High Intensity Interval Training in Severe Mental Illness

Schizophrenia Clinical Trial

Official title:

"Is the Use of High Intensity Interval Training (HIIT) Feasible and Acceptable Amongst Inpatients With Severe Mental Illness (SMI)?" A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03959735
• Other study ID #: IRAS263996
• Status: Completed
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: August 30, 2021

Study information

• Verified date: September 2020
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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., 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.

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:

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

• 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.

Exclusion Criteria:

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.

• 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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mental Disorders
• Schizophrenia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	Bethlem Royal Hospital, South London and maudsley NHS Trust	London
United Kingdom	Maudsley Hospital, South London and Maudsley NHS Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
King's College London	National Institute for Health Research, United Kingdom, South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

DE Hert M, Correll CU, Bobes J, Cetkovich-Bakmas M, Cohen D, Asai I, Detraux J, Gautam S, Möller 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. — View Citation

De Hert M, Dekker JM, Wood D, Kahl KG, Holt RI, Möller 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. — View Citation

Hennekens CH, Hennekens AR, Hollar D, Casey DE. Schizophrenia and increased risks of cardiovascular disease. Am Heart J. 2005 Dec;150(6):1115-21. Review. — View Citation

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. — View Citation

Tiihonen J, Lönnqvist 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. — View Citation

Weston KS, Wisløff 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Appetite cravings	Participants will be asked: 'On a scale of 0-10 how much do you feel like smoking?' (0 will indicate no craving and 10 will indicate a craving)	before and after the first HIIT session (or before and after 19 minutes of rest for the TAU arm
Other	Cigarette cravings	Participants will be asked: 'On a scale of 0-10 how much do you feel like eating a snack right now? And if you do feel like eating what would it be?' (0 will indicate no craving and 10 will indicate a craving)	before and after the first HIIT session (or before and after 19 minutes of rest for the TAU arm
Other	Change in Subjective Exercise Experiences Scale (SEES) score	This questionnaire contains 12-items subdivided into three subscales to assess immediate feelings of positive well-being, psychological distress and fatigue. Each subscale contains the scores from 4-items rated on a 7-point Likert scale. Higher scores for each subscale indicated higher perceptions of positive well-being, psychological distress and fatigue respectively.	before and after the first HIIT session (or before and after 19 minutes of rest for the TAU arm
Primary	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	Through study completion, an average of 1 year
Primary	Number of people who consent to take part	as assessed via a tally of acceptances and refusals	Through study completion, an average of 1 year
Primary	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	Throughout length of participation in the HIIT trial, 12 weeks
Primary	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	Through study completion, an average of 1 year
Secondary	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.	baseline, 6-weeks, 12-weeks
Secondary	Weight	Weight will be measured in Kg using household scales. The investigators will assess whether weight decreases after participation in the HIIT trial.	baseline, 6-weeks, 12-weeks
Secondary	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.	baseline, 6-weeks, 12-weeks
Secondary	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.	baseline, 6-weeks, 12-weeks
Secondary	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.	baseline, 6-weeks, 12-weeks
Secondary	Gait speed	The investigators will measure time taken to walk 6 meters. Longer times indicate reduced physical fitness.	baseline, 6-weeks, 12-weeks
Secondary	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.	baseline, 6-weeks, 12-weeks
Secondary	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.	baseline, 6-weeks, 12-weeks
Secondary	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.	baseline, 6-weeks, 12-weeks
Secondary	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.	baseline, 6-weeks, 12-weeks
Secondary	Cigarette intake	Participants will be asked how many cigarettes they smoke on a typical day.	baseline, 6-weeks, 12-weeks
Secondary	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.	baseline, before and after the first HIIT session (or before and after 19 minutes of rest for the TAU arm), 6-weeks, 12-weeks
Secondary	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.	baseline, 6-weeks, 12-weeks
Secondary	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.	baseline, 6-weeks, 12-weeks
Secondary	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.	baseline, 6-weeks, 12-weeks
Secondary	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.	baseline, 6-weeks, 12-weeks