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| Name | Class |
|---|---|
| IRIS-CC | UNKNOWN |
| AGAUR | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Experience Measures (PREM) and Patient Reported Outcome Measures (PROM) | 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. |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vic | Vic | Barcelona | 08500 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33896304 | Background | 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. | |
| 23477650 | Background | 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. |
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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.
Data will be available following the publication of the results from the study protocol. No end date.
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.
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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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.
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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.
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Measurement will be at the beginning, 4 and 7 months. |
| Measurement will be at the final of the intervention, month 7. |
| Mood | 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. |
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| 36482104 | Background | Stamatakis E, Ahmadi MN, Gill JMR, Thogersen-Ntoumani C, Gibala MJ, Doherty A, Hamer M. Association of wearable device-measured vigorous intermittent lifestyle physical activity with mortality. Nat Med. 2022 Dec;28(12):2521-2529. doi: 10.1038/s41591-022-02100-x. Epub 2022 Dec 8. |
| 41381109 | Derived | Caro-Crous M, Santos JM, Jabardo-Camprubi G, Brown WJ, Puig-Ribera A. Intermittent-vigorous intensity physical activity as a strategy for recovery in severe mental illness: study protocol for a pragmatic clinical trial. BMJ Open. 2025 Dec 11;15(12):e107357. doi: 10.1136/bmjopen-2025-107357. |