Chronic Obstructive Pulmonary DiseaseATTRACTIONNCT05211674
Analysis of Postural Control of COPD Patients (ATTRACTION)
An observational study of Chronic Obstructive Pulmonary Disease, run by University of Rennes 2.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease, causing disabling respiratory symptoms and impairing patients' quality of life. Currently one of the leading causes of death worldwide, COPD is a major socio-economic concern. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Apr 2023
- 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: COPD patients that realize their medical follow-up at University Hospital of Rennes
Who may be able to join
- COPD patients GOLD stage 2 and 3 (A-D)
- In accordance with Article L1121-8-1 of the Public Health Code, participants must be affiliated to a social security scheme or benefit from such a scheme.
Who cannot join
- the presence of long-term or exercise-based oxygen therapy,
- the presence of a medically diagnosed pathology causing manifest disorders of balance,
- the inability to walk 150 m without stopping and to climb or descend stairs,
- a history of pneumonectomy or lobectomy within the last six months,
- the existence of an acute respiratory exacerbation within the last two months,
- the presence of obvious cognitive impairment that impairs comprehension of instructions,
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- body mass index less than 21 or more than 35 kg/m².
- Person referred to in articles L. 1121-5 to L. 1121-8 and L. 1121-12 of the public health code:
- Pregnant woman, woman in labour or nursing mother
- Person deprived of liberty by judicial or administrative decision
- Person hospitalised without consent and not subject to a legal protection measure, and person admitted to a health or social establishment for purposes other than research
- Minor
- Person subject to a period of exclusion for other research
- Person of full age subject to a legal protection measure (guardianship, curatorship or safeguard of justice), person of full age unable to express their consent and not subject to a protection measure
- Person under psychiatric care
Trial locations and contacts
No sites are listed yet.
Armel Cretual, PhD contact
About this study
Official title: Quantified Analysis of Postural Control of COPD Patients During Tasks of Daily Living
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease, causing disabling respiratory symptoms and impairing patients' quality of life. Currently one of the leading causes of death worldwide, COPD is a major socio-economic concern. It is also accompanied by extremely frequent extra-respiratory manifestations (or co-morbidities). Among these secondary manifestations, the equilibrium of these patients is subject to modifications: thus, numerous studies have shown that the equilibrium of COPD patients was altered compared to healthy age-matched subjects. This alteration is associated with a greater functional limitation and a higher risk of falling. Although this impairment has been demonstrated clinically, the balance of these patients has never been analysed using quantified movement analysis tools during tasks similar to those performed in daily life. Moreover, the underlying mechanisms remain unknown and the possible associations with several clinical factors of interest (pain, dyspnea, muscle function...) have not yet been assessed. The hypotheses of this project are that (1) the postural control of COPD patients is altered compared to healthy subjects during tasks of daily living and these changes can be characterised. (2) Several clinical factors are associated with these changes.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- quantified analysis of postural control during activities of daily living
- Keywords
- chronic obstructive pulmonary disease, postural balance, activities of daily living
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quantified analysis of postural control during activities of daily livingOther
functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Not described Receives: Other: quantified analysis of postural control during activities of daily living | |
| Healthy controls | Not described Receives: Other: quantified analysis of postural control during activities of daily living |
What is being measured
The primary outcome is the main question the study is designed to answer.
Margins of stability
Postural control parameter related to the centre of mass (CoM) and the base of support of the participant, assessed during the functional tests
Measured: Clinical assessment at baseline
Margins of stability variability
Coefficient of variation of a postural control parameter related to the centre of mass (CoM) and the base of support of the participant, assessed during the functional tests
Measured: Clinical assessment at baseline
Center of Mass velocity
Parameter of participant's Centre of Mass (CoM) during the functional tests
Measured: Clinical assessment at baseline
Center of mass displacement
Parameter of participant's Centre of Mass (CoM) during the functional tests
Measured: Clinical assessment at baseline
Secondary outcomes (11)
Evolution of articular angulations
Articular angulations assessed at the ankle, knee, hip, spine and thoracic level during the functional tests
Measured: Clinical assessment at baseline
Centre of pressure (CoP) Area
Parameter of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
Measured: Clinical assessment at baseline
Centre of pressure (CoP) velocity
Parameter of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
Measured: Clinical assessment at baseline
Centre of pressure (CoP) variability
Coefficient of variation of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
Measured: Clinical assessment at baseline
Gait Cadence
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Measured: Clinical assessment at baseline
Gait velocity
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Measured: Clinical assessment at baseline
Gait phases duration
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Measured: Clinical assessment at baseline
Step width
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Measured: Clinical assessment at baseline
Step length
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Measured: Clinical assessment at baseline
Completion time of the Modified Glittre ADL
Time to complete the modified Glittre-ADL test
Measured: Clinical assessment at baseline
Completion time of the timed up and go test
Time to complete the timed up and go test test
Measured: Clinical assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study startFeb 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rennes 2
- Sponsor type
- University, hospital or other
- Collaborators
- Rennes University Hospital
- Responsible party
- Principal investigator, Graziella Brinchault, Rennes University Hospital
- Investigators
- Graziella Brinchault, MD, Principal investigator, University Hospital of Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211674
- Sponsor's protocol ID
- M2S-ATTRACTION
- Acronym
- ATTRACTION
- Status last verified
- Jan 2022
- First submitted
- 23 Nov 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantified Analysis of Postural Control of COPD Patients During Tasks of Daily Living
- ClinicalTrials.gov ID
- NCT05211674
- Acronym / sponsor ID
- ATTRACTION / M2S-ATTRACTION
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, postural balance, activities of daily living
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Rennes 2University, hospital or other
- Collaborators
- Rennes University Hospital
- Study start
- Feb 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 27 Jan 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.
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease, causing disabling respiratory symptoms and impairing patients' quality of life. Currently one of the leading causes of death worldwide, COPD is a major socio-economic concern. It is also accompanied by extremely frequent extra-respiratory manifestations (or co-morbidities). Among these secondary manifestations, the equilibrium of these patients is subject to modifications: thus, numerous studies have shown that the equilibrium of COPD patients was altered compared to healthy age-matched subjects. This alteration is associated with a greater functional limitation and a higher risk of falling. Although this impairment has been demonstrated clinically, the balance of these patients has never been analysed using quantified movement analysis tools during tasks similar to those performed in daily life. Moreover, the underlying mechanisms remain unknown and the possible associations with several clinical factors of interest (pain, dyspnea, muscle function...) have not yet been assessed. The hypotheses of this project are that (1) the postural control of COPD patients is altered compared to healthy subjects during tasks of daily living and these changes can be characterised. (2) Several clinical factors are associated with these changes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Other: quantified analysis of postural control during activities of daily living |
| Healthy controls | – | Other: quantified analysis of postural control during activities of daily living |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- COPD patients that realize their medical follow-up at University Hospital of Rennes
Key inclusion criteria (2 listed)
- COPD patients GOLD stage 2 and 3 (A-D)
- In accordance with Article L1121-8-1 of the Public Health Code, participants must be affiliated to a social security scheme or benefit from such a scheme.
Key exclusion criteria (15 listed)
- the presence of long-term or exercise-based oxygen therapy,
- the presence of a medically diagnosed pathology causing manifest disorders of balance,
- the inability to walk 150 m without stopping and to climb or descend stairs,
- a history of pneumonectomy or lobectomy within the last six months,
- the existence of an acute respiratory exacerbation within the last two months,
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 |
|---|---|---|
| quantified analysis of postural control during activities of daily livingfunctional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test) | Other | COPD patients, Healthy controls |
Primary outcome
Margins of stability
Time frame: Clinical assessment at baseline
Postural control parameter related to the centre of mass (CoM) and the base of support of the participant, assessed during the functional tests
Margins of stability variability
Time frame: Clinical assessment at baseline
Coefficient of variation of a postural control parameter related to the centre of mass (CoM) and the base of support of the participant, assessed during the functional tests
Center of Mass velocity
Time frame: Clinical assessment at baseline
Parameter of participant's Centre of Mass (CoM) during the functional tests
Center of mass displacement
Time frame: Clinical assessment at baseline
Parameter of participant's Centre of Mass (CoM) during the functional tests
11 secondary outcomes
Evolution of articular angulations
Time frame: Clinical assessment at baseline
Centre of pressure (CoP) Area
Time frame: Clinical assessment at baseline
Centre of pressure (CoP) velocity
Time frame: Clinical assessment at baseline
Centre of pressure (CoP) variability
Time frame: Clinical assessment at baseline
Gait Cadence
Time frame: Clinical assessment at baseline
Gait velocity
Time frame: Clinical assessment at baseline
Gait phases duration
Time frame: Clinical assessment at baseline
Step width
Time frame: Clinical assessment at baseline
Step length
Time frame: Clinical assessment at baseline
Completion time of the Modified Glittre ADL
Time frame: Clinical assessment at baseline
Completion time of the timed up and go test
Time frame: Clinical assessment at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
Armel Cretual, PhD contact
Graziella Brinchault, MD principal investigator
University Hospital of Rennes
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by University of Rennes 2.
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 15 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 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Romain Pichon, MSc (0667774267, r.pichon@ifpek.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Margins of stability (time frame: Clinical assessment at baseline). The study lists 4 primary outcomes in all. 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 27 Jan 2022.