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

September 19, 2023 updated by: Mandini Simona, Università degli Studi di Ferrara

Enhancing Functional Capacity and Body Composition of Individuals With Schizophrenia Through a Physical Exercise Intervention

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Ferrara, Italy, 44123
        • Recruiting
        • Center for Exercise Science and Sport
        • Contact:
        • Sub-Investigator:
          • Gianni Mazzoni, Professor
        • Sub-Investigator:
          • Andrea Raisi, MSc
        • Sub-Investigator:
          • Tommaso Piva, MSc
        • Sub-Investigator:
          • Valentina Zerbini, MSc
        • Contact:
        • Principal Investigator:
          • Simona Mandini, PhD
        • Sub-Investigator:
          • Martino Belvederi Murri, Professor
        • Sub-Investigator:
          • Erica Menegatti, PhD
        • Sub-Investigator:
          • Giovanni Grazzi, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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
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)
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
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)
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
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)
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
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of enrollment until the date of the end of follow-up (up to 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Investigators

  • Study Director: Gianni Mazzoni, Professor, Università degli Studi di Ferrara
  • Principal Investigator: Simona Mandini, PhD, Università degli Studi di Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSB-23-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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