Exercise Intervention for People With Schizophrenia (CREW) (CREW)
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| ClinicalTrials.gov Identifier: NCT06044038 |
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Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia | Behavioral: Physical activity Behavioral: Cognitive rehabilitation program | Not Applicable |
Schizophrenia is a common public health issue that generates a social and economic burden. Individuals affected by schizophrenia experience severe and chronic levels of disability that derive from acute psychotic symptoms, as well as cognitive impairments for which available treatments offer only limited benefits. Moreover, their life expectancy is lower, and they have a higher prevalence of heart diseases risk factors such as obesity, dyslipidemia, smoking, hypertension, diabetes and physical inactivity than the general population. The World Health Organization and the European Mental Health Action Plan 2013-2020 acknowledge the role of physical activity in mental health and encourage the inclusion of lifestyle changes in education and treatment programs for people with mental illness, delivered in primary and secondary healthcare settings. The benefits of regular physical activity are well-recognized and are inversely associated with mortality risk and the incidence of many chronic diseases. Moreover, it plays a critical role in preserving and even improving cognitive function throughout the lifespan. However, people with schizophrenia tend to be less engaged in physical activity programs than the general population and report a range of barriers such as pain, side effects of medications and negative symptoms.
The purpose of this trial is to evaluate the efficacy of an exercise-based intervention program among people with schizophrenia.
All individuals with schizophrenia were screened for eligibility. After verifying inclusion and exclusion criteria and after eligibility is confirmed, written informed consent must be obtained prior to randomization. Baseline patient characteristics (i.e., demographics, medical history, laboratory test results) have been collected and recorded for further assessment. Randomization was performed during the inclusion visit (T1). Randomization will be performed centrally using an internet-based system. The identification number (ID) and the treatment allocation will be assigned by the randomization system. Patients were randomized to physical activity group or usual care by a 2:1 allocation. After the randomization, all participants underwent the same battery of tests and questionnaires according to the study protocol.
All patients were involved in the usual care cognitive program. It was held in weekly 90-minute sessions in a Psychiatric Rehabilitation Center of the Healthcare District of Ferrara. Specialized psychiatric therapists conduct this program with groups of 5-10 participants, based on a Cognitive Remediation model. Each session consists of welcoming participants, reviewing tasks conducted in the last meeting, and assignment of new pen-and-pencil cognitive and metacognitive tasks. Tasks include games and exercises (e.g., sudoku, crosswords), as well as discussions aimed at improving short- and long-term memory (i.e., repeating sequences of words and numbers), executive functions, and social cognition, with progressive adaptation of task difficulty. The total number of sessions is 50 for a duration of 12 months. In addition, the intervention arm was involved in a supervised exercise-based program. They could voluntarily participate in a variety of activities such as walking or Nordic walking groups, gentle gymnastics, soccer, swimming, and volleyball. Each activity was scheduled twice a week.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Prevention |
| Official Title: | Enhancing Functional Capacity and Body Composition of Individuals With Schizophrenia Through a Physical Exercise Intervention |
| Actual Study Start Date : | December 1, 2017 |
| Estimated Primary Completion Date : | December 31, 2025 |
| Estimated Study Completion Date : | December 31, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Physical activity group
Participation in supervised activities such as walking or Nordic walking groups, gentle gymnastics, soccer, swimming, and volleyball. Each activity was scheduled twice a week.
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Behavioral: Physical activity
Bi-weekly supervised physical activity intervention Behavioral: Cognitive rehabilitation program weekly 90-minute session consisting of welcoming participants, reviewing tasks conducted in the last meeting, and assignment of new pen-and-pencil cognitive and metacognitive tasks. |
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Usual care group
Participants in the control group attended weekly 90-minute cognitive rehabilitation sessions according to the usual care procedure in this type of population.
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Behavioral: Cognitive rehabilitation program
weekly 90-minute session consisting of welcoming participants, reviewing tasks conducted in the last meeting, and assignment of new pen-and-pencil cognitive and metacognitive tasks. |
- Peak Oxygen Uptake (VO2peak) [ Time Frame: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years) ]Measurement of cardiorespiratory fitness, reported as ml/kg/min and estimated through a moderate and perceptually regulated 1km treadmill walk test (1k-TWT) or through related short-forms (500m or 200m)
- Body Mass Index (kg/m²) [ Time Frame: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years) ]Derived from the measurement of weight in kilograms and height in meters
- Waist circumference (cm) [ Time Frame: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years) ]Measurement of waist circumference
- Screen for Cognitive Impairment in Psychiatry (SCIP) [ Time Frame: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years) ]Values range from 0 to >100, higher scores mean a better outcome
- Frontal Assessment Battery (FAB) [ Time Frame: First assessment at the date of enrolment (baseline) and subsequently every six months until the date of the end of follow-up (up to 2 years) ]Values range from 0 to18, higher scores mean a better outcome
- Adherence [ Time Frame: From date of enrollment until the date of the end of follow-up (up to 2 years) ]Number of physical activity sessions attended by the participants and the number of drop-outs
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients diagnosed with schizophrenia for at least 1 year
- On antipsychotic medications with the same therapeutic regimen for at least 3 months before enrolment
- Free of symptomatic peripheral arterial occlusive disease and cardiovascular, pulmonary, neurological, metabolic, and orthopaedic disorders that could interfere with physical activity sessions
Exclusion Criteria:
- Recent modification of the therapeutic regimen
- Presence of symptomatic peripheral arterial occlusive disease and cardiovascular, pulmonary, neurological, metabolic, and orthopaedic disorders that could interfere with physical activity sessions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06044038
| Contact: Simona Mandini, PhD | +39 0535455963 | simona.mandini@unife.it | |
| Contact: Gianni Mazzoni, Professor | +39 0535455963 | gianni.mazzoni@unife.it |
| Italy | |
| Center for Exercise Science and Sport | Recruiting |
| Ferrara, Italy, 44123 | |
| Contact: Simona Mandini, PhD +39 0535455963 simona.mandini@unife.it | |
| Contact: Andrea Raisi, MSc +39 0535455963 andrea.raisi@unife.it | |
| Principal Investigator: Simona Mandini, PhD | |
| Sub-Investigator: Andrea Raisi, MSc | |
| Sub-Investigator: Gianni Mazzoni, Professor | |
| Sub-Investigator: Tommaso Piva, MSc | |
| Sub-Investigator: Valentina Zerbini, MSc | |
| Sub-Investigator: Martino Belvederi Murri, Professor | |
| Sub-Investigator: Erica Menegatti, PhD | |
| Sub-Investigator: Giovanni Grazzi, Professor | |
| Study Director: | Gianni Mazzoni, Professor | Università degli Studi di Ferrara | |
| Principal Investigator: | Simona Mandini, PhD | Università degli Studi di Ferrara |
| Responsible Party: | Mandini Simona, Professor, Università degli Studi di Ferrara |
| ClinicalTrials.gov Identifier: | NCT06044038 |
| Other Study ID Numbers: |
CSB-23-02 |
| First Posted: | September 21, 2023 Key Record Dates |
| Last Update Posted: | September 21, 2023 |
| Last Verified: | September 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Schizophrenia Physical activity Mental disorder |
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Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |