Substance-related DisordersPHASTNCT02309021
PHAST: Physical Activity in Substitution Therapy
A study testing Sport and Non-sport activities in people with Substance-related Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim is to examine the effect of exercise (EX) training on individuals currently receiving ST - either opiate replacement therapy (ORT) or heroin-assisted treatment (HAT) - for their opiate dependence. Main outcome variables will be: cardiovascular fitness; consumption of substances (e.g. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Substance-related Disorders
- What is being tested?
- Sport and Non-sport activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Nov 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at the Ambulanter Dienst Sucht or Janus clinics in Basel Town (BS); currently under substitution therapy
Who cannot join
- Declared unfit to participate by clinic personnel due to physical disability or severe psychological disturbance or cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PHAST: Influence of Exercise Training on Substance Use, Substance Craving, Quality of Life, Mental Health, Sleep, and Physical Health in Patients Suffering From Opiate Dependence While Under Substitution Therapy
The aim is to examine the effect of exercise (EX) training on individuals currently receiving ST - either opiate replacement therapy (ORT) or heroin-assisted treatment (HAT) - for their opiate dependence. Main outcome variables will be: cardiovascular fitness; consumption of substances (e.g. "street heroin", cocaine, cannabis, alcohol, cigarettes) other than prescribed ST or other prescribed medications; substance craving; blood pressure; lung function; resting pulse; social interaction; self-control capacity; objective and subjective sleep; cortisol levels; quality adjusted life years (QALYs); depression; mood. Covariates are current substitution dose and psychiatric diagnoses.
Read the detailed description
The investigators aim is to carry out a randomized controlled trial comparing exercise training group and a control group of patients receiving substitution therapy (ST). The specific goals of the study are:
- To understand the exercise preferences, barriers to participation, motivation, experiences and attitudes regarding exercise training in patients under ST.
- To examine whether a 12-week exercise programme affects the mental health, subjective and objective sleep, quality of life, self-control capacity, substance craving, hair cortisol levels, secondary consumption, cardiovascular fitness, blood pressure, lung function, resting pulse, and social interaction in patients receiving ST.
- To compare the effects of the EX and control conditions on the above-mentioned outcome variables.
- To examine to what degree the covariates of heroin substitution dose and psychiatric comorbidities affect outcome variables.
- To explore to what extent objective variables (cardiovascular fitness, pulse, blood pressure, lung function, cortisol, objective sleep-EEG-parameters) and subjective-psychological dimensions (subjective sleep, social interaction, symptoms of depression and anxiety, self-control, substance craving) are interrelated.
- Conditions
- Substance-related Disorders
- Being tested
- Sport, Non-sport activities
- Keywords
- craving
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SportOther
Non-sport activitiesOther
| Study group | Role | What they receive |
|---|---|---|
| Sport Group | Other | Participants randomised to the exercise condition will receive 12 weeks of physical exercise training. Once they have been assigned to this group, they will be informed about the training programme and its content. Training will be carried out in groups (two groups of ten or four groups of five, depending on scheduling, sport preferences, available materials) to ensure that individual attention can be paid to each participant. Receives: Other: Sport |
| Control Group | Other | The control group will not receive any exercise training. In order to control, as far as possible, for the potentially therapeutic effects of extra contact time with investigators, and the potentially motivational elements of participation in an intervention, the C group will have equal contact time with an investigator and participate in a leisure program without physical activity component. This time will be filled with group mealtimes, games, films, painting, handcrafts, stretching or relaxation exercises. Receives: Other: Non-sport activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving measured by the Brief Substance Craving Scale (translated)
Craving will be measured by the Brief Substance Craving Scale (translated)
Measured: 6 months
Secondary substance consumption assessed using the Time Line Follow Back method
This will be assessed using the Time Line Follow Back method
Measured: 6 months
Secondary outcomes (9)
Depression assessed using the Allgemeine Depressionskala ( Depression Scale)
Depression will be assessed using the Allgemeine Depressionskala ( Depression Scale)
Measured: 6 months
Self control measured using the Short Self Control Scale (translated)
This will be measured using the Short Self Control Scale (translated)
Measured: 6 months
Subjective sleep measured using the Insomnia Severity Index (translated)
This will be measured using the Insomnia Severity Index (translated)
Measured: 6 months
Physical activity level measured using the International Physical Activity Questionnaire
This will be measured using the International Physical Activity Questionnaire
Measured: 6 months
Perceived Stress measured using the Perceived Stress Scale (translated)
Will be measured using the Perceived Stress Scale (translated)
Measured: 6 months
Quality adjusted life years assessed using the Short Form (SF)36 questionnaire
This will be assessed using the Short Form (SF)36 questionnaire
Measured: 6 months
Blood pressure measured using a digital sphygmomanometer
This will be measured using a digital sphygmomanometer
Measured: 6 months
Lung function measured with a Spirobank Spirometer
Lung function will be measured with a Spirobank Spirometer
Measured: 6 months
Hand grip strength assessed using a Hydraulic Hand Dynamometer.
This will be assessed using a Hydraulic Hand Dynamometer.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-related DisordersStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric Hospital of the University of Basel
- Responsible party
- Sponsor
- Investigators
- Flora Colledge, PhD, Principal investigator, Department for Sport, Exercise and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309021
- Sponsor's protocol ID
- UHospitalSwitz
- Acronym
- PHAST
- Status last verified
- Dec 2015
- First submitted
- 27 Nov 2014
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHAST: Influence of Exercise Training on Substance Use, Substance Craving, Quality of Life, Mental Health, Sleep, and Physical Health in Patients Suffering From Opiate Dependence While Under Substitution Therapy
- ClinicalTrials.gov ID
- NCT02309021
- Acronym / sponsor ID
- PHAST / UHospitalSwitz
- Conditions
- Substance-related Disorders
- Keywords
- craving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Psychiatric Hospital of the University of Basel
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Dec 2014 (estimated)
- 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.
The aim is to examine the effect of exercise (EX) training on individuals currently receiving ST - either opiate replacement therapy (ORT) or heroin-assisted treatment (HAT) - for their opiate dependence. Main outcome variables will be: cardiovascular fitness; consumption of substances (e.g. "street heroin", cocaine, cannabis, alcohol, cigarettes) other than prescribed ST or other prescribed medications; substance craving; blood pressure; lung function; resting pulse; social interaction; self-control capacity; objective and subjective sleep; cortisol levels; quality adjusted life years (QALYs); depression; mood. Covariates are current substitution dose and psychiatric diagnoses.
Detailed description
The investigators aim is to carry out a randomized controlled trial comparing exercise training group and a control group of patients receiving substitution therapy (ST). The specific goals of the study are:
- To understand the exercise preferences, barriers to participation, motivation, experiences and attitudes regarding exercise training in patients under ST.
- To examine whether a 12-week exercise programme affects the mental health, subjective and objective sleep, quality of life, self-control capacity, substance craving, hair cortisol levels, secondary consumption, cardiovascular fitness, blood pressure, lung function, resting pulse, and social interaction in patients receiving ST.
- To compare the effects of the EX and control conditions on the above-mentioned outcome variables.
- To examine to what degree the covariates of heroin substitution dose and psychiatric comorbidities affect outcome variables.
- To explore to what extent objective variables (cardiovascular fitness, pulse, blood pressure, lung function, cortisol, objective sleep-EEG-parameters) and subjective-psychological dimensions (subjective sleep, social interaction, symptoms of depression and anxiety, self-control, substance craving) are interrelated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sport Group | Other | Other: SportParticipants randomised to the exercise condition will receive 12 weeks of physical exercise training. Once they have been assigned to this group, they will be informed about the training programme and its content. Training will be carried out in groups (two groups of ten or four groups of five, depending on scheduling, sport preferences, available materials) to ensure that individual attention can be paid to each participant. |
| Control Group | Other | Other: Non-sport activitiesThe control group will not receive any exercise training. In order to control, as far as possible, for the potentially therapeutic effects of extra contact time with investigators, and the potentially motivational elements of participation in an intervention, the C group will have equal contact time with an investigator and participate in a leisure program without physical activity component. This time will be filled with group mealtimes, games, films, painting, handcrafts, stretching or relaxation exercises. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient at the Ambulanter Dienst Sucht or Janus clinics in Basel Town (BS); currently under substitution therapy
Key exclusion criteria (1 listed)
- Declared unfit to participate by clinic personnel due to physical disability or severe psychological disturbance or cognitive impairment
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 |
|---|---|---|
| Sport | Other | Sport Group |
| Non-sport activities | Other | Control Group |
Primary outcome
Craving measured by the Brief Substance Craving Scale (translated)
Time frame: 6 months
Craving will be measured by the Brief Substance Craving Scale (translated)
Secondary substance consumption assessed using the Time Line Follow Back method
Time frame: 6 months
This will be assessed using the Time Line Follow Back method
9 secondary outcomes
Depression assessed using the Allgemeine Depressionskala ( Depression Scale)
Time frame: 6 months
Self control measured using the Short Self Control Scale (translated)
Time frame: 6 months
Subjective sleep measured using the Insomnia Severity Index (translated)
Time frame: 6 months
Physical activity level measured using the International Physical Activity Questionnaire
Time frame: 6 months
Perceived Stress measured using the Perceived Stress Scale (translated)
Time frame: 6 months
Quality adjusted life years assessed using the Short Form (SF)36 questionnaire
Time frame: 6 months
Blood pressure measured using a digital sphygmomanometer
Time frame: 6 months
Lung function measured with a Spirobank Spirometer
Time frame: 6 months
Hand grip strength assessed using a Hydraulic Hand Dynamometer.
Time frame: 6 months
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 11 Dec 2015.
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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.
Flora Colledge, PhD principal investigator
Department for Sport, Exercise and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sport and Non-sport activities in people with Substance-related Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 1 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 11 Dec 2015. 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 Switzerland. 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?
Craving measured by the Brief Substance Craving Scale (translated) (time frame: 6 months). The study lists 2 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 11 Dec 2015.