"Is the Use of High Intensity Interval Training (HIIT) Feasible and Acceptable Amongst Inpatients With Severe Mental Illness (SMI)?" A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Number of wards that agree to hosting the HIIT Pilot Study and number that do not agree to hosting the HIIT pilot study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
- •Ready to exercise according to the Physical Activity Readiness Questionnaire.
- •Stage 3 (Follow-up): Qualitative interview:
- •inpatients who were eligible for stage
- •Stage 3 (Follow-up): Focus group:
- •staff who participated in stage 1.
排除标准
- •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.
结局指标
主要结局
Number of wards that agree to hosting the HIIT Pilot Study and number that do not agree to hosting the HIIT pilot study
时间窗: 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
时间窗: Through study completion, an average of 1 year
as assessed via a tally of acceptances and refusals
Average adherence to HIIT sessions and assessments
时间窗: 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
时间窗: 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
次要结局
- Weight(baseline, 6-weeks, 12-weeks)
- Change in Montreal Cognitive Assessment (MoCA) score(baseline, 6-weeks, 12-weeks)
- Change in global assessment of functioning scale (GAF) score(baseline, 6-weeks, 12-weeks)
- Change in Brief Psychiatric Rating Scale (BPRS) score(baseline, 6-weeks, 12-weeks)
- Systolic and diastolic blood pressure(baseline, 6-weeks, 12-weeks)
- Waist Circumference (WC)(baseline, 6-weeks, 12-weeks)
- Maximal oxygen uptake (VO2max)(baseline, 6-weeks, 12-weeks)
- Gait speed(baseline, 6-weeks, 12-weeks)
- Change in the brief insomnia severity index (ISI)(baseline, 6-weeks, 12-weeks)
- BMI(baseline, 6-weeks, 12-weeks)
- Cigarette intake(baseline, 6-weeks, 12-weeks)
- Change in Depression Anxiety Stress Scale short version (DASS21) score(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(baseline, 6-weeks, 12-weeks)
- Change in the International Physical Activity Questionnaire (IPAQ) score(baseline, 6-weeks, 12-weeks)
- Change in the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) score(baseline, 6-weeks, 12-weeks)
- Change in the Short Warwick Edinburgh Mental Well-being Scale (WEMWBS) score(baseline, 6-weeks, 12-weeks)