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NCT Number: NCT07058389

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

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.

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Key information

Conditions

Schizoaffective Disorder Behavior Mental Disorders Personal Satisfaction Psychological Well-Being Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, France, 42055

Location status: Recruiting

Location contact

Medhi HOUSNI, Md

CONTACT

[email protected]

(0)477127885 ext. +33

Medhi HOUSNI, Md

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Self-evaluation of negative symptoms (SNS) questionnaire

    Time frame: Weeks 2, 10 and 22

    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.

Secondary outcomes

  1. Clinical global Impression (CGI) scale

    Time frame: Weeks 2, 10 and 22

    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).

  2. Personal and social performance (PSP) scale

    Time frame: Weeks 2, 10 and 22

    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.

  3. Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)

    Time frame: Weeks 2, 10 and 22.

    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.

  4. VO2 max

    Time frame: Weeks 2, 10 and 22.

    VO2 max will be estimated on the basis of heart rate measured during a submaximal test on an ergonomic bicycle.

  5. Maximum force

    Time frame: Weeks 2, 10 and 22.

    The maximum force produced by the knee extensors will be measured on a dynamometer.

  6. Flexibility

    Time frame: Weeks 2, 10 and 22.

    Flexibility of the posterior chain will be measured with the sit and reach test.

  7. Spatio-temporal coordination

    Time frame: Weeks 2, 10 and 22.

    Spatio-temporal coordination will be assessed by measuring individual reaction times.

  8. Balance

    Time frame: Weeks 2, 10 and 22.

    Balance will be tested by stabilometry on a Winposturo force platform.

  9. IPAQ questionnaire

    Time frame: Weeks 2, 10 and 22.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Medhi HOUSNI, Md

CONTACT

[email protected]

(0)477127885 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Jean Monnet University

Registry information

Official study title

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

Acronym: SAPIN

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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