The Impact of Outdoor Sports Practice on the Well-Being o... | NCT06040450

Studies
The Impact of Outdoor Sports Practice on the Well-Being of Disabled People

NCT06040450

Sponsor

Institut de Sante Parasport Connecte Synergies

Status

Unknown status

Last Update Posted

Oct 10, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Disability or Chronic Disease Leading to Disablement

Interventions

Questionnaire survey

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2023Actual

Primary Completion Date

Nov 30, 2023Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Sep 7, 2023

First Submission Date that Met QC Criteria

Sep 13, 2023

First Posted Date

Sep 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2023

Last Update Posted Date

Oct 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Institut de Sante Parasport Connecte SynergiesOTHER

Collaborators

Name	Class
Fédération Française Handisport (FFH)	UNKNOWN
Université de Montpellier - UMR Santé, Education et Situations de Handicap (SANTESIH)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All subjects with impairments			Other: Questionnaire survey
All subjects without impairments			Other: Questionnaire survey

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire survey	Other	On outdoor sports practice activity, barriers to practice, impacts on well-being.	All subjects with impairments All subjects without impairments

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impact of my outdoor sports on my well-being	Rating Scale : 1 (low) to 10 (high)	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Impact of my outdoor sports on my self-esteem	Rating Scale : 1 (low) to 10 (high)	Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Being a member of the French Handisport Federation between September 2022 and August 2023
Practicing outdoor sports

Exclusion Criteria:

Persons who have objected to be contacted by e-mail

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Members of the French Handisport Federation practicing outdoor sports

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vincent T. Carpentier, MD-MSc	Contact	+33 1 47 10 70 82		vincent.carpentier@ispc-synergies.org

Overall Officials

Name	Affiliation	Role
Vincent T. Carpentier, MD-MSc	Institut de Sante Parasport Connecte Synergies	Study Director
Eric Perera, PhD	Montpellier University - SANTESIH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
French Handisport Federation	Recruiting	Paris			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009043	Motor Activity

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided