Moderate-to-Vigorous Intensity Physical Activity as a Tool for Severe Mental Illness Recuperation Process: Study Protocol for a Pragmatic Controlled Clinical Trial (+moviMENT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Disability
研究概览
简要总结
Twenty-five percent of the population worldwide will experience a severe mental illness during their lifetime (World Health Organization, 2017). These people present strong barriers to adhering to moderate and vigorous-intensity continuous training. It is fundamental to overcome these barriers for practicing moderate-to-vigorous physical activity by adding behavioural change techniques into physical activity interventions (Maurus et al., 2023), in order to design and implement sustainable interventions that empower people to engage in it.
The overall aims will be to evaluate the efficacy of +moviMENT, a 28-week intervention program, designed to increase MVPA time in patients with SMI, and to assess the effects of the program on a range of indicators, in comparison with a 'usual care' control group.
详细描述
This is a pragmatic controlled clinical trial with intervention and control group, in which patients will be recruited from two different services from different cities. Patients who will meet the inclusion criteria (>16 years, severe mental illness diagnosis, not medical risk to practice MVPA, living in the community) from one service will be assigned to the intervention and those from the other to the control group. The intervention comprises 16 weeks of group based High Intensity Interval Training (HIIT), with transition to individual community based Vigorous Intermittent Lifestyle Physical Activity (VILPA) over the next 12 weeks - for a total intervention period of 28 weeks. Primary outcomes measures (clinical and functional) and secondary (personal recovery, self-perception and device-measured fitness, physical activity and sedentary behaviour and experience) will be assessed at baseline and after 16, 28 and 40 weeks, after follow-up. Group differences in change scores will be assessed using linear mixed-effects models with time, group, and their interaction as fixed effects, accounting for within-subject correlations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participants in both groups are not aware of the existence of the other group. The health provider in the control group is aware of the existence of the intervention group but does not know which intervention is being carried out.
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients (non-hospitalised) registered in one of two mental health services.
- •SMI diagnosis, according to the 5th edition of the 5th Diagnostic and Statistical Manual of mental disorders (DSM-5) [52].
- •Living in the community
- •Not having any contraindications or medical risk to MVPA.
- •Age 18 to 69 years.
- •Willing and able to provide informed consent.
排除标准
- 未提供
结局指标
主要结局
Disability
时间窗: Measurement will be at the beginning, 4, 7 and 10 follow-up months.
World Health Organization-Disability Assessment Schedule II (WHODAS 2.0): Scale that assesses the activity limitations and participation restrictions experienced by the person. Through its 36 items, the WHODAS II allows us to obtain, both at a specific and general level, a measure of the severity and duration of the disability that results from the "health conditions" of people, also providing information on the "costs" that they generate in the individual, in the family or in society.
Cognitive functioning
时间窗: Measurement will be at the beginning, 4 and 7 months.
Screen for Cognitive Impairment in Psychiatry (SCIP-S): This scale is designed to assess cognitive deficits in psychiatric patients. It consists of 5 subtests that assess immediate and delayed verbal learning, working memory, verbal fluency and processing speed. The total score is the sum of the 5 subscales and its interpretation allows detecting the presence of cognitive deficit; a higher score corresponds to better cognitive performance.
Psychotic symptomatology
时间窗: Measurement will be at the beginning, 4 and 7 months.
The Brief Psychiatric Rating Scale (BPRS) is a rating scale which a clinician or researcher may use to measure psychiatric symptoms such as depression, anxiety, hallucinations, psychosis and unusual behaviour. It has 18 items. The rater enters a number for each symptom construct that ranges from 1 (not present) to 7 (extremely severe). It is scored by adding together the scores from the individual items, with higher scores indicating more severe symptoms.
Depression symptomatology
时间窗: Measurement will be at the beginning, 4 and 7 months.
Hamilton Depression Rating Scale (HAM-D): A 17-item mood rating scale. A score below 7 is considered to indicate no depressed mood, a score between 8 and 16 is considered to be moderate depression and a score above 18 indicates severe depression.
次要结局
- Device-measured physical activity and sedentary behaviour pattern(Measurement will be at the beginning, 4 and 7 months.)
- Fitness self-perception(Measurement will be at the beginning, 4, 7 and 10 follow-up months.)
- Quality of life self-perception(Measurement will be at the beginning, 4, 7 and 10 follow-up months.)
- Physical activity pattern self-perception(Measurement will be at the beginning, 4, 7 and 10 follow-up months.)
- Sedentary behaviour pattern self-perception(Measurement will be at the beginning, 4, 7 and 10 follow-up months.)
- Cardiorespiratory endurance(Measurement will be at the beginning, 4 and 7 months.)
- Agility(Measurement will be at the beginning, 4 and 7 months.)
- Lower limb strength(Measurement will be at the beginning, 4 and 7 months.)
研究者
Mariona Caro Crous
MsC in physical activity and health and graduate in physical activity and sport science
University of Vic - Central University of Catalonia