Disability or Chronic Disease Leading to DisablementNCT06040450
The Impact of Outdoor Sports Practice on the Well-Being of Disabled People
An observational study of Disability or Chronic Disease Leading to Disablement, run by Institut de Sante Parasport Connecte Synergies at 1 site in France.
Trial summary
Survey of the members of the French Handisports Federation (FFH) practicing outdoor sports. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Disability or Chronic Disease Leading to Disablement
- What is being tested?
- Questionnaire survey
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Members of the French Handisport Federation practicing outdoor sports
Who may be able to join
- Being a member of the French Handisport Federation between September 2022 and August 2023
- Practicing outdoor sports
Who cannot join
- Persons who have objected to be contacted by e-mail
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
French Handisport Federation
Paris
Emmanuel Buchoud
About this study
Official title: The Impact of Outdoor Sports Practice on the Well-Being of Disabled People : a Cross-Sectional Study
Survey of the members of the French Handisports Federation (FFH) practicing outdoor sports.
Read the detailed description
This is a national cross-sectional study to investigate the impact of outdoor sports practice on the well-being and self-esteem of people with disabilities.
The study is based on a survey of FFH members practicing outdoor sports. The survey will be distributed between October and November 2023 via the federation's internal communication system. Data will be collected on outdoor sports activity, psychological impact and barriers to practice.
Analyses will be made between able-bodied and disabled members, between types of disability, and between types of outdoor sport practiced (water, land and air).
Analysis will be based on anomysed data and will respect the MR004 methodology.
- Being tested
- Questionnaire survey
- Keywords
- Physical activities, Outdoor sports, Disability
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire surveyOther
On outdoor sports practice activity, barriers to practice, impacts on well-being.
| Study group | Role | What they receive |
|---|---|---|
| All subjects with impairments | Not described Receives: Other: Questionnaire survey | |
| All subjects without impairments | Not described Receives: Other: Questionnaire survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of my outdoor sports on my well-being
Rating Scale : 1 (low) to 10 (high)
Measured: Baseline
Secondary outcomes (1)
Impact of my outdoor sports on my self-esteem
Rating Scale : 1 (low) to 10 (high)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start25 Sep 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability or Chronic Disease Leading to DisablementStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Sante Parasport Connecte Synergies
- Sponsor type
- University, hospital or other
- Collaborators
- Fédération Française Handisport (FFH), Université de Montpellier - UMR Santé, Education et Situations de Handicap (SANTESIH)
- Responsible party
- Sponsor
- Investigators
- Vincent T. Carpentier, MD-MSc, Study director, Institut de Sante Parasport Connecte SynergiesEric Perera, PhD, Study director, Montpellier University - SANTESIHEmmanuel Buchoud, Study director, French Handisport Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040450
- Sponsor's protocol ID
- 2023-004
- Status last verified
- Oct 2023
- First submitted
- 7 Sep 2023
- Last updated
- 10 Oct 2023
- 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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Outdoor Sports Practice on the Well-Being of Disabled People : a Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06040450
- Acronym / sponsor ID
- 2023-004
- Keywords
- Physical activities, Outdoor sports, Disability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institut de Sante Parasport Connecte SynergiesUniversity, hospital or other
- Collaborators
- Fédération Française Handisport (FFH), Université de Montpellier - UMR Santé, Education et Situations de Handicap (SANTESIH)
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Sep 2023 (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.
Survey of the members of the French Handisports Federation (FFH) practicing outdoor sports.
Detailed description
This is a national cross-sectional study to investigate the impact of outdoor sports practice on the well-being and self-esteem of people with disabilities.
The study is based on a survey of FFH members practicing outdoor sports. The survey will be distributed between October and November 2023 via the federation's internal communication system. Data will be collected on outdoor sports activity, psychological impact and barriers to practice.
Analyses will be made between able-bodied and disabled members, between types of disability, and between types of outdoor sport practiced (water, land and air).
Analysis will be based on anomysed data and will respect the MR004 methodology.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All subjects with impairments | – | Other: Questionnaire survey |
| All subjects without impairments | – | Other: Questionnaire survey |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Members of the French Handisport Federation practicing outdoor sports
Key inclusion criteria (2 listed)
- Being a member of the French Handisport Federation between September 2022 and August 2023
- Practicing outdoor sports
Key exclusion criteria (1 listed)
- Persons who have objected to be contacted by e-mail
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 |
|---|---|---|
| Questionnaire surveyOn outdoor sports practice activity, barriers to practice, impacts on well-being. | Other | All subjects with impairments, All subjects without impairments |
Primary outcome
Impact of my outdoor sports on my well-being
Time frame: Baseline
Rating Scale : 1 (low) to 10 (high)
1 secondary outcome
Impact of my outdoor sports on my self-esteem
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- 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. This study is not recruiting at the moment.
Vincent T. Carpentier, MD-MSc study director
Institut de Sante Parasport Connecte Synergies
Eric Perera, PhD study director
Montpellier University - SANTESIH
Emmanuel Buchoud study director
French Handisport Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disability or Chronic Disease Leading to Disablement, run by Institut de Sante Parasport Connecte Synergies 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent T. Carpentier, MD-MSc (+33 1 47 10 70 82, vincent.carpentier@ispc-synergies.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of my outdoor sports on my well-being (time frame: Baseline). 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 10 Oct 2023.