NCT05294068

Brief Summary

People with disabilities are less physically active than the general population. Their barriers to physical activity are multiple and include intrapersonal, organizational, societal and interpersonal reasons. Nevertheless, at present, the evolution of their barriers to physical activity and the short- and long-term impact of medical and medico-social treatments to limit them are unknown. The aim of this study is to describe barriers to physical activity, or disability-related underperformance factors in competitive sports, in patients with cognitive, neuromotor or sensory impairments during aging.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
94mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Apr 2022Feb 2034

First Submitted

Initial submission to the registry

January 5, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2032

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2034

Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

9.8 years

First QC Date

January 5, 2022

Last Update Submit

April 15, 2023

Conditions

Keywords

Physical activitiesBarriersDisability

Outcome Measures

Primary Outcomes (1)

  • Changes of barriers to physical activity during aging

    Questionnaires assessing barriers and facilitators to physical activity (ex: BPAQ)

    through study completion, an average of 1 year

Secondary Outcomes (6)

  • Changes of physical activity level during aging

    through study completion, an average of 1 year

  • Characteristics of medical and medico-social therapies implemented to limit barriers to physical activity

    through study completion, an average of 1 year

  • Characteristics of the medical and medico-social therapies implemented to limit disability-related underperformance factors for competitive sports

    through study completion, an average of 1 year

  • Characteristics of devices (orthoses, prostheses, etc.) and technical aids used to facilitate the practice of physical activity

    through study completion, an average of 1 year

  • Evolution of comorbidities during aging

    through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (3)

All subjects with cognitive impairments

Other: standard of care for patients with cognitive impairments

All subjects with neuromotor impairments

Other: standard of care for patients with neuromotor impairments

All subjects with sensory impairments

Other: standard of care for patients with sensory impairments

Interventions

clinical examination, radiological, biological and physiological examinations.

All subjects with cognitive impairments

clinical examination, radiological, biological and physiological examinations.

All subjects with neuromotor impairments

clinical examination, radiological, biological and physiological examinations.

All subjects with sensory impairments

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with cognitive, neuromotor or sensory impairments.

You may qualify if:

  • Patients \>= 6 years old ;
  • Consulting to the Parasport Health Unit of the Physical Medicine and Rehabilitation Department of our university hospital ;
  • Having a neuromotor, cognitive or sensory impairment ;
  • No opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it, or from each of the holders of parental authority if a minor ;
  • Affiliation to a social security scheme.

You may not qualify if:

  • Under court protection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP

Garches, 92380, France

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • François Genêt, MD-PhD

    Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

    PRINCIPAL INVESTIGATOR
  • Vincent T Carpentier, MD-MSc

    Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

    STUDY DIRECTOR

Central Study Contacts

François Genêt, MD-PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

March 24, 2022

Study Start

April 1, 2022

Primary Completion (Estimated)

February 1, 2032

Study Completion (Estimated)

February 1, 2034

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations