 months after randomisation.
- Currently participating in >90 minutes/week of structured moderate-intensity exercise, such as jogging, cycling or swimming (not including walking).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgrammeTwo sessions per week for 12 consecutive weeks. 30 minute education talks covering topics regarding the physical and mental health benefits of exercise and behaviour change. The following 30-60 minute exercise sessions will utilise pad-boxing, football, body-weight training and circuit training. | Other | Exercise Programme and NHS Standard Care |
| NHS Standard CareWeekly one-to-one cognitive-behavioral counselling alcohol addiction support session lasting 1 hour. Drug therapy will be offered if indicated in line with standard therapy. | Behavioural | Exercise Programme and NHS Standard Care, NHS Standard Care only |
Primary outcome
Change in absolute total weekly alcohol consumption from baseline, at 13 weeks follow-up
Time frame: Baseline visit and Week 13 follow-up visit
The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)
Change in absolute total weekly alcohol consumption from baseline, at 24 weeks follow-up
Time frame: Baseline visit and Week 24 follow-up visit
The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)
Change in absolute total weekly alcohol consumption from baseline, at 36 weeks follow-up
Time frame: Baseline visit and Week 36 follow-up visit
The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)
Change in absolute total weekly alcohol consumption from baseline, at 48 weeks follow-up
Time frame: Baseline visit and Week 48 follow-up visit
The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)
97 secondary outcomes
Change in number of drinking days per week from baseline, at 13 weeks follow-up
Time frame: Baseline visit and Week 13 follow-up visit
Change in number of drinking days per week from baseline, at 24 weeks follow-up
Time frame: Baseline visit and Week 24 follow-up visit
Change in number of drinking days per week from baseline, at 36 weeks follow-up
Time frame: Baseline visit and Week 36 follow-up visit
Change in number of drinking days per week from baseline, at 48 weeks follow-up
Time frame: Baseline visit and Week 48 follow-up visit
Change in number of heavy drinking days per week from baseline, at 13 weeks follow-up
Time frame: Baseline visit and Week 13 follow-up visit
Change in number of heavy drinking days per week from baseline, at 24 weeks follow-up
Time frame: Baseline visit and Week 24 follow-up visit
Change in number of heavy drinking days per week from baseline, at 36 weeks follow-up
Time frame: Baseline visit and Week 36 follow-up visit
Change in number of heavy drinking days per week from baseline, at 48 weeks follow-up
Time frame: Baseline visit and Week 48 follow-up visit
Change in number of alcohol free days per week from baseline, at 13 weeks follow-up
Time frame: Baseline visit and Week 13 follow-up visit
Change in number of alcohol free days per week from baseline, at 24 weeks follow-up
Time frame: Baseline visit and Week 24 follow-up visit
Change in number of alcohol free days per week from baseline, at 36 weeks follow-up
Time frame: Baseline visit and Week 36 follow-up visit
Change in number of alcohol free days per week from baseline, at 48 weeks follow-up
Time frame: Baseline visit and Week 48 follow-up visit
Change in Alcohol Use Disorders Identification Test (AUDIT) score from baseline, at 13 weeks follow-up
Time frame: Baseline visit and Week 13 follow-up visit
Change in Alcohol Use Disorders Identification Test (AUDIT) score from baseline, at 24 weeks follow-up
Time frame: Baseline visit and Week 24 follow-up visit
Change in Alcohol Use Disorders Identification Test (AUDIT) score from baseline, at 36 weeks follow-up
Time frame: Baseline visit and Week 36 follow-up visit
Change in Alcohol Use Disorders Identification Test (AUDIT) score from baseline, at 48 weeks follow-up
Time frame: Baseline visit and Week 48 follow-up visit
Change in Severity of Alcohol Dependence Questionnaire (SADQ) score from baseline, at 13 weeks follow-up
Time frame: Baseline visit and Week 13 follow-up visit
Change in Severity of Alcohol Dependence Questionnaire (SADQ) score from baseline, at 24 weeks follow-up
Time frame: Baseline visit and Week 24 follow-up visit
Change in Severity of Alcohol Dependence Questionnaire (SADQ) score from baseline, at 36 weeks follow-up
Time frame: Baseline visit and Week 36 follow-up visit
Change in Severity of Alcohol Dependence Questionnaire (SADQ) score from baseline, at 48 weeks follow-up
Time frame: Baseline visit and Week 48 follow-up visit
Change in alcohol cravings from baseline, at 13 weeks follow-up
Time frame: Baseline visit and Week 13 follow-up visit
Change in alcohol cravings from baseline, at 24 weeks follow-up
Time frame: Baseline visit and Week 24 follow-up visit
Change in alcohol cravings from baseline, at 36 weeks follow-up
Time frame: Baseline visit and Week 36 follow-up visit
Change in alcohol cravings from baseline, at 48 weeks follow-up
Time frame: Baseline visit and Week 48 follow-up visit
Change in abstinence self-efficacy from baseline, at 13 weeks follow-up
Time frame: Baseline visit and Week 13 follow-up visit
Change in abstinence self-efficacy from baseline, at 24 weeks follow-up
Time frame: Baseline visit and Week 24 follow-up visit
Change in abstinence self-efficacy from baseline, at 36 weeks follow-up
Time frame: Baseline visit and Week 36 follow-up visit
Change in abstinence self-efficacy from baseline, at 48 weeks follow-up
Time frame: Baseline visit and Week 48 follow-up visit
Change in alcohol problems from baseline, at 13 weeks follow-up
Time frame: Baseline visit and Week 13 follow-up visit
Change in alcohol problems from baseline, at 24 weeks follow-up
Time frame: Baseline visit and Week 24 follow-up visit
Change in alcohol problems from baseline, at 36 weeks follow-up
Time frame: Baseline visit and Week 36 follow-up visit
Change in alcohol problems from baseline, at 48 weeks follow-up
Time frame: Baseline visit and Week 48 follow-up visit
Change in blood phosphatidylethanol (PEth) from baseline, at 24 weeks follow-up
Time frame: Baseline visit and Week 24 follow-up visit
Change in blood gamma glutamyl transferase from baseline, at 13 weeks follow-up
Time frame: Baseline visit and Week 13 follow-up visit
Change in blood gamma glutamyl transferase from baseline, at 24 weeks follow-up
Time frame: Baseline visit and Week 24 follow-up visit
Change in blood gamma glutamyl transferase from baseline, at 36 weeks follow-up
Time frame: Baseline visit and Week 36 follow-up visit
Change in blood gamma glutamyl transferase from baseline, at 48 weeks follow-up
Time frame: Baseline visit and Week 48 follow-up visit
Change in blood alanine aminotransferase from baseline, at 13 weeks follow-up
Time frame: Baseline visit and Week 13 follow-up visit
Change in blood alanine aminotransferase from baseline, at 24 weeks follow-up
Time frame: Baseline visit and Week 24 follow-up visit
Change in blood alanine aminotransferase from baseline, at 36 weeks follow-up
Time frame: Baseline visit and Week 36 follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham R Foster principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Programme in people with Alcohol Abuse or Dependence and Alcohol Use Disorder, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in absolute total weekly alcohol consumption from baseline, at 13 weeks follow-up (time frame: Baseline visit and Week 13 follow-up visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.