CopdPARACHUTENCT03793452
Effect of Pulmonary Rehabilitation on Fear of Falling in COPD Patients
An observational study of Copd, run by University Hospital, Brest at 1 site in France.
Trial summary
The aim of this study is to measure the impact of pulmonary rehabilitation program on fear of falling in COPD patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2019to 18 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients admitted for pulmonary rehabilitation program in pulmonary rehabilitation unit of CH des Pays de Morlaix
Who may be able to join
- COPD patients
Who cannot join
- post surgical rehabilitation
- neurologic or orthopedic disorders limiting walking
- imbalance disorders
- inability to answer to the questionnaire
- refusal to participate.
- inability to perform the pulmonary rehabilitation program.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to measure the impact of pulmonary rehabilitation program on fear of falling in COPD patients
- Conditions
- Copd
- Keywords
- COPD, pulmonary rehabilitation, fear of falling, evaluation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of fear of falling after a pulmonary rehabilitation
measure of fear of falling (FES-I) before and after a pulmonary rehabilitation program
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start18 Jan 2019
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Beaumont, PhD, Principal investigator, CH DES PAYS DE MORLAIX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793452
- Sponsor's protocol ID
- PARACHUTE (29BRC18.0246)
- Acronym
- PARACHUTE
- Status last verified
- Jul 2020
- First submitted
- 2 Jan 2019
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berriet AC, Beaumont M, Peran L, Le Ber C, Couturaud F. Effects of pulmonary rehabilitation on fear of falling in Chronic Obstructive Pulmonary Disease (COPD) patients: An observational study. Respir Med Res. 2022 Nov;82:100932. doi: 10.1016/j.resmer.2022.100932. Epub 2022 Jun 12.
PubMed 35878569
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulmonary Rehabilitation on Fear of Falling in COPD Patients
- ClinicalTrials.gov ID
- NCT03793452
- Acronym / sponsor ID
- PARACHUTE / PARACHUTE (29BRC18.0246)
- Conditions
- Copd
- Keywords
- COPD, pulmonary rehabilitation, fear of falling, evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 4 Jan 2019 (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.
The aim of this study is to measure the impact of pulmonary rehabilitation program on fear of falling in COPD patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients admitted for pulmonary rehabilitation program in pulmonary rehabilitation unit of CH des Pays de Morlaix
Key inclusion criteria (1 listed)
- COPD patients
Key exclusion criteria (6 listed)
- post surgical rehabilitation
- neurologic or orthopedic disorders limiting walking
- imbalance disorders
- inability to answer to the questionnaire
- refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measure of fear of falling after a pulmonary rehabilitation
Time frame: 4 weeks
measure of fear of falling (FES-I) before and after a pulmonary rehabilitation program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Derived from this study: PubMed 35878569Berriet AC, Beaumont M, Peran L, Le Ber C, Couturaud F. Effects of pulmonary rehabilitation on fear of falling in Chronic Obstructive Pulmonary Disease (COPD) patients: An observational study. Respir Med Res. 2022 Nov;82:100932. doi: 10.1016/j.resmer.2022.100932. Epub 2022 Jun 12.
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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.
Marc Beaumont, PhD principal investigator
CH DES PAYS DE MORLAIX
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 Copd, run by University Hospital, Brest 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 16 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure of fear of falling after a pulmonary rehabilitation (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03793452, which also lists 1 linked publication.
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 16 Jul 2020.