Abstract
BackgroundSevere mental illnesses (SMI), including schizophrenia spectrum disorder, bipolar disorder and major depressive disorder, are associated with physical health comorbidities and premature mortality. Physical activity and structured exercise have a beneficial impact on cardiometabolic risk and ameliorate mental health symptomology and cognition. This protocol describes a feasibility study for a high-intensity interval training (HIIT) intervention among inpatients with SMI, to improve their physical and mental health.MethodsThe feasibility study follows a two-part design owing to COVID-19-related adaptations to project design: (a) a non-blinded randomised controlled trial (RCT) of 12 weeks of bicycle-based HIIT, delivered twice weekly in a face-to-face, one-to-one setting, compared to treatment as usual (TAU) and (b) a naturalistic study of inpatient HIIT; eligible participants will be invited to two sessions of HIIT per week, delivered by the research team remotely or in person. Additionally, participants in the naturalistic study may use the bike to conduct self-directed sessions of their chosen length and intensity. We will measure the feasibility and acceptability of the HIIT intervention as primary outcomes, alongside secondary and tertiary outcomes evaluating the physical, mental and cognitive effects of HIIT. The study aims to recruit 40 patients to the RCT and 6–8 patients to the naturalistic design.DiscussionExercise is a modifiable lifestyle barrier that can reverse cardiometabolic disease risk. If HIIT is found to be feasible and acceptable in inpatients with SMI, there would be scope for large-scale work to evaluate the clinical, cost and implementation effectiveness of HIIT in inpatient mental health settings.Trial registrationClinicalTrials.gov NCT03959735. Registered June 22, 2019.
Highlights
Severe mental illnesses (SMI), including schizophrenia spectrum disorder, bipolar disorder and major depressive disorder, are associated with physical health comorbidities and premature mortality
The primary aim of this feasibility study is to determine whether high-intensity interval training (HIIT) is acceptable and feasible to implement in a psychiatric inpatient setting with patients with a broad range of severe mental illnesses, while the secondary aim is to investigate if the HIIT intervention improves mental health symptoms, including psychiatric symptoms, depression, anxiety, stress, sleep and mental wellbeing; cognition; and along with physical activity measures including increases in weekly physical activity, motivation to engage in exercise and anthropometric measures
Criteria that indicate that a future effectiveness trial is feasible include (1) a majority of wards agreeing to hosting the project, (2) meeting stated recruitment (40 participants to the randomised controlled trial (RCT) and 10 participants to the naturalistic study phase), (3) comparable completion rates and adherence to other exercise interventions carried out in people with SMI (drop-out rates of previous exercise interventions in people with SMI has averaged 24–32.5% and adherence to scheduled sessions has averaged 55–94% [41, 42, 83], (4) lack of serious exercise-related adverse events (AE) and (5) participants expressing that the conduct of the intervention was acceptable
Summary
The feasibility study follows a two-part design owing to COVID-19-related adaptations to project design: (a) a non-blinded randomised controlled trial (RCT) of 12 weeks of bicycle-based HIIT, delivered twice weekly in a face-to-face, one-to-one setting, compared to treatment as usual (TAU) and (b) a naturalistic study of inpatient HIIT; eligible participants will be invited to two sessions of HIIT per week, delivered by the research team remotely or in person. Participants in the naturalistic study may use the bike to conduct self-directed sessions of their chosen length and intensity. We will measure the feasibility and acceptability of the HIIT intervention as primary outcomes, alongside secondary and tertiary outcomes evaluating the physical, mental and cognitive effects of HIIT. The study aims to recruit 40 patients to the RCT and 6–8 patients to the naturalistic design
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