Schizoaffective DisorderSAPINNCT07058389
Synergy Between Physical Activity and Outdoor Green Environments to Reduce the Intensity of Negative Symptoms in Schizophrenia.
A study testing 8-week outdoor physical activity program and 8-week indoor physical activity program in people with Schizoaffective Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizoaffective Disorder
- What is being tested?
- 8-week outdoor physical activity program and 8-week indoor physical activity program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, France, 42055
Medhi HOUSNI, Md, (0)477127885 ext. +33, Medhi.Housni@chu-st-etienne.fr
Medhi HOUSNI, Md
About this study
Official title: 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.
- Conditions
- Schizoaffective Disorder
- Being tested
- 8-week outdoor physical activity program, 8-week indoor physical activity program
- Keywords
- Schizophrenia disorders, Mental health, Quality of life, Physical fitness
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-week outdoor physical activity programOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| INT group | Experimental | 8-week indoor physical activity program (in a gymnasium) Receives: Other: 8-week indoor physical activity program |
| EXT group | Experimental | 8-week outdoor physical activity program Receives: Other: 8-week outdoor physical activity program |
| TEM group | No intervention | Without physical activiy program (no change in routine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 2, 10 and 22
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 2, 10 and 22.
Maximum force
The maximum force produced by the knee extensors will be measured on a dynamometer.
Measured: Weeks 2, 10 and 22.
Flexibility
Flexibility of the posterior chain will be measured with the sit and reach test.
Measured: Weeks 2, 10 and 22.
Spatio-temporal coordination
Spatio-temporal coordination will be assessed by measuring individual reaction times.
Measured: Weeks 2, 10 and 22.
Balance
Balance will be tested by stabilometry on a Winposturo force platform.
Measured: 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.
Measured: Weeks 2, 10 and 22.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start7 Oct 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizoaffective DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jean Monnet University
- Responsible party
- Sponsor
- Investigators
- Medhi HOUSNI, Md, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058389
- Sponsor's protocol ID
- 25CH062
- Other IDs
- 2025-A00700-49
- Acronym
- SAPIN
- Status last verified
- Nov 2025
- First submitted
- 30 Jun 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergy Between Physical Activity and Outdoor Green Environments to Reduce the Intensity of Negative Symptoms in Schizophrenia: a Pilot Study.
- ClinicalTrials.gov ID
- NCT07058389
- Acronym / sponsor ID
- SAPIN / 25CH062
- Conditions
- Schizoaffective Disorder
- Keywords
- Schizophrenia disorders, Mental health, Quality of life, Physical fitness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Jean Monnet University
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| INT group | Experimental | Other: 8-week indoor physical activity program8-week indoor physical activity program (in a gymnasium) |
| EXT group | Experimental | Other: 8-week outdoor physical activity program8-week outdoor physical activity program |
| TEM group | No intervention | –Without physical activiy program (no change in routine) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8-week outdoor physical activity programEXT 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 | EXT group |
| 8-week indoor physical activity programINT 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. | Other | INT group |
Primary outcome
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.
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medhi HOUSNI, Md principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-week outdoor physical activity program and 8-week indoor physical activity program in people with Schizoaffective Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medhi HOUSNI, Md ((0)477127885 ext. +33, Mehdi.Housni@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-evaluation of negative symptoms (SNS) questionnaire (time frame: Weeks 2, 10 and 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.