Moderate-to-Vigorous Intensity Physical Activity and Severe Mental Illness (+MoviMENT)

September 23, 2025 updated by: Mariona Caro Crous, University of Vic - Central University of Catalonia

Moderate-to-Vigorous Intensity Physical Activity as a Tool for Severe Mental Illness Recuperation Process: Study Protocol for a Pragmatic Controlled Clinical Trial (+moviMENT)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Vic, Barcelona, Spain, 08500
        • University of Vic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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)
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.
No Intervention: Control group
Following the usual health care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: 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.
Measurement will be at the beginning, 4, 7 and 10 follow-up months.
Cognitive functioning
Time Frame: Measurement will be at the beginning, 4 and 7 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.
Measurement will be at the beginning, 4 and 7 months.
Psychotic symptomatology
Time Frame: Measurement will be at the beginning, 4 and 7 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.
Measurement will be at the beginning, 4 and 7 months.
Depression symptomatology
Time Frame: Measurement will be at the beginning, 4 and 7 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.
Measurement will be at the beginning, 4 and 7 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-measured physical activity and sedentary behaviour pattern
Time Frame: Measurement will be at the beginning, 4 and 7 months.
To measure 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 and 7 months.
Fitness self-perception
Time Frame: Measurement will be at the beginning, 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.
Measurement will be at the beginning, 4, 7 and 10 follow-up months.
Quality of life self-perception
Time Frame: Measurement will be at the beginning, 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.
Measurement will be at the beginning, 4, 7 and 10 follow-up months.
Physical activity pattern self-perception
Time Frame: Measurement will be at the beginning, 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.
Measurement will be at the beginning, 4, 7 and 10 follow-up months.
Sedentary behaviour pattern self-perception
Time Frame: Measurement will be at the beginning, 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.
Measurement will be at the beginning, 4, 7 and 10 follow-up months.
Cardiorespiratory endurance
Time Frame: Measurement will be at the beginning, 4 and 7 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.
Measurement will be at the beginning, 4 and 7 months.
Agility
Time Frame: Measurement will be at the beginning, 4 and 7 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.
Measurement will be at the beginning, 4 and 7 months.
Lower limb strength
Time Frame: Measurement will be at the beginning, 4 and 7 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.
Measurement will be at the beginning, 4 and 7 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood
Time Frame: 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".
Measurement will be at the beginning and during all the physical activity sessions.
Patient Reported Experience Measures (PREM) and Patient Reported Outcome Measures (PROM)
Time Frame: Measurement will be at the final of the intervention, month 7.
PREMs (Patient Reported Experience Measures) refer to measures that assess the patient's experience of the care received. These measures are obtained directly from patients through surveys or questionnaires and are used to assess aspects such as communication with health care providers, participation in decision-making, access to health care services, overall satisfaction and other aspects of the patient experience. PROMs (Patient Reported Outcome Measures) focus on the measurement of self-reported outcomes related to their health, symptoms and quality of life. These measures are also obtained directly from patients through surveys or questionnaires and assess aspects such as pain intensity, physical functioning, emotional well-being, sleep quality and other health domains that are relevant to the patient. PROMs provide insight into the patient's perspective on the impact of a disease, treatment or intervention on their daily life and general well-being.
Measurement will be at the final of the intervention, month 7.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vic - Central University of Catalonia

Collaborators

IRIS-CC
AGAUR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • File 2022 DI 61

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and supplementary material) will be shared. Only IPD used in the results will be shared.

IPD Sharing Time Frame

Data will be available following the publication of the results from the study protocol. No end date.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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