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

Primary Purpose

COPD

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Strength training
Endurance training
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de BrestRecruiting
  • CH Pays de MorlaixRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Strength

Endurance

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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."
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.
Measuring upper limb endurance
with the 6-minute Peg Board and Ring Test (6PBRT)
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.
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.
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

Full Information

First Posted
July 16, 2018
Last Updated
December 3, 2020
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT03611036
Brief Title
Effect of Different Form of Upper Limb Muscles Training on Dyspnea in COPD
Acronym
REHABSUP
Official Title
Effect of Different Form of Upper Limb Muscles Training on Dyspnea in COPD
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 21, 2018 (Actual)
Primary Completion Date
November 21, 2022 (Anticipated)
Study Completion Date
December 21, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a multicenter, prospective, randomized, open-label study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strength
Arm Type
Experimental
Arm Description
Patients will follow the pulmonary rehabilitation program associated with upper limbs strength training for a duration of 4 weeks
Arm Title
Endurance
Arm Type
Active Comparator
Arm Description
Patients will follow the pulmonary rehabilitation program associated with upper limbs endurance training for a duration of 4 weeks
Intervention Type
Other
Intervention Name(s)
Strength training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Endurance training
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Change from inclusion at 4 week
Secondary Outcome Measure Information:
Title
Compare dyspnea in daily life between the 2 groups
Description
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."
Time Frame
At inclusion and week 4
Title
Compare dyspnea in daily life between the 2 groups
Description
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.
Time Frame
At inclusion and week 4
Title
Measuring upper limb endurance
Description
with the 6-minute Peg Board and Ring Test (6PBRT)
Time Frame
At inclusion and week 4
Title
Compare dyspnea at the end of a functional test using the upper limbs
Description
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.
Time Frame
At inclusion and week 4
Title
Compare upper limbs muscle fatigue at the end of a functional test using the upper limbs
Description
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.
Time Frame
At inclusion and week 4
Title
Compare the evolution of upper limb strength between the 2 groups.
Description
Measurement of the strength of deltoids, biceps and brachial triceps, with hand held dynamometer
Time Frame
At inclusion and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc BEAUMONT, PhD
Phone
02 98 62 61 60
Ext
7750
Email
marc.beaumont@chu-brest.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marc BEAUMONT, PhD
Phone
02 98 62 61 60
Ext
7750
Email
mbeaumont@ch-morlaix.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc BEAUMONT, PhD
Organizational Affiliation
CH des pays de Morlaix
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francis COUTURAUD, MD, PhD
Organizational Affiliation
CHRU de Brest
Official's Role
Study Director
Facility Information:
Facility Name
CHRU de Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis COUTURAUD, Pr
Facility Name
CH Pays de Morlaix
City
Morlaix
ZIP/Postal Code
29672
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc BEAUMONT, PhD
Phone
+33298626160
Ext
7750
Email
mbeaumont@ch-morlaix.fr
First Name & Middle Initial & Last Name & Degree
Marc BEAUMONT, PhD
Phone
+33298626160
Ext
7750
Email
marc.beaumont@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Anne-Cécile BERRIET, PT
First Name & Middle Initial & Last Name & Degree
Loic PERAN, PT
First Name & Middle Initial & Last Name & Degree
Catherine LE BER, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32957334
Citation
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.
Results Reference
derived

Learn more about this trial

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

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