The Effects of Different Modalities of Exercise in Patients With Schizophrenia
NCT ID: NCT04987151
Last Updated: 2021-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
105 participants
INTERVENTIONAL
2021-10-31
2022-07-31
Brief Summary
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Ethics and dissemination: This study was approved by the ethics committees for Biomedical Research at the CEU Cardenal Herrera University of Valencia in Spain (reference number: CEI18/215). Participants will be fully informed of the purpose and procedures of the study, and written informed consent will be obtained from every participant. The results from this study will be published in peer-reviewed journals and presented in scientific conferences.
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Detailed Description
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A multicentre, single-blinded (evaluator), randomised, wait-list controlled (ratio 2:2:2:1) trial will be conducted with 105 patients recruited from different psychosocial care centres. The participants will be randomised into three 16-week training groups comprising 48 sessions lasting one hour each, or to the wait-list control group. The training groups will complete aerobic, strength, or mixed (aerobic + strength) training. The participants will be assessed before, immediately after, and 6 months after the end of the intervention. All the patients in the wait-list control group (n = 15) will receive one of the three trainings immediately after the intervention. The study variables will include positive symptomatology, negative symptomatology, and general symptomology (using the Positive and Negative Syndrome Scale) as the primary outcome; as secondary outcome: body composition (by assessing body mass index, body fat mass and waist circumference), physical activity levels (International Physical Activity Questionnaire-Short Form), and quality of life (abbreviated World Health Organization Quality of Life questionnaire).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Strength training
Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength training exercise involving the major muscle groups.
Experimental-Strength training
Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength training exercise involving the major muscle groups
Aerobic training
Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to brisk walking,
Experimental-Aerobic training
Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to brisk walking.
Strength/Aerobic training
Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching), 15 minutes are allocated to brisk walking and 25 minutes are allocated to strength training involving the major muscle groups
Experimental-Strength/Aerobic training
Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching), 15 minutes are allocated to brisk walking and 25 minutes are allocated to strength training involving the major muscle groups.
Control Group
All the patients in the wait-list control group will receive one of the three trainings immediately after the intervention.
No interventions assigned to this group
Interventions
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Experimental-Strength training
Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength training exercise involving the major muscle groups
Experimental-Aerobic training
Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to brisk walking.
Experimental-Strength/Aerobic training
Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching), 15 minutes are allocated to brisk walking and 25 minutes are allocated to strength training involving the major muscle groups.
Eligibility Criteria
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Inclusion Criteria
* Age between 18-65 years
Exclusion Criteria
* Patients with mental disabilities
* Patients who present motor or behavioral pathologies that prevent the realization of the exercise training.
18 Years
65 Years
ALL
No
Sponsors
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Cardenal Herrera University
OTHER
Responsible Party
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Laura García Garcés
Head of Nursing and Physiotherapy
Locations
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Universidad CEU-Cardenal Herrera
Valencia, , Spain
Countries
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Central Contacts
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References
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Garcia-Garces L, Lacamara Cano S, Cebolla Melia Y, Sanchez-Lopez MI, Marques Azcona D, Lison JF, Peyro-Gregori L. Comparison of three different exercise training modalities (aerobic, strength and mixed) in patients with schizophrenia: study protocol for a multicentre randomised wait-list controlled trial. BMJ Open. 2021 Sep 17;11(9):e046216. doi: 10.1136/bmjopen-2020-046216.
Other Identifiers
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UNIVERSITY UCH-CEU
Identifier Type: -
Identifier Source: org_study_id
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