NCT04279730

Brief Summary

Patients with COPD benefit from pulmonary rehabilitation (PR), but a ceiling effect of performance (ie. absence of additional exercise tolerance increase) is observed in 80% of patients from only 20 sessions. An imbalance between intensity, duration and frequency of PR sessions, leading to fatigue development in the course of the PR, could explain this ceiling effect. However, previous studies having evaluated the impact of a PR program on fatigue scores reported either a decrease or no changing, but never an increase. To date, no study has evaluated intermediate variations of fatigue score during a PR program, but were limited to a pre-post PR assessment. Therefore, fatigue fluctuations during PR are unknown. Furthermore, most studies had only unidimensional fatigue assessment. Since fatigue is a multifactorial and a multidimensional process, it cannot be accurately estimated through a unique assessment. Given that most of COPD patients do not increase their exercise tolerance from 20 PR sessions, the investigators hypothesize a significant increase of multidimensional fatigue score between the 1st and the 20th PR session during an inpatient rehabilitation program lasting 4 weeks (40 sessions).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

February 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2021

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2021

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

February 12, 2020

Last Update Submit

November 13, 2023

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Multidimensional fatigue score

    Change in total fatigue score measured with the MFI-20 questionnaire

    Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program

Secondary Outcomes (4)

  • 6-min walking distance

    Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program

  • Heart rate variability

    Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program

  • Visuomotor reaction time

    Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program

  • Correlation between fatigue and physical performance

    Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program

Other Outcomes (2)

  • Physical activity

    During the 4 weeks of the PR program (continuous measurement)

  • Daily subjective fatigue

    Every morning of the 4 weeks PR program

Study Arms (1)

Inpatient pulmonary rehabilitation

Multidisciplinary inpatient pulmonary rehabilitation program lasting 4 weeks (40 sessions, 2 sessions per day, 5 days per week).

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admited for an inpatient PR program at one of the three following pulmonary rehabilitation center will be consecutively recruiting: * Clinique du Souffle La Vallonie (Lodève, France) * Clinique du Souffle La Solane (Osseja, France) * Clinique du Souffle Les Clarines (Riom-es-Montagnes, France)

You may qualify if:

  • Patients admited for a 4-weeks inpatient pulmonary rehabilitation program
  • With a confirmed diagnosis of COPD

You may not qualify if:

  • Severe or unstable heart disease
  • Orthopedic, neurologic or psychatric comorbities
  • Recent exacerbation (\<4 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinique du Souffle La Vallonie

Lodève, 34700, France

Location

Clinique du Souffle La Solane

Osséja, 66340, France

Location

Clinique du Souffle Les Clarines

Riom-ès-Montagnes, 15400, France

Location

Related Publications (1)

  • Alexandre F, Molinier V, Hognon L, Charbonnel L, Calvat A, Castanyer A, Henry T, Marcenac A, Jollive M, Vernet A, Oliver N, Heraud N. Time-Course of Changes in Multidimensional Fatigue and Functional Exercise Capacity and Their Associations during a Short Inpatient Pulmonary Rehabilitation Program. COPD. 2023 Dec;20(1):55-63. doi: 10.1080/15412555.2022.2164261.

    PMID: 36655947RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nelly Heraud, PhD

    Direction de la recherche et de l'innovation Santé, GCS CIPS, Korian, France

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 21, 2020

Study Start

February 15, 2020

Primary Completion

March 13, 2021

Study Completion

April 9, 2021

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations

FR(3)