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

NCT ID: NCT07058389

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-07
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

INT group

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

Group Type: EXPERIMENTAL

8-week indoor physical activity program

Intervention Type: 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.

EXT group

8-week outdoor physical activity program

Group Type: EXPERIMENTAL

8-week outdoor physical activity program

Intervention Type: 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.

TEM group

Without physical activiy program (no change in routine)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

8-week outdoor physical activity program

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.

Intervention Type: OTHER

8-week indoor physical activity program

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jean Monnet University

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medhi HOUSNI, Md

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Saint-Etienne

Saint-Etienne, France, France

Site Status: RECRUITING

Countries

France

Central Contacts

Medhi HOUSNI, Md

Role: CONTACT

Mehdi.Housni@chu-st-etienne.fr

(0)477127885 ext. +33

Facility Contacts

Medhi HOUSNI, Md

Role: primary

Medhi.Housni@chu-st-etienne.fr

(0)477127885 ext. +33

Other Identifiers

2025-A00700-49

Identifier Type: OTHER

Identifier Source: secondary_id

25CH062

Identifier Type: -

Identifier Source: org_study_id