scholarly journals 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

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Rebecca Martland ◽  
Juliana Onwumere ◽  
Brendon Stubbs ◽  
Fiona Gaughran

Abstract Background Severe 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. Methods 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. 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. Discussion Exercise 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 registration ClinicalTrials.gov NCT03959735. Registered June 22, 2019.

2021 ◽  
Author(s):  
Rebecca Martland ◽  
Juliana Onwumere ◽  
Brendon Stubbs ◽  
Fiona Gaughran

Abstract Background: Severe 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 amongst inpatients with SMI, to improve their physical and mental health. Methods: The feasibility study follows a two-part design owing to Covid-19 related adaptations to project design: a) A non-blinded randomized 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). 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 may use the bike to conduct self-directed sessions of their chosen length and intensity. We will measure 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. Discussion: Exercise 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 registration: ClinicalTrials.gov, registration no: NCT03959735, registered 22/05/2019, https://clinicaltrials.gov/ct2/show/NCT03959735


BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034733 ◽  
Author(s):  
Ida Almenning Kiel ◽  
Sofie Lionett ◽  
Evelyn Bridget Parr ◽  
Helen Jones ◽  
Maria Aurora Hernandez Røset ◽  
...  

IntroductionPolycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age and the leading cause of anovulatory infertility. Women with PCOS have a 15-fold higher prevalence of infertility, compared with women without PCOS, independent of body mass index (BMI). A healthy lifestyle is recommended to improve overall health and fertility in PCOS but there is limited evidence on the isolated effects of exercise, especially for reproductive outcomes. Previous findings indicate superior metabolic health benefits after vigorous compared with moderate-intensity exercise. Our primary aim is to determine the effect of high-intensity interval training (HIT) on menstrual frequency, as a proxy of reproductive function, in women with PCOS.Methods and analysisThe study is a two-centre, randomised, controlled trial with three parallel groups. Women (n=64) from Trondheim (Norway) and Melbourne (Australia) with PCOS according to the Rotterdam criteria will be randomly allocated (1:1:1) to high-volume HIT, low-volume HIT or a control group with no exercise after stratifying for BMI < or ≥ 27 kg/m2and study centre. Measurements for study end points will be undertaken at baseline, after a 16 week exercise intervention and at 12 months following baseline assessments. The primary outcome measure is menstruation frequency, measured as the number of self-reported menstrual bleedings divided by the number of expected menstrual bleedings during a 12-month period. Secondary outcome measurements include markers of cardiovascular, metabolic and reproductive health, as well as quality of life and adherence to and enjoyment of exercise.Ethics and disseminationThe Regional Committee Medical Research Ethics, Norway, and The Australian Catholic University Human Research Ethics Committee, Australia, have approved the trial protocol. This trial will provide new insight regarding the impact of exercise on fertility in PCOS. We expect this trial to contribute to new therapeutic exercise strategies as part of clinical care for women with PCOS.Trial registration numberClinical trial govNCT02419482.


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