Mental Health and Vigorous-intensity Physical Activity
- Conditions
- Mental Health Issue
- Interventions
- Other: Vigorous-intensity physical activity program
- Registration Number
- NCT06338917
- Lead Sponsor
- University of Vic - Central University of Catalonia
- Brief Summary
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 main objective of this protocol is to evaluate the impact of a moderate-to-vigorous physical activity program on improving clinical, functional and personal recovery outcomes in order to seek for a diverse array of improvements in mental, physical health, quality of life and functioning in people who have severe mental illness
- Detailed Description
Multi-centric, controlled clinical trial. Data will be collected from recuperation services from Central Catalonia. A sample size of 80 people will be allocated into a control group (n=40) or intervention group (n=40), with post-intervention follow-up at 7 and 10 months. Professionals from recuperation services will explain the physical activity program to everyone included, and they will invite them to participate through a specific interview guide. The control group will receive usual healthcare from their recuperation service. The intervention group will participate in a 7-month vigorous-intensity physical activity program which pretends to increase the number of physical activity daily bouts.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Severe mental illness diagnosis, according to the 5th edition of the diagnostic and statistical manual of mental disorders (DSM-5)
- Volunteers to engage in a physical activity program.
- Decompensation of the underlying disorder
- Have absolute contraindications due to the practice of physical exercise
- Have lack of understanding of the Catalan or Spanish language.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Vigorous-intensity physical activity program Participation in a vigorous-intensity physical activity program
- Primary Outcome Measures
Name Time Method Disability 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.
Mood Measurement will be at the beginning and during all the physical activity sessions. Visual analogue subjective mood scale (VAS). A visual scale designed to determine subjective mood state, which can be rated from 0 to 10, with 0 being "I feel worse than ever" and 10 being "I feel better than ever".
Quality of life Measurement will be at the beginning, 2, 4, 7 and 10 follow-up months. The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health with regard to the respective domain. Thus, the patient's physical, psychological, social, and environmental state of health are assessed separately.
Cognitive functioning Measurement will be at the beginning, 4 and 7 follow-up 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 Measurement will be at the beginning, 4 and 7 follow-up 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 Measurement will be at the beginning, 4 and 7 follow-up 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.
- Secondary Outcome Measures
Name Time Method Objective physical activity patron Measurement will be at the beginning, 4 and 7 follow-up months. To measure objective physical activity and sedentary behavior, the activPAL3TM will be used. This is a miniature electronic logger designed to quantify daily free-living activities. With the activPAL3TM you can obtain a record of total sitting time, number of sitting time interruptions, sedentary bouts, standing time and activity time (light, moderate and vigorous-intensity).
Objective sedentary behavior patron Measurement will be at the beginning, 4 and 7 follow-up months. To measure objective physical activity and sedentary behavior, the activPAL3TM will be used. This is a miniature electronic logger designed to quantify daily free-living activities. With the activPAL3TM you can obtain a record of total sitting time, number of sitting time interruptions, sedentary bouts, standing time and activity time (light, moderate and vigorous-intensity).
Perception of physical fitness Measurement will be at the beginning, 2, 4, 7 and 10 follow-up months. The International Fitness Scale (IFIS) evaluates people's perception of physical fitness. It is a 5-item scale (general fitness, cardio-respiratory, muscular strength, speed and agility, and flexibility) rated from 1 to 5, with 1 being "very bad" and 5 being "very good". The final result is obtained from the sum total of the items, with the highest score being 25. The higher the final result, the better the perception.
Subjective physical activity patron Measurement will be at the beginning, 2, 4, 7 and 10 follow-up months. International Physical Activity Questionnaire, short and Spanish version, (IPAQ-SF17). A 7-question scale that assesses habitual physical activity (minutes/week) performed in the last 7 days. It measures physical activity performed at different intensities: vigorous, moderate and light physical activity. The total physical activity (minutes/week) is obtained from the sum total of the minutes/week of physical activity performed at the different intensities.
Subjective sedentary behaviour patron Measurement will be at the beginning, 2, 4, 7 and 10 follow-up months. Sedentary Behavior Questionnaire, Spanish version (SBQ). Scale of 22 items, divided into two blocks: weekdays and weekends. The scale identifies the hours/day spent sitting, stretching or reclining during the day before doing the following activities: watching TV, playing PC/video games, eating, resting while lying down, sitting in a vehicle, doing office work, relaxing (e.g. reading or listening to music). The total daily hours of sedentary behaviour are obtained by adding the hours/day spent in each of the above activities. Total daily hours are obtained for both weekdays and weekends.
Cardiorespiratory endurance Measurement will be at the beginning, 4, and 7 follow-up months. The 6-minute walk test is a test in which the person walks at his or her normal pace for 6 minutes. Every minute the person is asked how fatigued he/she is (with the Borg Fatigue Scale). The more meters the person walks, the better the cardio-respiratory condition.
Agility Measurement will be at the beginning, 4 and 7 follow-up months. The T-test is a test in which the person has to do a T-shaped circuit as fast as possible, combining forward, backward and sideways movements. When evaluating the test, the speed of execution is taken into account, as well as the correct execution of the movements.
Lower limb strength Measurement will be at the beginning, 4 and 7 follow-up months. The sit-to-stand test is a test in which the person has to stand up and sit down on a chair 5 times in a row as fast as possible. The faster the person is able to do the repetitions, the better the evaluation of the test.
Trial Locations
- Locations (1)
University of Vic
🇪🇸Vic, Barcelona, Spain