Exercise Intervention for People With Schizophrenia (CREW)

Schizophrenia Clinical Trial

— CREW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06044038
• Other study ID #: CSB-23-02
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Università degli Studi di Ferrara
• Contact: Simona Mandini, PhD
• Phone: +39 0535455963
• Email: simona.mandini[@]unife.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Physical activity
Bi-weekly supervised physical activity intervention
• 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.

Locations

Country	Name	City	State
Italy	Center for Exercise Science and Sport	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 pan — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Oxygen Uptake (VO2peak)	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)
Primary	Body Mass Index (kg/m²)	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)
Primary	Waist circumference (cm)	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)
Primary	Screen for Cognitive Impairment in Psychiatry (SCIP)	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)
Primary	Frontal Assessment Battery (FAB)	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	Adherence	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)