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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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)
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.

Spain1 site
  • University of Vic

    Vic, Barcelona, 08500

Other trials in Spain

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.

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 groups in NCT06338917
Study groupRoleWhat they receive
Intervention groupExperimentalParticipation 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 groupNo interventionFollowing the usual health care treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  2. 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.

  3. 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.

  4. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  1. First posted1 Apr 2024
  2. Study start1 Jun 2024
  3. Primary completion31 Jan 2025
  4. Study completion31 Jan 2026 (estimated)

Resources

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)
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 33896304
  • Glover 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 23477650
  • Thogersen-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 37403160
  • Bull 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 33239350
  • Schuch 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 29690792
  • Malchow 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 23873090
  • DE 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 21379357
  • Scheewe 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 23106093
  • Scheewe 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 22525773
  • Heissel 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 36731907
  • Garcia-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 34934115
  • Acil 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 19012672
  • Zschucke 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 23412549
  • Gray 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 19740138
  • Dimeo 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

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.

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