Pulmonary Rehab, Dyspnea, Walk and Step Testing in COPD

Constant Rate Shuttle Walking and Stair Stepping Tests to Assess Exertional Dyspnea in COPD: Responsiveness to Pulmonary Rehabilitation and Minimal Clinically Important Difference

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Pulmonary Rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre
      • Contact: Dennis Jensen, Ph.D.; Phone Number: 0541 514-398-4184; Email: dennis.jensen@mcgill.ca
      • Principal Investigator: Dennis Jensen, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pulmonary Rehabilitation

Other: Pulmonary Rehabilitation; Patients will participate in 3 exercise training sessions/wk for a period of 7-12 wks at one of 4 sites in Quebec. Each training session will include 30-45 min of aerobic training (cycling and/or treadmill walking) at a target intensity of 80% of the maximal heart rate achieved during a symptom-limited incremental cycle exercise test performed prior to the pulmonary rehabilitation program; and 20-30 min of strength training exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change (post- minus pre- pulmonary rehab) in spirometry (FEV1, FVC, and FEV1/FVC)	expressed in L and as % predicted	Baseline and 7 weeks
Change (post- minus pre- pulmonary rehab) in lung volumes (TLC, FRC, RV)	expressed in L and as % predicted	Baseline and 7 weeks
Change (post- minus pre- pulmonary rehab) in airways resistance (Raw, sRaw)	expressed in L and as % predicted	Baseline and 7 weeks
Change (post- minus pre- pulmonary rehab) CCQ	questionnaire	Baseline and 7 weeks
Change (post- minus pre- pulmonary rehab) CRQ	questionnaire	Baseline and 7 weeks
Change (post- minus pre- pulmonary rehab) IPAQ	questionnaire	Baseline and 7 weeks
Change (post- minus pre- pulmonary rehab) BDI/TDI	questionnaire	Baseline and 7 weeks
Change (post- minus pre- pulmonary rehab) CAT	questionnaire	Baseline and 7 weeks
Change (post- minus pre- pulmonary rehab) in Exercise Endurance Time (EET) to constant power output cycling exercise performed at 75% of the peak incremental cycling power output achieved prior to start of pulmonary rehab	EET, in minutes and sec	Baseline and 7 weeks
Change (post- minus pre- pulmonary rehab) in peak VO2 to constant power output cycling exercise performed at 75% of the peak incremental cycling power output achieved prior to start of pulmonary rehab	in ml/kg/min and as %predicted	Baseline and 7 weeks
Change (post- minus pre- pulmonary rehab) in peak Ventilation to constant power output cycling exercise performed at 75% of the peak incremental cycling power output achieved prior to start of pulmonary rehab	in L/min, as %predicted and as % of MVV (=FEV1x35)	Baseline and 7 weeks
Change (post- minus pre- pulmonary rehab) in the 6-minute walk distance	in m	Baseline and 7 weeks
Change (post- minus pre- pulmonary rehab) in body composition assessed by dual-energy X-ray absorptiometry	Lean body mass (g)	Baseline and 7 weeks
Change (post- minus pre- pulmonary rehab) in isometric quadriceps peak torque	% predicted	Baseline and 7 weeks

Collaborators and Investigators

• Sponsor: McGill University
• Collaborators: Laval University; Mount Sinai Hospital, Montreal

Publications and helpful links

Helpful Links

• Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of McGill University

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: August 25, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 10, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Pulmonary Rehabilitation; Dyspnea; 3-minute constant rate shuttle walk test; 3-minute constant rate step test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
• Other Study ID Numbers: MP-CUSM-15-074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No