High Intensity Interval Training in Severe Mental Illness

NCT03959735 | Completed DMC

• 1 other identifier: IRAS263996
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Major Depressive Disorder; Bipolar Disorder; Schizophrenia

Keywords

inpatients

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (16)

• BMI

  baseline, 6-weeks, 12-weeks

• Weight

  baseline, 6-weeks, 12-weeks

• Waist Circumference (WC)

  baseline, 6-weeks, 12-weeks

• Systolic and diastolic blood pressure

  baseline, 6-weeks, 12-weeks

• Maximal oxygen uptake (VO2max)

  baseline, 6-weeks, 12-weeks

Other Outcomes (3)

• Appetite cravings

  before and after the first HIIT session (or before and after 19 minutes of rest for the TAU arm

• Cigarette cravings

  before and after the first HIIT session (or before and after 19 minutes of rest for the TAU arm

• Change in Subjective Exercise Experiences Scale (SEES) score

  before and after the first HIIT session (or before and after 19 minutes of rest for the TAU arm

Study Arms (2)

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.

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

Interventions

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.

High Intensity Interval Training (HIIT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• National Institute for Health Research, United Kingdom: collaborator
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (2)

Bethlem Royal Hospital, South London and maudsley NHS Trust

London, BR3 3BX, United Kingdom

Location

Maudsley Hospital, South London and Maudsley NHS Trust

London, SE5 8AZ, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 21035130 BACKGROUND

• DE 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.

  PMID: 21379357 BACKGROUND

• De 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.

  PMID: 19682863 BACKGROUND

• Hennekens 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.

  PMID: 16338246 BACKGROUND

• Tiihonen 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.

  PMID: 19595447 BACKGROUND

• Weston 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.

  PMID: 24144531 BACKGROUND

• Martland 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.

  PMID: 34749822 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Schizophrenia

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Brendon Stubbs

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility Randomized Controlled Trial (RCT)

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 22, 2019
• Study Start: October 10, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: March 7, 2022

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)