Exercise Intervention for People With Schizophrenia (CREW)

NCT06044038 | Unknown DMC

• 1 other identifier: CSB-23-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Physical activity; Mental disorder

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (1)

• Adherence

  From date of enrollment until the date of the end of follow-up (up to 2 years)

Study Arms (2)

Physical activity group

EXPERIMENTAL

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; Behavioral: Cognitive rehabilitation program

Usual care group

OTHER

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

Interventions

Physical activity BEHAVIORAL

Bi-weekly supervised physical activity intervention

Physical activity group

Cognitive rehabilitation program 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.

Physical activity group; Usual care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Center for Exercise Science and Sport

Ferrara, 44123, Italy

RECRUITING

Related 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 pandemic. BMC Sports Sci Med Rehabil. 2022 Mar 25;14(1):48. doi: 10.1186/s13102-022-00440-2.

  PMID: 35337370 RESULT

MeSH Terms

Conditions

Schizophrenia; Motor Activity; Mental Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gianni Mazzoni, Professor

  Università degli Studi di Ferrara

  STUDY DIRECTOR

• Simona Mandini, PhD

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Mandini, PhD

CONTACT

+39 0535455963; simona.mandini@unife.it

Gianni Mazzoni, Professor

CONTACT

+39 0535455963; gianni.mazzoni@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 21, 2023
• Study Start: December 1, 2017
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

IT (1)