Clinical trial NCT06338917: Mental Health and Vigorous-intensity Physical Activity
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 Illness (+MoviMENT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Issue
Keywords: Vigorous-intensity
Physical activity
Fitness
Sedentary behavior
Severe mental illness
Mental health rehabilitation services
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
Collaborators: name: IRIS-CC
name: AGAUR
First posted: 2024-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disability
timeFrame: Measurement will be at the beginning, 4, 7 and 10 follow-up months.
measure: Mood
timeFrame: Measurement will be at the beginning and during all the physical activity sessions.
measure: Quality of life
timeFrame: Measurement will be at the beginning, 2, 4, 7 and 10 follow-up months.
measure: Cognitive functioning
timeFrame: Measurement will be at the beginning, 4 and 7 follow-up months.
measure: Psychotic symptomatology
timeFrame: Measurement will be at the beginning, 4 and 7 follow-up months.
measure: Depression symptomatology
timeFrame: Measurement will be at the beginning, 4 and 7 follow-up months.
Secondary outcomes:
measure: Objective physical activity patron
timeFrame: Measurement will be at the beginning, 4 and 7 follow-up months.
measure: Objective sedentary behavior patron
timeFrame: Measurement will be at the beginning, 4 and 7 follow-up months.
measure: Perception of physical fitness
timeFrame: Measurement will be at the beginning, 2, 4, 7 and 10 follow-up months.
measure: Subjective physical activity patron
timeFrame: Measurement will be at the beginning, 2, 4, 7 and 10 follow-up months.
measure: Subjective sedentary behaviour patron
timeFrame: Measurement will be at the beginning, 2, 4, 7 and 10 follow-up months.
measure: Cardiorespiratory endurance
timeFrame: Measurement will be at the beginning, 4, and 7 follow-up months.
measure: Agility
timeFrame: Measurement will be at the beginning, 4 and 7 follow-up months.
measure: Lower limb strength
timeFrame: Measurement will be at the beginning, 4 and 7 follow-up months.
Other outcomes:
measure: Patient Reported Experience Measures (PREM) and Patient Reported Outcome Measures (PROM)
timeFrame: Measurement will be at the final of the intervention, at 7 follow-up months.
Locations:
city: Vic
country: Spain
facility: University of Vic
state: Barcelona
Study officials:
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