Exercise Intervention for People With Schizophrenia (CREW)

NCT ID: NCT06044038

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2025-12-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

Bi-weekly supervised physical activity intervention

Cognitive rehabilitation program

Intervention Type: BEHAVIORAL

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.

Group Type: OTHER

Cognitive rehabilitation program

Intervention Type: BEHAVIORAL

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.

Interventions

Physical activity

Bi-weekly supervised physical activity intervention

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Mandini Simona

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gianni Mazzoni, Professor

Role: STUDY_DIRECTOR

Università degli Studi di Ferrara

Simona Mandini, PhD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Ferrara

Locations

Center for Exercise Science and Sport

Ferrara, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Simona Mandini, PhD

Role: CONTACT

simona.mandini@unife.it

+39 0535455963

Gianni Mazzoni, Professor

Role: CONTACT

gianni.mazzoni@unife.it

+39 0535455963

Facility Contacts

Simona Mandini, PhD

Role: primary

simona.mandini@unife.it

+39 0535455963

Andrea Raisi, MSc

Role: backup

andrea.raisi@unife.it

+39 0535455963

References

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.

Reference Type: RESULT

PMID: 35337370 (View on PubMed)

Other Identifiers

CSB-23-02

Identifier Type: -

Identifier Source: org_study_id