Fatigue and Physical Performance During Pulmonary Rehabilitation

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT04279730
• Lead Sponsor: 5 Santé

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).

Study Timeline

• Study First Submitted: 2020-02-12
• Study Start: 2020-02-15
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-21
• Primary Completion: 2021-03-13
• Study Completion: 2021-04-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multidimensional fatigue score	Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program	Change in total fatigue score measured with the MFI-20 questionnaire

Secondary Outcome Measures

Name	Time	Method
6-min walking distance	Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program	Change in walking distance during a 6-min period over a corridor of 30m length
Heart rate variability	Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program	Change in SDNN and RMSSD indices of RR intervals during a 5-min resting period and at exercise during a 6-min walking test
Visuomotor reaction time	Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program	Change in the mean of 15 reaction time in response to visual stimuli
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	Change in the strength of the correlation between indicators of fatigue (muldimensional score, heart rate variability, visuomotor reaction time) and 6-min walking distance

Trial Locations

Locations (3)

Clinique du Souffle Les Clarines; 🇫🇷 Riom-es-Montagnes, France

Clinique du Souffle La Solane; 🇫🇷 Osséja, France

Clinique du Souffle La Vallonie; 🇫🇷 Lodeve, France