NCT03611036

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 21, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2023

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

4.2 years

First QC Date

July 16, 2018

Last Update Submit

January 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Compare dyspnea in daily life between the 2 groups

    At inclusion and week 4

  • Compare dyspnea in daily life between the 2 groups

    At inclusion and week 4

  • Measuring upper limb endurance

    At inclusion and week 4

  • Compare dyspnea at the end of a functional test using the upper limbs

    At inclusion and week 4

  • Compare upper limbs muscle fatigue at the end of a functional test using the upper limbs

    At inclusion and week 4

  • +1 more secondary outcomes

Study Arms (2)

Strength

EXPERIMENTAL

Patients will follow the pulmonary rehabilitation program associated with upper limbs strength training for a duration of 4 weeks

Other: Strength training

Endurance

ACTIVE COMPARATOR

Patients will follow the pulmonary rehabilitation program associated with upper limbs endurance training for a duration of 4 weeks

Other: Endurance training

Interventions

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

Strength

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

Endurance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Brest

Brest, France

Location

CH Pays de Morlaix

Morlaix, 29672, France

Location

Related Publications (2)

  • Beaumont M, Peran L, Berriet AC, Ber CL, Courtois-Communier E, Couturaud F. Effect of different forms of upper limb muscle training on dyspnea in chronic obstructive pulmonary disease: a randomised controlled trial. Ann Phys Rehabil Med. 2025 Oct;68(7):102021. doi: 10.1016/j.rehab.2025.102021. Epub 2025 Sep 17.

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Resistance TrainingEndurance Training

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marc BEAUMONT, PhD

    CH des pays de Morlaix

    PRINCIPAL INVESTIGATOR
  • Francis COUTURAUD, MD, PhD

    CHRU de Brest

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a multicenter, prospective, randomized, open-label study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2018

First Posted

August 2, 2018

Study Start

November 21, 2018

Primary Completion

February 6, 2023

Study Completion

February 6, 2023

Last Updated

January 24, 2025

Record last verified: 2025-01

Locations