The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE September 5, 2023
First Posted Date  ICMJE September 21, 2023
Last Update Posted Date September 21, 2023
Actual Study Start Date  ICMJE December 1, 2017
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2023)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2023)
  • 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 composition [ 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) ]
    BMI (kg/m²), derived from the measurement of weight in kilograms and height in meters
  • Body composition [ 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) ]
    Waist circumference (cm)
  • Cognitive function [ 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) ]
    Screen for Cognitive Impairment in Psychiatry (SCIP). Values range from 0 to >100, higher scores mean a better outcome
  • Cognitive function [ 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) ]
    Frontal Assessment Battery (FAB). Values range from 0 to18, higher scores mean a better outcome
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2023)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Intervention for People With Schizophrenia (CREW)
Official Title  ICMJE Enhancing Functional Capacity and Body Composition of Individuals With Schizophrenia Through a Physical Exercise Intervention
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Physical activity
    • Behavioral: Cognitive rehabilitation program
  • 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.
    Intervention: Behavioral: Cognitive rehabilitation program
Publications * Mandini S, Morelli M, Belvederi Murri M, Grassi L, Masotti S, Simani L, Zerbini V, Raisi A, Piva T, Grazzi G, Mazzoni G. Adherence to a guided walking program with amelioration of cognitive functions in subjects with schizophrenia even during COVID-19 pandemic. BMC Sports Sci Med Rehabil. 2022 Mar 25;14(1):48. doi: 10.1186/s13102-022-00440-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2023)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Simona Mandini, PhD +39 0535455963 simona.mandini@unife.it
Contact: Gianni Mazzoni, Professor +39 0535455963 gianni.mazzoni@unife.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06044038
Other Study ID Numbers  ICMJE CSB-23-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mandini Simona, Università degli Studi di Ferrara
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Università degli Studi di Ferrara
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gianni Mazzoni, Professor Università degli Studi di Ferrara
Principal Investigator: Simona Mandini, PhD Università degli Studi di Ferrara
PRS Account Università degli Studi di Ferrara
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP