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Exercise Intervention for People With Schizophrenia (CREW) (CREW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06044038
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Mandini Simona, Università degli Studi di Ferrara

Brief Summary:
The study aims to investigate the feasibility and adherence of long-term, moderate-intensity different types of physical activity programs for individuals with schizophrenia. Secondary outcomes are related to the control of non-communicable disease risk factors and the improvement of exercise capacity, body composition and cognitive function.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Physical activity Behavioral: Cognitive rehabilitation program Not Applicable

Detailed Description:

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.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Simona Mandini, PhD +39 0535455963 simona.mandini@unife.it
Contact: Gianni Mazzoni, Professor +39 0535455963 gianni.mazzoni@unife.it

Locations
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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         
Sponsors and Collaborators
Università degli Studi di Ferrara
Investigators
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Study Director: Gianni Mazzoni, Professor Università degli Studi di Ferrara
Principal Investigator: Simona Mandini, PhD Università degli Studi di Ferrara
Publications of Results:
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mandini Simona, Università degli Studi di Ferrara:
Schizophrenia
Physical activity
Mental disorder
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders