Fatigue and Physical Performance During Pulmonary Rehabilitation

Chronic Obstructive Pulmonary Disease Clinical Trial

— PROMOD  

Official title:

Impact of Fatigue on Physical Performance During a Pulmonary Rehabilitation Program in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04279730
• Other study ID #: 5S_PROMOD
• Status: Completed
• Start date: February 15, 2020
• Est. completion date: April 9, 2021

Study information

• Verified date: November 2023
• Source: 5 Santé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 9, 2021
• Est. primary completion date: March 13, 2021
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
France	Clinique du Souffle La Vallonie	Lodeve
France	Clinique du Souffle La Solane	Osséja
France	Clinique du Souffle Les Clarines	Riom-es-Montagnes

Sponsors (2)

Lead Sponsor	Collaborator
5 Santé	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity	Measurement of physical activity via a triaxial accelerometer	During the 4 weeks of the PR program (continuous measurement)
Other	Daily subjective fatigue	Fatigue evaluated by the patient every morning with a visual analogic scale	Every morning of the 4 weeks PR program
Primary	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	6-min walking distance	Change in walking distance during a 6-min period over a corridor of 30m length	Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Secondary	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	Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Secondary	Visuomotor reaction time	Change in the mean of 15 reaction time in response to visual stimuli	Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Secondary	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	Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program