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

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ClinicalTrials.gov Identifier: NCT03611036
Recruitment Status : Not yet recruiting
First Posted : August 2, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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.

Condition or disease Intervention/treatment Phase
COPD Other: Strength training Other: Endurance training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multicenter, prospective, randomized, open-label study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Different Form of Upper Limb Muscles Training on Dyspnea in COPD
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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. [ Time Frame: Change from inclusion at 4 week ]

    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 :
  1. Compare dyspnea in daily life between the 2 groups [ Time Frame: At inclusion and week 4 ]
    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."

  2. Compare dyspnea in daily life between the 2 groups [ Time Frame: At inclusion and week 4 ]
    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.

  3. Measuring upper limb endurance [ Time Frame: At inclusion and week 4 ]
    with the 6-minute Peg Board and Ring Test (6PBRT)

  4. Compare dyspnea at the end of a functional test using the upper limbs [ Time Frame: At inclusion and week 4 ]
    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.

  5. Compare upper limbs muscle fatigue at the end of a functional test using the upper limbs [ Time Frame: At inclusion and week 4 ]
    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.

  6. Compare the evolution of upper limb strength between the 2 groups. [ Time Frame: At inclusion and week 4 ]
    Measurement of the strength of deltoids, biceps and brachial triceps, with hand held dynamometer



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611036


Contacts
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Contact: Marc BEAUMONT 02 98 62 61 60 poste 7750 marc.beaumont@univ-brest.fr

Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Marc BEAUMONT CH Morlaix
Principal Investigator: Francis COUTURAUD CHRU de Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03611036     History of Changes
Other Study ID Numbers: REHABSUP (29BRC18.0070)
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms