Clinical trial NCT04279730: Fatigue and Physical Performance During Pulmonary Rehabilitation
Official title: Impact of Fatigue on Physical Performance During a Pulmonary Rehabilitation Program in Patients With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: 5 Santé
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2020-02-21
Enrollment: 96
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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)

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).

Detailed description: Exercise tolerance is an important predictor of health status in patients with chronic obstructive pulmonary disease (COPD). A reduced 6-min walking distance is associated with an increased mortality risk in these patients. Pulmonary rehabilitation (PR) is one of the most efficient strategy to counterac this effect. Patients improving their exercise tolerance after a PR program have a reduced mortality risk. However, exercise tolerance improvement is not systematic after PR, since up to 1/3 of patients do not respond to the intervention. In addition, PR's effects are limited, with a ceiling effect of performance observed in 80% of patients from 20 sessions.

Fatigue could be one candidate to explain the ceiling effect of physical performance during PR. From a theoritical point of view, national and international guidelines on PR have continuously broadened PR interventions for the last 20 years, by progressively introducing in addition to endurance training, resistance training of the lower and then the upper limbs, electrical stimulation, stretching, respiratory muscle training... From a practical point of view, several patients complain of fatigue during PR. 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. Mutdimensional questionnaires and complementary indicators such as heart rate variability or visuomotor reaction time could be introduced.

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Multidimensional fatigue score
timeFrame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Secondary outcomes:
measure: 6-min walking distance
timeFrame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
measure: Heart rate variability
timeFrame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
measure: Visuomotor reaction time
timeFrame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
measure: Correlation between fatigue and physical performance
timeFrame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Other outcomes:
measure: Physical activity
timeFrame: During the 4 weeks of the PR program (continuous measurement)
measure: Daily subjective fatigue
timeFrame: Every morning of the 4 weeks PR program
Locations:
city: Lodeve
country: France
facility: Clinique du Souffle La Vallonie
city: Osséja
country: France
facility: Clinique du Souffle La Solane
city: Riom-es-Montagnes
country: France
facility: Clinique du Souffle Les Clarines
Study officials:
affiliation: Direction de la recherche et de l'innovation Santé, GCS CIPS, Korian, France
name: Nelly Heraud, PhD
role: STUDY_DIRECTOR
References:
citation: 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.