Synergy Between Physical Activity and Outdoor Green Environments to Reduce the Intensity of Negative Symptoms in Schizophrenia.

NCT07058389 | Recruiting

• 2 other identifiers: 25CH0622025-A00700-49
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Physical activity appears to be a novel and original adjunctive therapeutic approach in the management of patients with schizophrenia. It may help reduce schizophrenic symptoms, act as a pro-cognitive therapy, improve quality of life, and reduce cardiovascular comorbidities. Moreover, some evidence suggests that physical activity practiced in a natural environment has even more positive effects on mental health compared to physical activity carried out indoors or in urban settings. Indeed, greater exposure to greenery is associated with a better perception of general health and with reduced levels of cortisol, anxiety, and depression. No study has yet attempted to examine the impact of physical activity in green (outdoor) spaces compared to indoor physical activity on the negative symptoms of patients suffering from schizophrenia. The aim of this study is therefore to test this hypothesis.

Conditions

Schizoaffective Disorder

Keywords

Schizophrenia disorders; Mental health; Quality of life; Physical fitness

Outcome Measures

Primary Outcomes (1)

• Self-evaluation of negative symptoms (SNS) questionnaire

  The primary outcome will be the evolution of negative symtoms, assessed using the Self-evaluation of negative symptoms (SNS) questionnaire. The total SNS score ranges from 0 to 40, where higher scores indicate greater severity of negative symptoms.

  Weeks 2, 10 and 22

Secondary Outcomes (9)

• Clinical global Impression (CGI) scale

  Weeks 2, 10 and 22

• Personal and social performance (PSP) scale

  Weeks 2, 10 and 22

• Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)

  Weeks 2, 10 and 22.

• VO2 max

  Weeks 2, 10 and 22.

• Maximum force

  Weeks 2, 10 and 22.

Study Arms (3)

INT group

EXPERIMENTAL

8-week indoor physical activity program (in a gymnasium)

Other: 8-week indoor physical activity program

EXT group

EXPERIMENTAL

8-week outdoor physical activity program

Other: 8-week outdoor physical activity program

TEM group

NO INTERVENTION

Without physical activiy program (no change in routine)

Interventions

8-week outdoor physical activity program OTHER

EXT group will perform aerobic and resistance exercises with a coach in adapted physical activities on a green environment in a parc. Sessions will be typically composed as follows: * Warm-up (20 min) * Aerobic exercise (30 min) at RPE 4 to 7 on the Borg scale * Muscular strengthening (25 min) at RPE 4 to 7 on the Borg scale * Cool-down, stretching and balance (15 min) EXR group will train for 8 weeks, twice a week for 1h30, following WHO recommendation.

EXT group

8-week indoor physical activity program OTHER

INT group will perform aerobic and resistance exercises with a coach in adapted physical activities, inside a conventional gym. Sessions will be typically composed as follows: * Warm-up (20 min) * Aerobic exercise (30 min) at RPE 4 to 7 on the Borg scale * Muscular strengthening (25 min) at RPE 4 to 7 on the Borg scale * Cool-down, stretching and balance (15 min) INT group will train for 8 weeks, twice a week for 1h30, following WHO recommendation.

INT group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with schizophrenia, aged 18 to 55 years
• Having persistent negative symptoms (SNS), negative symptoms self-assessment scale \> 7
• Regularly monitored in the psychiatry department.
• Have no medical contraindications to physical activity
• Subject affiliated with or entitled to a social security system.
• Subject having received informed information about the study and having co-signed, with the investigator, consent to participate in the study.
• Male or female.

You may not qualify if:

• Patient unsuitable for study in the opinion of the investigator
• Any subject with chronic joint pathologies (example: repeated sprains, patellar or ligament problems) or cardiac pathologies.
• Any subject presenting chronic or central neurological pathologies.
• Any subject deprived of liberty or subject to legal protection
• Excessive consumption of alcohol (\> 14 glasses per week) or caffeinated drinks (\> 400 mg of coffee per day).
• Pregnant women.
• Subject unable to understand the purpose and conditions of the study, unable to give consent.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Jean Monnet University: collaborator

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, France, 42055, France

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Psychological Well-Being

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Medhi HOUSNI, Md

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medhi HOUSNI, Md

CONTACT

(0)477127885; Mehdi.Housni@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)