Moderate-to-Vigorous Intensity Physical Activity and Severe Mental Illness

NCT06338917 | Active Not Recruiting

• 1 other identifier: File 2022 DI 61
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Mental Health Issue

Keywords

mental illness; exercise; sedentary behaviour; lifestyle

Outcome Measures

Primary Outcomes (4)

• 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, 4, 7 and 10 follow-up months.

• 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, 4 and 7 months.

• 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, 4 and 7 months.

• 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, 4 and 7 months.

Secondary Outcomes (8)

• 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.

Other Outcomes (2)

• Patient Reported Experience Measures (PREM) and Patient Reported Outcome Measures (PROM)

  Measurement will be at the final of the intervention, month 7.

• Mood

  Measurement will be at the beginning and during all the physical activity sessions.

Study Arms (2)

Intervention group

EXPERIMENTAL

Participation in a moderate-to-vigorous intensity physical activity program a part from the usual health care treatment

Behavioral: Moderate-to-vigorous intensity physical activity program (+moviMENT)

Control group

NO INTERVENTION

Following the usual health care treatment

Interventions

Moderate-to-vigorous intensity physical activity program (+moviMENT) 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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead
• IRIS-CC: collaborator
• AGAUR: collaborator

Study Sites (1)

University of Vic

Vic, Barcelona, 08500, Spain

Location

Related Publications (54)

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  PMID: 41381109 DERIVED

MeSH Terms

Conditions

Mental Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MsC in physical activity and health and graduate in physical activity and sport science

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 1, 2024
• Study Start: June 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available following the publication of the results from the study protocol. No end date.
• Access Criteria: Everyone who will be interested in the results of the pragmatic clinical trial will be able to access the IPD. The information shared will be the analysis data set, tables and figures. Readers will be able to access the IPD through supplementary material.

Locations

ES (1)