NCT04279730|Completed
Fatigue and Physical Performance During Pulmonary Rehabilitation
PROMOD
Impact of Fatigue on Physical Performance During a Pulmonary Rehabilitation Program in Patients With COPD
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PROMOD
Impact of Fatigue on Physical Performance During a Pulmonary Rehabilitation Program in Patients With COPD
Sponsor study identifier
observational
96
1 country
3
Study Start
February 15, 2020
Actual (reported)Primary Completion
March 13, 2021
Actual (reported)Study Completion
April 9, 2021
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 9, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 12, 2020
Actual (reported)February 15, 2020
Actual (reported)February 21, 2020
Actual (reported)March 13, 2021
Actual (reported)April 9, 2021
Actual (reported)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
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
Physical activity
During the 4 weeks of the PR program (continuous measurement)
Daily subjective fatigue
Every morning of the 4 weeks PR program
Multidisciplinary inpatient pulmonary rehabilitation program lasting 4 weeks (40 sessions, 2 sessions per day, 5 days per week).
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)
Clinique du Souffle La Vallonie
Lodève, 34700, France
Clinique du Souffle La Solane
Osséja, 66340, France
Clinique du Souffle Les Clarines
Riom-ès-Montagnes, 15400, France
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.
Nelly Heraud, PhD
Direction de la recherche et de l'innovation Santé, GCS CIPS, Korian, France
96 participants (actual enrollment reported by the registry).
First Submitted
February 12, 2020
First Posted
February 21, 2020
Study Start
February 15, 2020
Actual (reported)Educational Follow-up in COPD Patients After Pulmonary Rehabilitation.
Contact the study team to confirm eligibility.
Primary Completion
March 13, 2021
Actual (reported)Study Completion
April 9, 2021
Actual (reported)Last Updated
November 14, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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