Major Depressive DisorderNCT03959735
High Intensity Interval Training in Severe Mental Illness
A study testing High Intensity Interval Training (HIIT) in people with Major Depressive Disorder and Bipolar Disorder, run by King's College London at 2 sites in United Kingdom.
Trial summary
People experiencing severe mental illnesses (SMI), including schizophrenia, psychosis, bipolar disorder and major depressive disorder, are prone to poorer physical health and increased incidences of premature mortality when compared to the general population (De Hert et al., 2009; Hert et al., 2011; Hennekens et al.… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder, Schizophrenia
- What is being tested?
- High Intensity Interval Training (HIIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 10 Oct 2019to 30 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 1 (Focus Groups):
- Capacity to provide informed consent.
- Aged ≥18 years.
- Either be: 1) Inpatients at SLaM with a diagnosis of SMI (Major Depressive Disorder, Bipolar disorder, Schizophrenia Spectrum Disorders, 2) Carers providing unpaid support to someone with a SMI, 3) Clinical staff at SLaM.
- Stage 2 (HIIT Pilot RCT):
- Inpatients at SLaM with a diagnosis of SMI.
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- Capacity to provide informed consent.
- Aged 18 -60.
- Ready to exercise according to the Physical Activity Readiness Questionnaire.
- Stage 3 (Follow-up): Qualitative interview:
- inpatients who were eligible for stage 2.
- Stage 3 (Follow-up): Focus group:
- staff who participated in stage 1.
Who cannot join
- Stage 1 (Focus Groups):
- Is aged <18 years old.
- Stage 2 (HIIT Pilot RCT) \& Stage 3 qualitative interviews:
- Is aged <18 years old or >60 years old.
- Is pregnant.
- Has an eating disorder.
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- Has a medical condition that impedes exercise, (as assessed via discussion with the patient's clinical team).
- Stage 3 focus group:
- Did not complete stage one.
- ALL STAGES:
- Is unable to provide informed consent.
- Is unable to understand English.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Bethlem Royal Hospital, South London and maudsley NHS Trust
London, BR3 3BX
Maudsley Hospital, South London and Maudsley NHS Trust
London, SE5 8AZ
About this study
Official title: "Is the Use of High Intensity Interval Training (HIIT) Feasible and Acceptable Amongst Inpatients With Severe Mental Illness (SMI)?" A Pilot Study
People experiencing severe mental illnesses (SMI), including schizophrenia, psychosis, bipolar disorder and major depressive disorder, are prone to poorer physical health and increased incidences of premature mortality when compared to the general population (De Hert et al., 2009; Hert et al., 2011; Hennekens et al., 2005; Tiihonen et al., 2009 . High-intensity-interval-training (HIIT) is a type of exercise involving alternating short bursts of high intensity exercise with recovery periods of rest/ light exercise (Weston, Wisløff \& Coombes, 2014). HIIT improves physical health, quality of life and cognition in the general population and in those with physical health disorders (Gomes-Neto et al., 2017; Hwang, Wu \& Chou, 2011; Wen et al., 2019). It has been proposed that HIIT may improve symptoms, physical health and time to discharge among inpatients with SMI.
The research will involve three stages: 1) Focus groups, 2) A pilot study, 3) Follow-up qualitative interviews and focus groups.
Read more
Firstly, a series of focus groups with inpatients with SMI, carers of individuals with SMI and clinical staff will be conducted. The focus groups will scope perceptions of attitudes, and practicalities of a pilot RCT. The information gained will be used to inform a pilot HIIT trial which will evaluate whether HIIT is acceptable and feasible amongst this population group. Each focus group will run for ≈2 hours and will involve an open discussion about the benefits and barriers of conducting HIIT exercise sessions in a population with SMI.
Secondly, the HIIT pilot study will be trialed. The final protocol will be developed with feedback from the focus group but will involve an RCT where 12 weeks of HIIT will be compared to 12 weeks of treatment-as-usual (TAU). HIIT will be conducted, twice a week, in a supervised environment using a stationary bike. Inpatients with a diagnosis of SMI will be eligible to participate. Thirdly, follow-up qualitative interviews, with pilot study participants, those that withdrew and those that did not want to take part, and focus groups with clinical staff will address the acceptability and feasibility of HIIT.
Read the detailed description
Setting:
All three stages will take place in various South London and Maudsley Hospital NHS Trust (SLaM) Adult Mental Health settings affiliated with the Maudsley Hospital and the Bethlem Royal Hospital, and at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN).
Stage One:
A series of focus groups with inpatients with a diagnosis of SMI, carers of people with a diagnosis of SMI and clinical staff will scope perceptions of attitudes, and practicalities of a pilot RCT. It is expected that between 6-8 people will attend each focus group.
Up to 5 focus groups will be conducted, lasting two hours each, addressed at the following populations: 1) Clinical staff affiliated with SLaM; 2) Inpatients with a diagnosis of SMI who reside at the Maudsley Hospital and the Bethlem Royal Hospital, and their carers; 3) Carers recruited via the national carers' forum, a carers group in SLaM.
Procedure: A series of simple open-ended questions will be asked, and participants will answer verbally. The questions will address factors relevant to the pilot study design including optimal duration and intensity of exercise sessions; location of exercise sessions; procedures surrounding storage of exercise equipment; and procedure surrounding outcome assessments. An audio-recording will record responses to these questions when permission has been granted. The qualitative data gained from the questions asked as part of the focus group will be analysed using thematic analysis to understand the main themes.
Stage Two:
Part a- A pilot RCT will be conducted whereby inpatients with a diagnosis of SMI will be randomly allocated to either 12 weeks of HIIT or 12 weeks of TAU. For patients in the HIIT arm, HIIT will be conducted twice a week for 12 weeks using a stationary bike. Each session will have the following structure: 4-minute warm-up, followed by 5X1 minute intervals at 85-95% of maximum heart rate, interspersed with active pauses of 90 seconds cycling at approximately 60-70% of maximum heart rate, and a 4-minute cool-down. Assessment measures including a neuropsychological test battery; fitness test; and physical health checks will be conducted at baseline, 6-, and 12-weeks. Twenty inpatients will be recruited to each arm of the RCT (40 inpatients in total). This number is based on recruiting a big-enough sample to assess the feasibility of the study and on the resources available (Leon, Davis \& Kraemer, 2011).
Pre-post intervention changes in will be measured, including changes in neuropsychological outcomes, fitness, physical health, and cardiovascular risk. A between-group analysis will also be conducted to see whether any changes in outcome differ from the control (TAU) group.
Part b- The RCT commenced in January 2020 using the above RCT procedure. Recruitment was halted in March 2020 at the start of the Covid-19 pandemic and HIIT sessions were ceased. The data gained will be analysed as above using an intention-to-treat basis.
In light of easing of lockdown the HIIT trial will resume using a remote cohort design. All eligible participants will receive HIIT, no randomisation will take place. A cohort design will be employed due to the smaller number of SMI patients receiving inpatient treatment during the outbreak/ slow resumption of inpatient admissions, thus it is unlikely that there will be enough numbers to randomise patients. The study primary and secondary outcomes remain the same.
HIIT sessions will resume remotely. This data will be analysed separately to existing data gathered from the RCT. A pre-post analysis on an ITT basis and a subgroup of those with 64% adherence will take place. The research team will conduct HIIT sessions remotely via a projector screen but a member of the ward will supervise sessions in person. Adverse events/ injuries/ difficulties will be observed by both the researcher remotely and the in-person staff member. Baseline and follow-up assessments will be conducted remotely via a projector screen/ telephone call for questionnaire measures.
A target of 6-8 patients will be recruited to the cohort study design.
Stage Three:
- Qualitative interviews: Participants who completed the pilot study will be invited to take part in individual semi-structured follow-up qualitative interviews. Feedback regarding the acceptability and feasibility of the study will be sought. Additionally, feedback will be sought from those that withdrew from the study and those that did not agree to take part. The interviews will assess 1) how participants experienced the intervention, 2) if there are any parts of the intervention that could be improved, and what factors influenced people in completing/not completing the intervention. Interviews will take place on a one-to-one basis with a member of the research team and a participant. Each qualitative interview will be conducted within 3 weeks of each participant finishing the HIIT pilot study/ within 3 weeks of drop-out if time commitments permit. Responses will be recorded when permission has been granted. Overall, each individual interview will take 30- 60 minutes and will not require participants to participate in any follow-up tasks. The qualitative data gained from these questions will be analysed using thematic analysis to understand the main themes.
- Focus groups:
Up to two focus groups with clinical staff at SLaM will be conducted and feedback regarding the acceptability and feasibility of the pilot HIIT study conducted in stage two of the research project will be sought. It is expected that between 6-8 people will attend each focus group. A series of simple open-ended questions will be asked, and participants will answer verbally. The questions will address staff's opinions regarding the acceptability and feasibility of conducting HIIT in a mental health setting. An audio-recording will record responses to these questions when permission has been granted. The qualitative data gained from these questions will be analysed using thematic analysis to understand the main themes. Overall, each focus group should take no more than 2 hours and will not require participants to participate in any follow-up tasks.
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Schizophrenia
- Being tested
- High Intensity Interval Training (HIIT)
- Keywords
- inpatients
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Training (HIIT)Other
HIIT is a type of exercise involving alternating short bursts of high intensity exercise with recovery periods of rest or light exercise.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | 50% of participants (inpatients with a diagnosis of severe mental illness) will be randomised to HIIT. HIIT will be conducted twice a week for 12 weeks using a stationary bike. Each session will have the following structure: 4-minute warm-up, followed by 5X1 minute intervals at 85-95% of maximum heart rate, interspersed with active pauses of 90 seconds cycling at approximately 60-70% of maximum heart rate, and a 4-minute cool-down. Each exercise session will take 19 minutes to complete (11 minutes of HIIT + warm-up and cool-down). However, the amount of HIIT will be adapted for people who may be unable to complete the above target and gradually build up until they can complete the recommended amount.
All exercise sessions will be conducted in a 1:1 environment with a participant and a member of the research team who will supervise the exercise session. Receives: Other: High Intensity Interval Training (HIIT) |
| Treatment As Usual (TAU) | No intervention | 50% of participants will be randomised to TAU. They will be provided with details of the local hospital gym availability and instructed to maintain their usual dietary habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of wards that agree to hosting the HIIT Pilot Study and number that do not agree to hosting the HIIT pilot study
as assessed via a tally of acceptances and refusals
Measured: Through study completion, an average of 1 year
Number of people who consent to take part
as assessed via a tally of acceptances and refusals
Measured: Through study completion, an average of 1 year
Average adherence to HIIT sessions and assessments
as assessed via a record of number of HIIT sessions and number of assessments attended, and number of HIIT sessions and assessments not attended
Measured: Throughout length of participation in the HIIT trial, 12 weeks
Number of Participants With Treatment-Related Adverse Events
as assessed via a tally of all medical effects observed and all medical effects reported by participants
Measured: Through study completion, an average of 1 year
Secondary outcomes (16)
BMI
BMI will be measured according to criteria set out by the International Diabetes Federation (IDF). A BMI between 18.5 to 24.9 will be interpreted as a healthy weight. Scores between 25 and 29.9 will be interpreted as overweight and a BMI >30kg/m² will be classified as central obesity.
Measured: baseline, 6-weeks, 12-weeks
Weight
Weight will be measured in Kg using household scales. The investigators will assess whether weight decreases after participation in the HIIT trial.
Measured: baseline, 6-weeks, 12-weeks
Waist Circumference (WC)
WC will be measured according to criteria set out by the International Diabetes Febderation (IDF). For Europids, a WC ≥ 94 cm and ≥ 80 cm indicates central obesity for men and women respectively. For persons from South Asia, China and Japan the cut-offs are ≥ 90 cm and ≥ 80 cm for men and women respectively.
Measured: baseline, 6-weeks, 12-weeks
Systolic and diastolic blood pressure
Blood pressure will be measured using a blood pressure monitor. Higher systolic and diastolic blood pressure indicates lower cardiovascular function.
Measured: baseline, 6-weeks, 12-weeks
Maximal oxygen uptake (VO2max)
VO2max will be measured using the YMCA cycle ergometer test which is a graded exercise test. Higher VO2max scores indicate greater cardiorespiratory fitness.
Measured: baseline, 6-weeks, 12-weeks
Gait speed
The investigators will measure time taken to walk 6 meters. Longer times indicate reduced physical fitness.
Measured: baseline, 6-weeks, 12-weeks
Change in Montreal Cognitive Assessment (MoCA) score
MoCA scores range between 0 and 30. Lower scores indicate worse cognitive functioning. A score of 26 or over is considered to be normal.
Measured: baseline, 6-weeks, 12-weeks
Change in global assessment of functioning scale (GAF) score
GAF scores range from 0-100. Lower scores indicate worse global functioning. A score under 50 indicates severe impairment to functioning.
Measured: baseline, 6-weeks, 12-weeks
Change in Brief Psychiatric Rating Scale (BPRS) score
The BPRS measures depression, anxiety, hallucinations and unusual behaviour. 24 items are rated from 1-7. A higher score indicates more severe psychiatric symptoms.
Measured: baseline, 6-weeks, 12-weeks
Change in the brief insomnia severity index (ISI)
ISI scores range from 0-28. 0-7 indicates no clinically significant insomnia, 8-14 indicates sub-threshold insomnia and 15-28 indicates clinical insomnia.
Measured: baseline, 6-weeks, 12-weeks
Cigarette intake
Participants will be asked how many cigarettes they smoke on a typical day.
Measured: baseline, 6-weeks, 12-weeks
Change in Depression Anxiety Stress Scale short version (DASS21) score
The DASS21 contains 7 items for depression, 7 for anxiety and 7 for stress. Each subscale is scored from 0-42. Higher scores indicate higher levels of depression, anxiety and stress. Scores of 21, 15 and 26 indicate severe depression, anxiety and stress respectively.
Measured: baseline, before and after the first HIIT session (or before and after 19 minutes of rest for the TAU arm), 6-weeks, 12-weeks
Change in the Rosenberg Self-Esteem Scale (RSES) score
RSES scores range from 0-30. Lower scores indicate lower self-esteem. A score under 15 may indicate problematic low self-esteem.
Measured: baseline, 6-weeks, 12-weeks
Change in the International Physical Activity Questionnaire (IPAQ) score
Participants are asked to quantify how much physical activity they have completed over the past 7 days.
Measured: baseline, 6-weeks, 12-weeks
Change in the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) score
The BREQ contains 24 items with a score ranging from 0-4 for each item. The items are grouped into 6 factors with 4 items in each factor. Scores from each factor are combined using a weighting approach. Higher, positive scores indicate greater relative autonomy; lower, negative scores indicate more controlled regulation.
Measured: baseline, 6-weeks, 12-weeks
Change in the Short Warwick Edinburgh Mental Well-being Scale (WEMWBS) score
Scores range from 7 to 35 and higher scores indicate higher positive mental well-being.
Measured: baseline, 6-weeks, 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start10 Oct 2019
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility Randomized Controlled Trial (RCT)
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Brendon Stubbs, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959735
- Sponsor's protocol ID
- IRAS263996
- Status last verified
- Sep 2020
- First submitted
- 17 May 2019
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.
PubMed 21035130DE Hert M, Correll CU, Bobes J, Cetkovich-Bakmas M, Cohen D, Asai I, Detraux J, Gautam S, Moller HJ, Ndetei DM, Newcomer JW, Uwakwe R, Leucht S. Physical illness in patients with severe mental disorders. I. Prevalence, impact of medications and disparities in health care. World Psychiatry. 2011 Feb;10(1):52-77. doi: 10.1002/j.2051-5545.2011.tb00014.x.
PubMed 21379357De Hert M, Dekker JM, Wood D, Kahl KG, Holt RI, Moller HJ. Cardiovascular disease and diabetes in people with severe mental illness position statement from the European Psychiatric Association (EPA), supported by the European Association for the Study of Diabetes (EASD) and the European Society of Cardiology (ESC). Eur Psychiatry. 2009 Sep;24(6):412-24. doi: 10.1016/j.eurpsy.2009.01.005. Epub 2009 Aug 13.
PubMed 19682863Hennekens CH, Hennekens AR, Hollar D, Casey DE. Schizophrenia and increased risks of cardiovascular disease. Am Heart J. 2005 Dec;150(6):1115-21. doi: 10.1016/j.ahj.2005.02.007.
PubMed 16338246Tiihonen J, Lonnqvist J, Wahlbeck K, Klaukka T, Niskanen L, Tanskanen A, Haukka J. 11-year follow-up of mortality in patients with schizophrenia: a population-based cohort study (FIN11 study). Lancet. 2009 Aug 22;374(9690):620-7. doi: 10.1016/S0140-6736(09)60742-X.
PubMed 19595447Weston KS, Wisloff U, Coombes JS. High-intensity interval training in patients with lifestyle-induced cardiometabolic disease: a systematic review and meta-analysis. Br J Sports Med. 2014 Aug;48(16):1227-34. doi: 10.1136/bjsports-2013-092576. Epub 2013 Oct 21.
PubMed 24144531Martland R, Onwumere J, Stubbs B, Gaughran F. Study protocol for a pilot high-intensity interval training intervention in inpatient mental health settings: a two-part study using a randomised controlled trial and naturalistic study design. Pilot Feasibility Stud. 2021 Nov 8;7(1):198. doi: 10.1186/s40814-021-00937-6.
PubMed 34749822
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Is the Use of High Intensity Interval Training (HIIT) Feasible and Acceptable Amongst Inpatients With Severe Mental Illness (SMI)?" A Pilot Study
- ClinicalTrials.gov ID
- NCT03959735
- Acronym / sponsor ID
- IRAS263996
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Schizophrenia
- Keywords
- inpatients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, South London and Maudsley NHS Foundation Trust
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 22 May 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.
People experiencing severe mental illnesses (SMI), including schizophrenia, psychosis, bipolar disorder and major depressive disorder, are prone to poorer physical health and increased incidences of premature mortality when compared to the general population (De Hert et al., 2009; Hert et al., 2011; Hennekens et al., 2005; Tiihonen et al., 2009 . High-intensity-interval-training (HIIT) is a type of exercise involving alternating short bursts of high intensity exercise with recovery periods of rest/ light exercise (Weston, Wisløff \& Coombes, 2014). HIIT improves physical health, quality of life and cognition in the general population and in those with physical health disorders (Gomes-Neto et al., 2017; Hwang, Wu \& Chou, 2011; Wen et al., 2019). It has been proposed that HIIT may improve symptoms, physical health and time to discharge among inpatients with SMI.
The research will involve three stages: 1) Focus groups, 2) A pilot study, 3) Follow-up qualitative interviews and focus groups.
Firstly, a series of focus groups with inpatients with SMI, carers of individuals with SMI and clinical staff will be conducted. The focus groups will scope perceptions of attitudes, and practicalities of a pilot RCT. The information gained will be used to inform a pilot HIIT trial which will evaluate whether HIIT is acceptable and feasible amongst this population group. Each focus group will run for ≈2 hours and will involve an open discussion about the benefits and barriers of conducting HIIT exercise sessions in a population with SMI.
Secondly, the HIIT pilot study will be trialed. The final protocol will be developed with feedback from the focus group but will involve an RCT where 12 weeks of HIIT will be compared to 12 weeks of treatment-as-usual (TAU). HIIT will be conducted, twice a week, in a supervised environment using a stationary bike. Inpatients with a diagnosis of SMI will be eligible to participate. Thirdly, follow-up qualitative interviews, with pilot study participants, those that withdrew and those that did not want to take part, and focus groups with clinical staff will address the acceptability and feasibility of HIIT.
Detailed description
Setting:
All three stages will take place in various South London and Maudsley Hospital NHS Trust (SLaM) Adult Mental Health settings affiliated with the Maudsley Hospital and the Bethlem Royal Hospital, and at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN).
Stage One:
A series of focus groups with inpatients with a diagnosis of SMI, carers of people with a diagnosis of SMI and clinical staff will scope perceptions of attitudes, and practicalities of a pilot RCT. It is expected that between 6-8 people will attend each focus group.
Up to 5 focus groups will be conducted, lasting two hours each, addressed at the following populations: 1) Clinical staff affiliated with SLaM; 2) Inpatients with a diagnosis of SMI who reside at the Maudsley Hospital and the Bethlem Royal Hospital, and their carers; 3) Carers recruited via the national carers' forum, a carers group in SLaM.
Procedure: A series of simple open-ended questions will be asked, and participants will answer verbally. The questions will address factors relevant to the pilot study design including optimal duration and intensity of exercise sessions; location of exercise sessions; procedures surrounding storage of exercise equipment; and procedure surrounding outcome assessments. An audio-recording will record responses to these questions when permission has been granted. The qualitative data gained from the questions asked as part of the focus group will be analysed using thematic analysis to understand the main themes.
Stage Two:
Part a- A pilot RCT will be conducted whereby inpatients with a diagnosis of SMI will be randomly allocated to either 12 weeks of HIIT or 12 weeks of TAU. For patients in the HIIT arm, HIIT will be conducted twice a week for 12 weeks using a stationary bike. Each session will have the following structure: 4-minute warm-up, followed by 5X1 minute intervals at 85-95% of maximum heart rate, interspersed with active pauses of 90 seconds cycling at approximately 60-70% of maximum heart rate, and a 4-minute cool-down. Assessment measures including a neuropsychological test battery; fitness test; and physical health checks will be conducted at baseline, 6-, and 12-weeks. Twenty inpatients will be recruited to each arm of the RCT (40 inpatients in total). This number is based on recruiting a big-enough sample to assess the feasibility of the study and on the resources available (Leon, Davis \& Kraemer, 2011).
Pre-post intervention changes in will be measured, including changes in neuropsychological outcomes, fitness, physical health, and cardiovascular risk. A between-group analysis will also be conducted to see whether any changes in outcome differ from the control (TAU) group.
Part b- The RCT commenced in January 2020 using the above RCT procedure. Recruitment was halted in March 2020 at the start of the Covid-19 pandemic and HIIT sessions were ceased. The data gained will be analysed as above using an intention-to-treat basis.
In light of easing of lockdown the HIIT trial will resume using a remote cohort design. All eligible participants will receive HIIT, no randomisation will take place. A cohort design will be employed due to the smaller number of SMI patients receiving inpatient treatment during the outbreak/ slow resumption of inpatient admissions, thus it is unlikely that there will be enough numbers to randomise patients. The study primary and secondary outcomes remain the same.
HIIT sessions will resume remotely. This data will be analysed separately to existing data gathered from the RCT. A pre-post analysis on an ITT basis and a subgroup of those with 64% adherence will take place. The research team will conduct HIIT sessions remotely via a projector screen but a member of the ward will supervise sessions in person. Adverse events/ injuries/ difficulties will be observed by both the researcher remotely and the in-person staff member. Baseline and follow-up assessments will be conducted remotely via a projector screen/ telephone call for questionnaire measures.
A target of 6-8 patients will be recruited to the cohort study design.
Stage Three:
- Qualitative interviews: Participants who completed the pilot study will be invited to take part in individual semi-structured follow-up qualitative interviews. Feedback regarding the acceptability and feasibility of the study will be sought. Additionally, feedback will be sought from those that withdrew from the study and those that did not agree to take part. The interviews will assess 1) how participants experienced the intervention, 2) if there are any parts of the intervention that could be improved, and what factors influenced people in completing/not completing the intervention. Interviews will take place on a one-to-one basis with a member of the research team and a participant. Each qualitative interview will be conducted within 3 weeks of each participant finishing the HIIT pilot study/ within 3 weeks of drop-out if time commitments permit. Responses will be recorded when permission has been granted. Overall, each individual interview will take 30- 60 minutes and will not require participants to participate in any follow-up tasks. The qualitative data gained from these questions will be analysed using thematic analysis to understand the main themes.
- Focus groups:
Up to two focus groups with clinical staff at SLaM will be conducted and feedback regarding the acceptability and feasibility of the pilot HIIT study conducted in stage two of the research project will be sought. It is expected that between 6-8 people will attend each focus group. A series of simple open-ended questions will be asked, and participants will answer verbally. The questions will address staff's opinions regarding the acceptability and feasibility of conducting HIIT in a mental health setting. An audio-recording will record responses to these questions when permission has been granted. The qualitative data gained from these questions will be analysed using thematic analysis to understand the main themes. Overall, each focus group should take no more than 2 hours and will not require participants to participate in any follow-up tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Feasibility Randomized Controlled Trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | Other: High Intensity Interval Training (HIIT)50% of participants (inpatients with a diagnosis of severe mental illness) will be randomised to HIIT. HIIT will be conducted twice a week for 12 weeks using a stationary bike. Each session will have the following structure: 4-minute warm-up, followed by 5X1 minute intervals at 85-95% of maximum heart rate, interspersed with active pauses of 90 seconds cycling at approximately 60-70% of maximum heart rate, and a 4-minute cool-down. Each exercise session will take 19 minutes to complete (11 minutes of HIIT + warm-up and cool-down). However, the amount of HIIT will be adapted for people who may be unable to complete the above target and gradually build up until they can complete the recommended amount. All exercise sessions will be conducted in a 1:1 environment with a participant and a member of the research team who will supervise the exercise session. |
| Treatment As Usual (TAU) | No intervention | –50% of participants will be randomised to TAU. They will be provided with details of the local hospital gym availability and instructed to maintain their usual dietary habits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Capacity to provide informed consent.
- Aged ≥18 years.
- Either be: 1) Inpatients at SLaM with a diagnosis of SMI (Major Depressive Disorder, Bipolar disorder, Schizophrenia Spectrum Disorders, 2) Carers providing unpaid support to someone with a SMI, 3) Clinical staff at SLaM.
- Inpatients at SLaM with a diagnosis of SMI.
- Capacity to provide informed consent.
Key exclusion criteria (12 listed)
- Is aged <18 years old.
- Is aged <18 years old or >60 years old.
- Is pregnant.
- Has an eating disorder.
- Has a medical condition that impedes exercise, (as assessed via discussion with the patient's clinical team).
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 |
|---|---|---|
| High Intensity Interval Training (HIIT)HIIT is a type of exercise involving alternating short bursts of high intensity exercise with recovery periods of rest or light exercise. | Other | High Intensity Interval Training (HIIT) |
Primary outcome
Number of wards that agree to hosting the HIIT Pilot Study and number that do not agree to hosting the HIIT pilot study
Time frame: Through study completion, an average of 1 year
as assessed via a tally of acceptances and refusals
Number of people who consent to take part
Time frame: Through study completion, an average of 1 year
as assessed via a tally of acceptances and refusals
Average adherence to HIIT sessions and assessments
Time frame: Throughout length of participation in the HIIT trial, 12 weeks
as assessed via a record of number of HIIT sessions and number of assessments attended, and number of HIIT sessions and assessments not attended
Number of Participants With Treatment-Related Adverse Events
Time frame: Through study completion, an average of 1 year
as assessed via a tally of all medical effects observed and all medical effects reported by participants
16 secondary outcomes
BMI
Time frame: baseline, 6-weeks, 12-weeks
Weight
Time frame: baseline, 6-weeks, 12-weeks
Waist Circumference (WC)
Time frame: baseline, 6-weeks, 12-weeks
Systolic and diastolic blood pressure
Time frame: baseline, 6-weeks, 12-weeks
Maximal oxygen uptake (VO2max)
Time frame: baseline, 6-weeks, 12-weeks
Gait speed
Time frame: baseline, 6-weeks, 12-weeks
Change in Montreal Cognitive Assessment (MoCA) score
Time frame: baseline, 6-weeks, 12-weeks
Change in global assessment of functioning scale (GAF) score
Time frame: baseline, 6-weeks, 12-weeks
Change in Brief Psychiatric Rating Scale (BPRS) score
Time frame: baseline, 6-weeks, 12-weeks
Change in the brief insomnia severity index (ISI)
Time frame: baseline, 6-weeks, 12-weeks
Cigarette intake
Time frame: baseline, 6-weeks, 12-weeks
Change in Depression Anxiety Stress Scale short version (DASS21) score
Time frame: baseline, before and after the first HIIT session (or before and after 19 minutes of rest for the TAU arm), 6-weeks, 12-weeks
Change in the Rosenberg Self-Esteem Scale (RSES) score
Time frame: baseline, 6-weeks, 12-weeks
Change in the International Physical Activity Questionnaire (IPAQ) score
Time frame: baseline, 6-weeks, 12-weeks
Change in the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) score
Time frame: baseline, 6-weeks, 12-weeks
Change in the Short Warwick Edinburgh Mental Well-being Scale (WEMWBS) score
Time frame: baseline, 6-weeks, 12-weeks
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 7 Mar 2022.
- Background: PubMed 21035130Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.
- Background: PubMed 21379357DE Hert M, Correll CU, Bobes J, Cetkovich-Bakmas M, Cohen D, Asai I, Detraux J, Gautam S, Moller HJ, Ndetei DM, Newcomer JW, Uwakwe R, Leucht S. Physical illness in patients with severe mental disorders. I. Prevalence, impact of medications and disparities in health care. World Psychiatry. 2011 Feb;10(1):52-77. doi: 10.1002/j.2051-5545.2011.tb00014.x.
- Background: PubMed 19682863De Hert M, Dekker JM, Wood D, Kahl KG, Holt RI, Moller HJ. Cardiovascular disease and diabetes in people with severe mental illness position statement from the European Psychiatric Association (EPA), supported by the European Association for the Study of Diabetes (EASD) and the European Society of Cardiology (ESC). Eur Psychiatry. 2009 Sep;24(6):412-24. doi: 10.1016/j.eurpsy.2009.01.005. Epub 2009 Aug 13.
- Background: PubMed 16338246Hennekens CH, Hennekens AR, Hollar D, Casey DE. Schizophrenia and increased risks of cardiovascular disease. Am Heart J. 2005 Dec;150(6):1115-21. doi: 10.1016/j.ahj.2005.02.007.
- Background: PubMed 19595447Tiihonen J, Lonnqvist J, Wahlbeck K, Klaukka T, Niskanen L, Tanskanen A, Haukka J. 11-year follow-up of mortality in patients with schizophrenia: a population-based cohort study (FIN11 study). Lancet. 2009 Aug 22;374(9690):620-7. doi: 10.1016/S0140-6736(09)60742-X.
- Background: PubMed 24144531Weston KS, Wisloff U, Coombes JS. High-intensity interval training in patients with lifestyle-induced cardiometabolic disease: a systematic review and meta-analysis. Br J Sports Med. 2014 Aug;48(16):1227-34. doi: 10.1136/bjsports-2013-092576. Epub 2013 Oct 21.
- Derived from this study: PubMed 34749822Martland R, Onwumere J, Stubbs B, Gaughran F. Study protocol for a pilot high-intensity interval training intervention in inpatient mental health settings: a two-part study using a randomised controlled trial and naturalistic study design. Pilot Feasibility Stud. 2021 Nov 8;7(1):198. doi: 10.1186/s40814-021-00937-6.
- 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.
Brendon Stubbs principal investigator
King's College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training (HIIT) in people with Major Depressive Disorder and Bipolar Disorder, run by King's College London at 2 sites 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 13 inclusion and 12 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 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of wards that agree to hosting the HIIT Pilot Study and number that do not agree to hosting the HIIT pilot study (time frame: Through study completion, an average of 1 year). 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?
On the ClinicalTrials.gov record for NCT03959735, which also lists 7 linked publications.
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 7 Mar 2022.