Moderate-to-Vigorous Intensity Physical Activity and Severe Mental Illness
NCT ID: NCT06338917
Last Updated: 2025-09-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-06-01
Study Completion Date
2026-01-31
Brief Summary
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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.
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.
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Detailed Description
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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.
Conditions
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Mental Health Issue
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
OTHER
Blinding Strategy
DOUBLE
Participants
Caregivers
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.
Study Groups
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Intervention group
Participation in a moderate-to-vigorous intensity physical activity program a part from the usual health care treatment
Group Type
EXPERIMENTAL
Moderate-to-vigorous intensity physical activity program (+moviMENT)
Intervention Type
BEHAVIORAL
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.
Control group
Following the usual health care treatment
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Moderate-to-vigorous intensity physical activity program (+moviMENT)
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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
69 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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IRIS-CC
UNKNOWN
Sponsor Role
collaborator
AGAUR
UNKNOWN
Sponsor Role
collaborator
University of Vic - Central University of Catalonia
OTHER
Sponsor Role
lead
Responsible Party
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Mariona Caro Crous
MsC in physical activity and health and graduate in physical activity and sport science
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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University of Vic
Vic, Barcelona, Spain
Site Status
Countries
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Spain
References
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Other Identifiers
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File 2022 DI 61
Identifier Type: -
Identifier Source: org_study_id
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NA
Exercise Intervention in Institutionalized Elderly People
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UNKNOWN
PHASE2
A Combined Aerobic and Resistance Training Program for Adults With Psychotic Disorders
NCT05719116
ACTIVE_NOT_RECRUITING
NA
Exercise, Brain, Cognition, OMICs, Molecular Markers and Functionality in People at Risk of Mild Cognitive Impairment
NCT03923712
COMPLETED
NA
Aerobic Group Exercise for Adolescents With Depression
NCT04695145
COMPLETED
NA
Physical Activity in Patients With Severe Mental Illness
NCT01329094
COMPLETED
Physical Health Improvement Intervention for People Admitted to Mental Health Service
NCT06996899
NOT_YET_RECRUITING
NA