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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Schizoaffective Disorder
• Intervention / Treatment: Other: 8-week indoor physical activity program; Other: 8-week outdoor physical activity program

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Medhi HOUSNI, Md; Phone Number: +33 (0)477127885; Email: Mehdi.Housni@chu-st-etienne.fr

Study Locations

• France
  • France
    • Saint-Etienne, France, France, 42055
      • Recruiting
      • CHU de Saint-Etienne
      • Contact: Medhi HOUSNI, Md; Phone Number: +33 (0)477127885; Email: Medhi.Housni@chu-st-etienne.fr
      • Principal Investigator: Medhi HOUSNI, Md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INT group; 8-week indoor physical activity program (in a gymnasium)	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.
Experimental: EXT group; 8-week outdoor physical activity program	Other: 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.
No Intervention: TEM group; Without physical activiy program (no change in routine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical global Impression (CGI) scale	The patient's overall symptomatology and functioning will be assessed by the Clinical global Impression (CGI) scale. The CGI scale is assessed on a 7-point scale, with the severity of illness rated from 1 (normal) to 7 (very seriously ill). CGI scores range from 1 (much improved) to 7 (much worse).	Weeks 2, 10 and 22
Personal and social performance (PSP) scale	The patient's overall symptomatology and functioning will be assessed by the Personal and social performance (PSP) scale. Higher scores indicate higher levels of perceived stress.	Weeks 2, 10 and 22
Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)	Cognitive disorders reported will be assessed using the French version of the Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS). The total score (range 0-84) is calculated as the sum of all items, with higher scores reflecting a greater Self-Appraisals of Cognitive Deficits.	Weeks 2, 10 and 22.
VO2 max	VO2 max will be estimated on the basis of heart rate measured during a submaximal test on an ergonomic bicycle.	Weeks 2, 10 and 22.
Maximum force	The maximum force produced by the knee extensors will be measured on a dynamometer.	Weeks 2, 10 and 22.
Flexibility	Flexibility of the posterior chain will be measured with the sit and reach test.	Weeks 2, 10 and 22.
Spatio-temporal coordination	Spatio-temporal coordination will be assessed by measuring individual reaction times.	Weeks 2, 10 and 22.
Balance	Balance will be tested by stabilometry on a Winposturo force platform.	Weeks 2, 10 and 22.
IPAQ questionnaire	The level of sedentariness will be measured by the IPAQ questionnaire. This questionnaire classifies the subject according to 3 levels of activity: inactive, moderate, high.	Weeks 2, 10 and 22.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Jean Monnet University
• Investigators: Principal Investigator: Medhi HOUSNI, Md, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 30, 2025
• First Submitted That Met QC Criteria: July 7, 2025
• First Posted (Actual): July 10, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Physical fitness; Mental health; Schizophrenia disorders
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior; Personal Satisfaction; Schizophrenia; Psychotic Disorders; Psychological Well-Being
• Other Study ID Numbers: 25CH062; 2025-A00700-49 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No