Effect of Different Form of Upper Limb Muscles Training on Dyspnea in COPD (REHABSUP)

Evaluate the effect of upper limbs strength training versus the effect of upper limbs endurance training, on dyspnea, in patients with COPD during a pulmonary rehabilitation program.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Strength training; Other: Endurance training

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France
    • CHRU de Brest
  • Morlaix, France, 29672
    • CH Pays de Morlaix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient with stage 2 to 4 (A to D) COPD admitted to a pulmonary rehabilitation program (4 weeks)
• Patient aged 18 or over
• Patient able to consent and having signed a consent form

Exclusion Criteria:

• Patient with pain, osteoarthritis or shoulder surgery
• Patient with a history of Pneumonectomy, lobectomy less than 6 months old
• Refusal of participation
• Patient with an inability to complete a pulmonary rehabilitation program in totality
• Pregnant or breast-feeding women
• Patient under tutorship or curatorship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strength; Patients will follow the pulmonary rehabilitation program associated with upper limbs strength training for a duration of 4 weeks	Other: Strength training; Upper limbs Strength training; done with dumbbells whose weight corresponds to 60-80% of the maximal voluntary force in abduction measured initially, during 4 weeks
Active Comparator: Endurance; Patients will follow the pulmonary rehabilitation program associated with upper limbs endurance training for a duration of 4 weeks	Other: Endurance training; Upper limbs Endurance training of the ; done with dumbbells whose weight corresponds to 30% of the maximum voluntary force in abduction measured initially, during 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the effect of upper limbs strength training versus the effect of upper limb endurance training on dyspnea in patients with COPD during a pulmonary rehabilitation program.	Measurement of dyspnea using the London Chest Daily Activity Living (LCADL) questionnaire. This 15-item, self-administered questionnaire allows an evaluation of dyspnea in patients with COPD during daily activities divided into four components: self-care, domestic, physical, and leisure. Patients could score from 0: "I would not do anyway" to 5: "I need someone else to do this". LCADL score is calculated by aggregating the points assigned to each question, with a higher score representing maximal disability.	Change from inclusion at 4 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare dyspnea in daily life between the 2 groups	Measurement of dyspnea using mMRC scale. mMRC dyspnea scale is the first self-administered scale which assesses the impact of dyspnea on ADL. It consists of five grades increasing in severity of chronic respiratory disease from 0 : "I only get breathless with strenuous exercise" to 4 : "I am too breathless to leave the house or I am breathless when dressing or undressing."	At inclusion and week 4
Compare dyspnea in daily life between the 2 groups	Measurement of dyspnea using Dyspnea-12 questionnaire. This 12-item self-administered questionnaire measures dyspnea severity in both its physical and affective components, independently from activity limitation. Patients score ranges from "none" (corresponding to score 0) to "severe" (score 3). Dyspnea-12 score is calculated by aggregating the points assigned to each question; the higher the score, the greater the severity.	At inclusion and week 4
Measuring upper limb endurance	with the 6-minute Peg Board and Ring Test (6PBRT)	At inclusion and week 4
Compare dyspnea at the end of a functional test using the upper limbs	Measurement of dyspnea with Borg scale at the end of 6PBRT. The measure is a rating on a scale from 0 to 10 attached to different words of appreciation: "very light, difficult, painful ..." effort.	At inclusion and week 4
Compare upper limbs muscle fatigue at the end of a functional test using the upper limbs	Measurement of upper limbs muscle fatigue with Borg scale at the end of 6PBRT. The measure is a rating on a scale from 0 to 10 attached to different words of appreciation: "very light, difficult, painful ..." effort.	At inclusion and week 4
Compare the evolution of upper limb strength between the 2 groups.	Measurement of the strength of deltoids, biceps and brachial triceps, with hand held dynamometer	At inclusion and week 4

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Marc BEAUMONT, PhD, CH des Pays de Morlaix; Study Director: Francis COUTURAUD, MD, PhD, CHRU de Brest

Publications and helpful links

General Publications

• Beaumont M, Peran L, Berriet AC, Le Ber C, Le Mevel P, Courtois-Communier E, Couturaud F. Effect of different form of upper limb muscles training on dyspnea in chronic obstructive pulmonary disease: A study protocol. Medicine (Baltimore). 2020 Sep 18;99(38):e22131. doi: 10.1097/MD.0000000000022131.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2018
• Primary Completion (Actual): February 6, 2023
• Study Completion (Actual): February 6, 2023

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: REHABSUP (29BRC18.0070)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No