Disability or Chronic Disease Leading to DisablementNO-BARRIERSNCT05294068
Barriers to Physical Activity in Patients With Cognitive, Neuromotor or Sensory Impairments During Aging
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
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Disability or Chronic Disease Leading to Disablement
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2022to 1 Feb 2034
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with cognitive, neuromotor or sensory impairments.
Who may be able to join
- 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.
Who cannot join
- Under court protection.
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
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP
Garches, 92380
Vincent T. Carpentier
François Genêt
About this study
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.
Read the detailed description
This is an ambispective, monocentric, cohort study of subjects with cognitive, neuromotor or sensory impairments followed in a Physical Medicine and Rehabilitation Department.
All consecutive eligible outpatient subjects consulting to the Parasport Health Unit of the Physical Medicine and Rehabilitation Department of our university hospital will be included. Clinical activities related to the Parasport Health Unit and performed outside the hospital will also be included.
Data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological and physiological examinations.
- Being tested
- standard of care for patients with cognitive impairments, standard of care for patients with neuromotor impairments, standard of care for patients with sensory impairments
- Keywords
- Physical activities, Barriers, 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.
standard of care for patients with cognitive impairmentsOther
clinical examination, radiological, biological and physiological examinations.
standard of care for patients with neuromotor impairmentsOther
clinical examination, radiological, biological and physiological examinations.
standard of care for patients with sensory impairmentsOther
clinical examination, radiological, biological and physiological examinations.
| Study group | Role | What they receive |
|---|---|---|
| All subjects with cognitive impairments | Not described Receives: Other: standard of care for patients with cognitive impairments | |
| All subjects with neuromotor impairments | Not described Receives: Other: standard of care for patients with neuromotor impairments | |
| All subjects with sensory impairments | Not described Receives: Other: standard of care for patients with sensory impairments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of barriers to physical activity during aging
Questionnaires assessing barriers and facilitators to physical activity (ex: BPAQ)
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Changes of physical activity level during aging
Questionnaires assessing physical activity levels (ex: PASPID)
Measured: through study completion, an average of 1 year
Characteristics of medical and medico-social therapies implemented to limit barriers to physical activity
Number and description of medical and medico-social therapies
Measured: 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
Number and description of medical and medico-social therapies
Measured: 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
Number and description of devices (orthoses and prostheses) and technical aids
Measured: through study completion, an average of 1 year
Evolution of comorbidities during aging
Prevalence of comorbidities (e.g. obesity, diabetes, hypertension, sleep apnea, ...)
Measured: through study completion, an average of 1 year
Evolution of exercise stress tests results during aging
Stress tests results
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Apr 2022
- Primary completion1 Feb 2032 (estimated)
- Study completion1 Feb 2034 (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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Institut de Sante Parasport Connecte Synergies
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- François Genêt, MD-PhD, Principal investigator, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, FranceVincent T Carpentier, MD-MSc, Study director, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294068
- Sponsor's protocol ID
- 2022-001
- Acronym
- NO-BARRIERS
- Status last verified
- Apr 2023
- First submitted
- 5 Jan 2022
- Last updated
- 19 Apr 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 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers to Physical Activity in Patients With Cognitive, Neuromotor or Sensory Impairments During Aging
- ClinicalTrials.gov ID
- NCT05294068
- Acronym / sponsor ID
- NO-BARRIERS / 2022-001
- Keywords
- Physical activities, Barriers, Disability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institut de Sante Parasport Connecte SynergiesUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Feb 2032 (estimated)
- Study completion
- 1 Feb 2034 (estimated)
- First posted
- 24 Mar 2022 (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.
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.
Detailed description
This is an ambispective, monocentric, cohort study of subjects with cognitive, neuromotor or sensory impairments followed in a Physical Medicine and Rehabilitation Department.
All consecutive eligible outpatient subjects consulting to the Parasport Health Unit of the Physical Medicine and Rehabilitation Department of our university hospital will be included. Clinical activities related to the Parasport Health Unit and performed outside the hospital will also be included.
Data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological and physiological examinations.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with cognitive, neuromotor or sensory impairments.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Under court protection.
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 |
|---|---|---|
| standard of care for patients with cognitive impairmentsclinical examination, radiological, biological and physiological examinations. | Other | All subjects with cognitive impairments |
| standard of care for patients with neuromotor impairmentsclinical examination, radiological, biological and physiological examinations. | Other | All subjects with neuromotor impairments |
| standard of care for patients with sensory impairmentsclinical examination, radiological, biological and physiological examinations. | Other | All subjects with sensory impairments |
Primary outcome
Changes of barriers to physical activity during aging
Time frame: through study completion, an average of 1 year
Questionnaires assessing barriers and facilitators to physical activity (ex: BPAQ)
6 secondary outcomes
Changes of physical activity level during aging
Time frame: through study completion, an average of 1 year
Characteristics of medical and medico-social therapies implemented to limit barriers to physical activity
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 1 year
Evolution of comorbidities during aging
Time frame: through study completion, an average of 1 year
Evolution of exercise stress tests results during aging
Time frame: through study completion, an average of 1 year
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 19 Apr 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.
François Genêt, MD-PhD principal investigator
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
Vincent T Carpentier, MD-MSc study director
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
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 5 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: looking for participants now, as of the sponsor's last update on 19 Apr 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?
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 François Genêt, MD-PhD (+33 1 47 10 70 82, francois.genet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of barriers to physical activity during aging (time frame: through study completion, an average of 1 year). 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 19 Apr 2023.