Pulmonary Rehab, Dyspnea, Walk and Step Testing in COPD

Not Applicable

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Other: Pulmonary Rehabilitation

• Registration Number: NCT02542826
• Lead Sponsor: McGill University

Brief Summary

This is a multi-site collaborative study that will be done in the context of three Quebec hospitals' outpatient pulmonary rehabilitation programs: Montreal Chest Institute; University of Laval, and Hopital Sacre-Coeur Montreal. The objectives are two-fold. First, to determine the Minimal Clinical Important Difference in intensity ratings of perceived breathlessness for each of the 3-min constant rate shuttle walking (3-MWT) and stair stepping (3-MST) protocols in patients with chronic obstructive pulmonary disease (COPD). Second, to test the hypothesis that both the 3-MWT and 3-MST protocols are able to detect statistically significant and clinically-meaningful improvements in exertional breathlessness following an 7-12 week outpatient rehabilitative exercise training program in COPD.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-10
• Last Update Posted: 2017-02-14
• Primary Completion: 2018-04
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Male or Female
• Ambulatory
• Moderate-to-very severe COPD (GOLD Stage 2-4)

Exclusion Criteria

• Respiratory exacerbation in the previous 6 weeks
• Change in medication dosage/frequency in the previous 6 weeks
• Clinical evidence of asthma
• Cardiovascular and/or neuromuscular diseases that are unstable and/or that may contribute to exercise limitation
• Any other contraindications to exercise training/testing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulmonary Rehabilitation	Pulmonary Rehabilitation	-

Primary Outcome Measures

Name	Time	Method
Minimal clinically important difference (MCID) with regards to the change in breathlessness intensity ratings at the end of each of the 3-MST and 3-MWT.	Baseline and 7 weeks

Secondary Outcome Measures

Name	Time	Method
Change (post- minus pre- pulmonary rehab) in dyspnea intensity ratings on the Borg 0-10 ratio category scale	Baseline and 7 weeks	Borg 0-10 category ratio scale

Trial Locations

Locations (1)

McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada