An observational study in Chronic Obstructive Pulmonary Disease, sponsored by 5 Santé. Completed at 3 sites in France. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-14.
Sponsored by 5 Santé · Observational
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).
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).
2,591 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 96 is below the median of 150 across 638 observational studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →5 Santé is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Patients admited for an inpatient PR program at one of the three following pulmonary rehabilitation center will be consecutively recruiting:
Exclusion Criteria:
Multidisciplinary inpatient pulmonary rehabilitation program lasting 4 weeks (40 sessions, 2 sessions per day, 5 days per week).
Multidimensional fatigue score
Change in total fatigue score measured with the MFI-20 questionnaire
Time frame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
6-min walking distance
Change in walking distance during a 6-min period over a corridor of 30m length
Time frame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Heart rate variability
Change in SDNN and RMSSD indices of RR intervals during a 5-min resting period and at exercise during a 6-min walking test
Time frame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Visuomotor reaction time
Change in the mean of 15 reaction time in response to visual stimuli
Time frame: 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
Change in the strength of the correlation between indicators of fatigue (muldimensional score, heart rate variability, visuomotor reaction time) and 6-min walking distance
Time frame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Physical activity
Measurement of physical activity via a triaxial accelerometer
Time frame: During the 4 weeks of the PR program (continuous measurement)
Daily subjective fatigue
Fatigue evaluated by the patient every morning with a visual analogic scale
Time frame: Every morning of the 4 weeks PR program
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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