Mental Health and Vigorous-intensity Physical Activity

Mental Health Issue Clinical Trial

— +MoveMENT  

Official title:

Mental Health and Vigorous Physical Activity: Effectiveness Study on the Improvement of Physical Health, Mental Health and Quality of Life by Combining HIIT and VILPA With People With Severe Mental Disorder (+MoveMENT)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06338917
• Other study ID #: File 2022 DI 61
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 10, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: March 2024
• Source: University of Vic - Central University of Catalonia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

People with severe mental illness have unhealthy lifestyles and habits, such as sedentary behavior and physical inactivity. Which are associated with a higher prevalence of premature mortality and chronic comorbidities.

The aim of this study is to evaluate the efficacy of a physical activity program, which pretends to increase the number of vigorous-intensity physical activity bouts in their daily life, as a habit, combining High Intensity Interval Training (HIIT) and Vigorous Intensity Life-Style Physical Activity (VILPA). Secondary aims are to evaluate the efficacy of the program on fitness, physical activity and sedentary behavior level and patron; depressive, mania and psychotic symptomatology, functionality and cognitive functioning; quality of life and mood.

Description:

Multi-centric, controlled clinical trial. Data will be collected from recuperation services from Central Catalonia. A sample size of 60 people will be allocated into a control group (n=30) or intervention group (n=30), with post-intervention follow-up at 7 and 13 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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Other:
• Vigorous-intensity physical activity program
The intervention group will participate in a vigorous-intensity physical activity program which pretends to increase the number of physical activity daily bouts that people with severe mental illness practice. The main aim is to achieve the basic physical activity practice guidelines of World Health Organization, which means achieve to do 75-150 minutes per week of moderate-to-high intensity physical activity.

Locations

Country	Name	City	State
Spain	University of Vic	Vic	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
University of Vic - Central University of Catalonia	AGAUR, IRIS-CC

Country where clinical trial is conducted

Spain, 

References & Publications (53)

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* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective perception of joy	Health Improvement Rating Scale (PROM). Scale of perception of health improvement after participating in a physical activity program. It is valued from 0 to 5 (0 never and 5 always).	Measurement will be at the final of the intervention, at 12 follow-up months.
Other	Subjective perception of calm	Health Improvement Rating Scale (PROM). Scale of perception of health improvement after participating in a physical activity program. It is valued from 0 to 5 (0 never and 5 always).	Measurement will be at the final of the intervention, at 12 follow-up months.
Other	Subjective perception of energy	Health Improvement Rating Scale (PROM). Scale of perception of health improvement after participating in a physical activity program. It is valued from 0 to 5 (0 never and 5 always).	Measurement will be at the final of the intervention, at 12 follow-up months.
Other	Subjective perception of time spent	Rating scale of the treatment received during treatment (PREM). Scale of perception of the treatment received during treatment, after participating in a physical activity program. It is valued from 0 to 5 (0 never and 5 always).	Measurement will be at the final of the intervention, at 12 follow-up months.
Other	Subjective perception of the received information	Rating scale of the treatment received during treatment (PREM). Scale of perception of the treatment received during treatment, after participating in a physical activity program. It is valued from 0 to 5 (0 never and 5 always).	Measurement will be at the final of the intervention, at 12 follow-up months.
Other	Subjective perception of respect received	Rating scale of the treatment received during treatment (PREM). Scale of perception of the treatment received during treatment, after participating in a physical activity program. It is valued from 0 to 5 (0 never and 5 always).	Measurement will be at the final of the intervention, at 12 follow-up months.
Primary	Psychotic symptomatology	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.	Measurement will be at the beginning, 7 and 12 follow-up months.
Primary	Depression symptomatology	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.	Measurement will be at the beginning, 7 and 12 follow-up months.
Primary	Depression severity	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.	Measurement will be at the beginning, 7 and 12 follow-up months.
Primary	Mania symptomatology	The Young Mania Rating Scale (YMRS) it is a rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. The final score it gets through the suma of all the items. A score bellow 12 it means remission, from 13-19 minimal symptoms, from 20-25 mild mania, 26-37 moderate mania and 38-60 severe mania.	Measurement will be at the beginning, 7 and 12 follow-up months.
Primary	Mania severity	The Young Mania Rating Scale (YMRS) it is a rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. The final score it gets through the suma of all the items. A score bellow 12 it means remission, from 13-19 minimal symptoms, from 20-25 mild mania, 26-37 moderate mania and 38-60 severe mania.	Measurement will be at the beginning, 7 and 12 follow-up months.
Primary	Disability	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.	Measurement will be at the beginning, 7 and 12 follow-up months.
Primary	Quality of life	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.	Measurement will be at the beginning, 2, 4, 7 and 12 follow-up months.
Primary	Cognitive functioning	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.	Measurement will be at the beginning, 7 and 12 follow-up months.
Primary	Mood	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".	Measurement will be at the beginning, 2, 4, 7 and 12 follow-up months.
Secondary	Subjective physical activity patron	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.	Measurement will be at the beginning, 2, 4, 7 and 12 follow-up months.
Secondary	Subjective sedentary behaviour patron	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.	Measurement will be at the beginning, 2, 4, 7 and 12 follow-up months.
Secondary	Perception of physical fitness	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.	Measurement will be at the beginning, 2, 4, 7 and 12 follow-up months.
Secondary	Objective physical activity patron	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).	Measurement will be at the beginning, 4, 7 and 12 follow-up months.
Secondary	Objective sedentary behavior patron	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).	Measurement will be at the beginning, 4, 7 and 12 follow-up months.
Secondary	Cardiorespiratory endurance	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.	Measurement will be at the beginning, 4, 7 and 12 follow-up months.
Secondary	Velocity	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.	Measurement will be at the beginning, 4, 7 and 12 follow-up months.
Secondary	Agility	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.	Measurement will be at the beginning, 4, 7 and 12 follow-up months.
Secondary	Lower limb strength	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.	Measurement will be at the beginning, 4, 7 and 12 follow-up months.