Fatigue and Physical Performance During Pulmonary Rehabilitation

NCT ID: NCT04279730

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 96 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-15
• Study Completion Date: 2021-04-09

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).

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Inpatient pulmonary rehabilitation

Multidisciplinary inpatient pulmonary rehabilitation program lasting 4 weeks (40 sessions, 2 sessions per day, 5 days per week).

No interventions assigned to this group

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

5 Santé

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nelly Heraud, PhD

Role: STUDY_DIRECTOR

Direction de la recherche et de l'innovation Santé, GCS CIPS, Korian, France

Locations

Clinique du Souffle La Vallonie

Lodève, , France

Clinique du Souffle La Solane

Osséja, , France

Clinique du Souffle Les Clarines

Riom-ès-Montagnes, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 36655947 (View on PubMed)

Other Identifiers

5S_PROMOD

Identifier Type: -

Identifier Source: org_study_id