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Recruiting NCT07058389

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

No phase Interventional Schizoaffective Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 8-week outdoor physical activity program, 8-week indoor physical activity program.
Who it may be relevant to
Registry conditions: Schizoaffective Disorder. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Self-evaluation of negative symptoms (SNS) questionnaire [Time frame: Weeks 2, 10 and 22]
Secondary outcome measures (9)
  • Clinical global Impression (CGI) scale [Time frame: Weeks 2, 10 and 22]
  • Personal and social performance (PSP) scale [Time frame: Weeks 2, 10 and 22]
  • Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS) [Time frame: Weeks 2, 10 and 22.]
  • VO2 max [Time frame: Weeks 2, 10 and 22.]
  • Maximum force [Time frame: Weeks 2, 10 and 22.]
  • Flexibility [Time frame: Weeks 2, 10 and 22.]
  • Spatio-temporal coordination [Time frame: Weeks 2, 10 and 22.]
  • Balance [Time frame: Weeks 2, 10 and 22.]
  • IPAQ questionnaire [Time frame: Weeks 2, 10 and 22.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT07058389 · 25CH062 · 2025-A00700-49

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗