Analysis of Postural Control of COPD Patients (ATTRACTION) (ATTRACTION)

January 14, 2022 updated by: Graziella Brinchault, University of Rennes 2

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COPD patients that realize their medical follow-up at University Hospital of Rennes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. the presence of long-term or exercise-based oxygen therapy,
  2. the presence of a medically diagnosed pathology causing manifest disorders of balance,
  3. the inability to walk 150 m without stopping and to climb or descend stairs,
  4. a history of pneumonectomy or lobectomy within the last six months,
  5. the existence of an acute respiratory exacerbation within the last two months,
  6. the presence of obvious cognitive impairment that impairs comprehension of instructions,
  7. body mass index less than 21 or more than 35 kg/m².

  8. 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
  9. Person under psychiatric care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy controls
Other: quantified analysis of postural control during activities of daily living
functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)
COPD patients
Other: quantified analysis of postural control during activities of daily living
functional tests that reproduce tasks of daily living (timed up and go test with and without dual cognitive task, modified Glittre ADL test)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Clinical assessment at baseline
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
Clinical assessment at baseline
Center of Mass velocity
Time Frame: Clinical assessment at baseline
Parameter of participant's Centre of Mass (CoM) during the functional tests
Clinical assessment at baseline
Center of mass displacement
Time Frame: Clinical assessment at baseline
Parameter of participant's Centre of Mass (CoM) during the functional tests
Clinical assessment at baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evolution of articular angulations
Time Frame: Clinical assessment at baseline
Articular angulations assessed at the ankle, knee, hip, spine and thoracic level during the functional tests
Clinical assessment at baseline
Centre of pressure (CoP) Area
Time Frame: Clinical assessment at baseline
Parameter of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
Clinical assessment at baseline
Centre of pressure (CoP) velocity
Time Frame: Clinical assessment at baseline
Parameter of participant's Centre of Pressure (CoP) during the sit to stand and stand to sit tasks of the Glittre-ADL test
Clinical assessment at baseline
Centre of pressure (CoP) variability
Time Frame: Clinical assessment at baseline
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
Clinical assessment at baseline
Gait Cadence
Time Frame: Clinical assessment at baseline
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Clinical assessment at baseline
Gait velocity
Time Frame: Clinical assessment at baseline
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Clinical assessment at baseline
Gait phases duration
Time Frame: Clinical assessment at baseline
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Clinical assessment at baseline
Step width
Time Frame: Clinical assessment at baseline
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Clinical assessment at baseline
Step length
Time Frame: Clinical assessment at baseline
spatio-temporal parameter of gait assessed during the walking part of the Glittre-ADL test
Clinical assessment at baseline
Completion time of the Modified Glittre ADL
Time Frame: Clinical assessment at baseline
Time to complete the modified Glittre-ADL test
Clinical assessment at baseline
Completion time of the timed up and go test
Time Frame: Clinical assessment at baseline
Time to complete the timed up and go test test
Clinical assessment at baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dyspnea assessment scale
Time Frame: Clinical assessment at baseline
assessed by the modified Borg Scale which is a 0 to 10 scale (0 representing no dyspnea, 10 representing the worst imaginable dyspnea). Dyspnea is assessed before, during and after the functional tests
Clinical assessment at baseline
Heart rate
Time Frame: Clinical assessment at baseline
assessed before, during and after functional tests
Clinical assessment at baseline
Leg discomfort scale
Time Frame: Clinical assessment at baseline
assessed on a 0 to 10 scale (0 representing no discomfort, 10 representing the worst imaginable discomfort).Leg discomfort is assessed before, during and after the functional tests
Clinical assessment at baseline
Visual analog scale for pain
Time Frame: Clinical assessment at baseline
Pain is assessed by a visual analog scale which is a 100mm long horizontal line with verbal descriptors at each end to express the extremes of the feeling (Here no pain and the worst imaginable pain)
Clinical assessment at baseline
Pain Drawing scale
Time Frame: Clinical assessment at baseline
participants are invited to identify on a body chart the location of experienced pain.
Clinical assessment at baseline
Multi-dimensional dyspnea profile (MDP)
Time Frame: Clinical assessment at baseline
Dyspnea assessment tool which investigates sensory and affective dimensions of dyspnea
Clinical assessment at baseline
London chest activity of daily living questionnaire (LCADL)
Time Frame: Clinical assessment at baseline
Dyspnea assessment tool which investigates the impact of dyspnea on 15 activities of daily living. A score from 0 to 5 is given for each activity, 5 representing an higher impact of dyspnea on the activity.
Clinical assessment at baseline
Modified Medical Research Council Scale (MMRC)
Time Frame: Clinical assessment at baseline
Dyspnea assessment tool which investigates impact of dyspnea in participants life. This is a 0 to 4 scale with descriptors associated to each number. 4 representing the most severe impact of dyspnea.
Clinical assessment at baseline
Charlson Index
Time Frame: Clinical assessment at baseline
Comorbidities assessment tool which list 19 potential comorbidities associated with a weighted score. The points are attributed when the comorbidity is present. A total score is then calculated. An higher score indicates an higher severity.
Clinical assessment at baseline
Body composition
Time Frame: Clinical assessment at baseline
Determination of fat free mass and fat mass by bioelectrical impedance analysis.
Clinical assessment at baseline
Maximal inspiratory pressure
Time Frame: Clinical assessment at baseline
inspiratory muscles strength assessment
Clinical assessment at baseline
Falls Efficacy Scale - International
Time Frame: Clinical assessment at baseline
Fear of falling assessment tool which investigates fear of falling in 16 different activities. Each activity is scored from 0 to 4 (4 representing an higher fear of falling in this activity). The total score range from 16 to 64 (an higher score indicating a most severe fear of falling)
Clinical assessment at baseline
Number of anterior falls
Time Frame: Clinical assessment at baseline
assessment of fall occurence in the last 12 months
Clinical assessment at baseline
General Practioner assessment of Cognition (GP-COG)
Time Frame: Clinical assessment at baseline
assessment of cognitive function. GP-COG gives a score from 0 to 9 (9 indicating a better cognitive function)
Clinical assessment at baseline
International Physical Activity Questionnaire (IPAQ short-form)
Time Frame: Clinical assessment at baseline
assessment of daily physical activity and sedentarity
Clinical assessment at baseline
COPD assessment test (CAT)
Time Frame: Clinical assessment at baseline
quality of life assessment tool
Clinical assessment at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rennes 2

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rennes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Graziella Brinchault, MD, University Hospital of Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2S-ATTRACTION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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