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

COPD Clinical Trial

— REHABSUP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03611036
• Other study ID #: REHABSUP (29BRC18.0070)
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2018
• Est. completion date: December 21, 2022

Study information

• Verified date: December 2020
• Source: University Hospital, Brest
• Contact: Marc BEAUMONT, PhD
• Phone: 02 98 62 61 60
• Email: marc.beaumont[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: December 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Dyspnea

Intervention

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
• 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

Locations

Country	Name	City	State
France	CHRU de Brest	Brest
France	CH Pays de Morlaix	Morlaix

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Measuring upper limb endurance	with the 6-minute Peg Board and Ring Test (6PBRT)	At inclusion and week 4
Secondary	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
Secondary	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
Secondary	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