Mental Health Issue+MoviMENTNCT06338917
Moderate-to-Vigorous Intensity Physical Activity and Severe Mental Illness
A study testing Moderate-to-vigorous intensity physical activity program (+moviMENT) in people with Mental Health Issue, run by University of Vic - Central University of Catalonia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Moderate-to-vigorous intensity physical activity program (+moviMENT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- Moderate-to-vigorous intensity physical activity program (+moviMENT)
- Keywords
- mental illness, exercise, sedentary behaviour, lifestyle
- Medical subject headings
- Mental Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-to-vigorous intensity physical activity program (+moviMENT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participation in a moderate-to-vigorous intensity physical activity program a part from the usual health care treatment Receives: Behavioral: Moderate-to-vigorous intensity physical activity program (+moviMENT) |
| Control group | No intervention | Following the usual health care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measurement will be at the beginning, 4 and 7 months.
Secondary outcomes (8)
Device-measured physical activity and sedentary behaviour pattern
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).
Measured: Measurement will be at the beginning, 4 and 7 months.
Fitness self-perception
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.
Measured: Measurement will be at the beginning, 4, 7 and 10 follow-up months.
Quality of life self-perception
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.
Measured: Measurement will be at the beginning, 4, 7 and 10 follow-up months.
Physical activity pattern self-perception
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.
Measured: Measurement will be at the beginning, 4, 7 and 10 follow-up months.
Sedentary behaviour pattern self-perception
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.
Measured: Measurement will be at the beginning, 4, 7 and 10 follow-up months.
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.
Measured: Measurement will be at the beginning, 4 and 7 months.
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.
Measured: Measurement will be at the beginning, 4 and 7 months.
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.
Measured: Measurement will be at the beginning, 4 and 7 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Jun 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Collaborators
- IRIS-CC, AGAUR
- Responsible party
- Principal investigator, Mariona Caro Crous, University of Vic - Central University of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338917
- Sponsor's protocol ID
- File 2022 DI 61
- Acronym
- +MoviMENT
- Status last verified
- Sep 2025
- First submitted
- 13 Mar 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Chen MD, I JH, Pellegrini CA, Chen HF, Su CY, Chang YC. The facilitators and barriers to physical activity scale for people with mental illness in Taiwan: development and validation. Disabil Rehabil. 2022 Aug;44(17):4879-4887. doi: 10.1080/09638288.2021.1916627. Epub 2021 Apr 25.
PubMed 33896304Glover CM, Ferron JC, Whitley R. Barriers to exercise among people with severe mental illnesses. Psychiatr Rehabil J. 2013 Mar;36(1):45-7. doi: 10.1037/h0094747.
PubMed 23477650Thogersen-Ntoumani C, Kritz M, Grunseit A, Chau J, Ahmadi M, Holtermann A, Koster A, Tudor-Locke C, Johnson N, Sherrington C, Paudel S, Maher C, Stamatakis E. Barriers and enablers of vigorous intermittent lifestyle physical activity (VILPA) in physically inactive adults: a focus group study. Int J Behav Nutr Phys Act. 2023 Jul 4;20(1):78. doi: 10.1186/s12966-023-01480-8.
PubMed 37403160Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
PubMed 33239350Schuch FB, Vancampfort D, Firth J, Rosenbaum S, Ward PB, Silva ES, Hallgren M, Ponce De Leon A, Dunn AL, Deslandes AC, Fleck MP, Carvalho AF, Stubbs B. Physical Activity and Incident Depression: A Meta-Analysis of Prospective Cohort Studies. Am J Psychiatry. 2018 Jul 1;175(7):631-648. doi: 10.1176/appi.ajp.2018.17111194. Epub 2018 Apr 25.
PubMed 29690792Malchow B, Reich-Erkelenz D, Oertel-Knochel V, Keller K, Hasan A, Schmitt A, Scheewe TW, Cahn W, Kahn RS, Falkai P. The effects of physical exercise in schizophrenia and affective disorders. Eur Arch Psychiatry Clin Neurosci. 2013 Sep;263(6):451-67. doi: 10.1007/s00406-013-0423-2. Epub 2013 Jul 20.
PubMed 23873090DE Hert M, Correll CU, Bobes J, Cetkovich-Bakmas M, Cohen D, Asai I, Detraux J, Gautam S, Moller HJ, Ndetei DM, Newcomer JW, Uwakwe R, Leucht S. Physical illness in patients with severe mental disorders. I. Prevalence, impact of medications and disparities in health care. World Psychiatry. 2011 Feb;10(1):52-77. doi: 10.1002/j.2051-5545.2011.tb00014.x.
PubMed 21379357Scheewe TW, Backx FJ, Takken T, Jorg F, van Strater AC, Kroes AG, Kahn RS, Cahn W. Exercise therapy improves mental and physical health in schizophrenia: a randomised controlled trial. Acta Psychiatr Scand. 2013 Jun;127(6):464-73. doi: 10.1111/acps.12029. Epub 2012 Oct 26.
PubMed 23106093Scheewe TW, Takken T, Kahn RS, Cahn W, Backx FJ. Effects of exercise therapy on cardiorespiratory fitness in patients with schizophrenia. Med Sci Sports Exerc. 2012 Oct;44(10):1834-42. doi: 10.1249/MSS.0b013e318258e120.
PubMed 22525773Heissel A, Heinen D, Brokmeier LL, Skarabis N, Kangas M, Vancampfort D, Stubbs B, Firth J, Ward PB, Rosenbaum S, Hallgren M, Schuch F. Exercise as medicine for depressive symptoms? A systematic review and meta-analysis with meta-regression. Br J Sports Med. 2023 Aug;57(16):1049-1057. doi: 10.1136/bjsports-2022-106282. Epub 2023 Feb 1.
PubMed 36731907Garcia-Garces L, Sanchez-Lopez MI, Cano SL, Melia YC, Marques-Azcona D, Bivia-Roig G, Lison JF, Peyro-Gregori L. The short and long-term effects of aerobic, strength, or mixed exercise programs on schizophrenia symptomatology. Sci Rep. 2021 Dec 21;11(1):24300. doi: 10.1038/s41598-021-03761-3.
PubMed 34934115Acil AA, Dogan S, Dogan O. The effects of physical exercises to mental state and quality of life in patients with schizophrenia. J Psychiatr Ment Health Nurs. 2008 Dec;15(10):808-15. doi: 10.1111/j.1365-2850.2008.01317.x.
PubMed 19012672Zschucke E, Gaudlitz K, Strohle A. Exercise and physical activity in mental disorders: clinical and experimental evidence. J Prev Med Public Health. 2013 Jan;46 Suppl 1(Suppl 1):S12-21. doi: 10.3961/jpmph.2013.46.S.S12. Epub 2013 Jan 30.
PubMed 23412549Gray R, Hardy S, Anderson KH. Physical health and severe mental illness: if we don't do something about it, who will? Int J Ment Health Nurs. 2009 Oct;18(5):299-300. doi: 10.1111/j.1447-0349.2009.00640.x. No abstract available.
PubMed 19740138Dimeo F, Bauer M, Varahram I, Proest G, Halter U. Benefits from aerobic exercise in patients with major depression: a pilot study. Br J Sports Med. 2001 Apr;35(2):114-7. doi: 10.1136/bjsm.35.2.114.
PubMed 11273973
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate-to-Vigorous Intensity Physical Activity as a Tool for Severe Mental Illness Recuperation Process: Study Protocol for a Pragmatic Controlled Clinical Trial (+moviMENT)
- ClinicalTrials.gov ID
- NCT06338917
- Acronym / sponsor ID
- +MoviMENT / File 2022 DI 61
- Conditions
- Mental Health Issue
- Keywords
- mental illness, exercise, sedentary behaviour, lifestyle
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Collaborators
- IRIS-CC, AGAUR
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Moderate-to-vigorous intensity physical activity program (+moviMENT)Participation in a moderate-to-vigorous intensity physical activity program a part from the usual health care treatment |
| Control group | No intervention | –Following the usual health care treatment |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention group |
Primary outcome
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.
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.
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.
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.
8 secondary outcomes
Device-measured physical activity and sedentary behaviour pattern
Time frame: 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.
Quality of life self-perception
Time frame: 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.
Sedentary behaviour pattern self-perception
Time frame: 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.
Agility
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Background: PubMed 33896304Chen MD, I JH, Pellegrini CA, Chen HF, Su CY, Chang YC. The facilitators and barriers to physical activity scale for people with mental illness in Taiwan: development and validation. Disabil Rehabil. 2022 Aug;44(17):4879-4887. doi: 10.1080/09638288.2021.1916627. Epub 2021 Apr 25.
- Background: PubMed 23477650Glover CM, Ferron JC, Whitley R. Barriers to exercise among people with severe mental illnesses. Psychiatr Rehabil J. 2013 Mar;36(1):45-7. doi: 10.1037/h0094747.
- Background: PubMed 37403160Thogersen-Ntoumani C, Kritz M, Grunseit A, Chau J, Ahmadi M, Holtermann A, Koster A, Tudor-Locke C, Johnson N, Sherrington C, Paudel S, Maher C, Stamatakis E. Barriers and enablers of vigorous intermittent lifestyle physical activity (VILPA) in physically inactive adults: a focus group study. Int J Behav Nutr Phys Act. 2023 Jul 4;20(1):78. doi: 10.1186/s12966-023-01480-8.
- Background: PubMed 33239350Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
- Background: PubMed 29690792Schuch FB, Vancampfort D, Firth J, Rosenbaum S, Ward PB, Silva ES, Hallgren M, Ponce De Leon A, Dunn AL, Deslandes AC, Fleck MP, Carvalho AF, Stubbs B. Physical Activity and Incident Depression: A Meta-Analysis of Prospective Cohort Studies. Am J Psychiatry. 2018 Jul 1;175(7):631-648. doi: 10.1176/appi.ajp.2018.17111194. Epub 2018 Apr 25.
- Background: PubMed 23873090Malchow B, Reich-Erkelenz D, Oertel-Knochel V, Keller K, Hasan A, Schmitt A, Scheewe TW, Cahn W, Kahn RS, Falkai P. The effects of physical exercise in schizophrenia and affective disorders. Eur Arch Psychiatry Clin Neurosci. 2013 Sep;263(6):451-67. doi: 10.1007/s00406-013-0423-2. Epub 2013 Jul 20.
- Background: PubMed 21379357DE Hert M, Correll CU, Bobes J, Cetkovich-Bakmas M, Cohen D, Asai I, Detraux J, Gautam S, Moller HJ, Ndetei DM, Newcomer JW, Uwakwe R, Leucht S. Physical illness in patients with severe mental disorders. I. Prevalence, impact of medications and disparities in health care. World Psychiatry. 2011 Feb;10(1):52-77. doi: 10.1002/j.2051-5545.2011.tb00014.x.
- Background: PubMed 23106093Scheewe TW, Backx FJ, Takken T, Jorg F, van Strater AC, Kroes AG, Kahn RS, Cahn W. Exercise therapy improves mental and physical health in schizophrenia: a randomised controlled trial. Acta Psychiatr Scand. 2013 Jun;127(6):464-73. doi: 10.1111/acps.12029. Epub 2012 Oct 26.
- Background: PubMed 22525773Scheewe TW, Takken T, Kahn RS, Cahn W, Backx FJ. Effects of exercise therapy on cardiorespiratory fitness in patients with schizophrenia. Med Sci Sports Exerc. 2012 Oct;44(10):1834-42. doi: 10.1249/MSS.0b013e318258e120.
- Background: PubMed 36731907Heissel A, Heinen D, Brokmeier LL, Skarabis N, Kangas M, Vancampfort D, Stubbs B, Firth J, Ward PB, Rosenbaum S, Hallgren M, Schuch F. Exercise as medicine for depressive symptoms? A systematic review and meta-analysis with meta-regression. Br J Sports Med. 2023 Aug;57(16):1049-1057. doi: 10.1136/bjsports-2022-106282. Epub 2023 Feb 1.
- Background: PubMed 34934115Garcia-Garces L, Sanchez-Lopez MI, Cano SL, Melia YC, Marques-Azcona D, Bivia-Roig G, Lison JF, Peyro-Gregori L. The short and long-term effects of aerobic, strength, or mixed exercise programs on schizophrenia symptomatology. Sci Rep. 2021 Dec 21;11(1):24300. doi: 10.1038/s41598-021-03761-3.
- Background: PubMed 19012672Acil AA, Dogan S, Dogan O. The effects of physical exercises to mental state and quality of life in patients with schizophrenia. J Psychiatr Ment Health Nurs. 2008 Dec;15(10):808-15. doi: 10.1111/j.1365-2850.2008.01317.x.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-to-vigorous intensity physical activity program (+moviMENT) in people with Mental Health Issue, run by University of Vic - Central University of Catalonia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (time frame: Measurement will be at the beginning, 4, 7 and 10 follow-up months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06338917, which also lists 54 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.