Pulmonary Rehab, Dyspnea, Walk and Step Testing in COPD
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Rehabilitation, 3-minute constant rate shuttle walk test, 3-minute constant rate step test, Dyspnea
Eligibility Criteria
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
Sites / Locations
- McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulmonary Rehabilitation
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change (post- minus pre- pulmonary rehab) in dyspnea intensity ratings on the Borg 0-10 ratio category scale
Borg 0-10 category ratio scale
Full Information
NCT ID
NCT02542826
First Posted
August 25, 2015
Last Updated
February 10, 2017
Sponsor
McGill University
Collaborators
Mount Sinai Hospital, Montreal, Laval University
1. Study Identification
Unique Protocol Identification Number
NCT02542826
Brief Title
Pulmonary Rehab, Dyspnea, Walk and Step Testing in COPD
Official Title
Constant Rate Shuttle Walking and Stair Stepping Tests to Assess Exertional Dyspnea in COPD: Responsiveness to Pulmonary Rehabilitation and Minimal Clinically Important Difference
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
Collaborators
Mount Sinai Hospital, Montreal, Laval University
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary Rehabilitation, 3-minute constant rate shuttle walk test, 3-minute constant rate step test, Dyspnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Rehabilitation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
Baseline and 7 weeks
Secondary Outcome Measure Information:
Title
Change (post- minus pre- pulmonary rehab) in dyspnea intensity ratings on the Borg 0-10 ratio category scale
Description
Borg 0-10 category ratio scale
Time Frame
Baseline and 7 weeks
Other Pre-specified Outcome Measures:
Title
Change (post- minus pre- pulmonary rehab) in spirometry (FEV1, FVC, and FEV1/FVC)
Description
expressed in L and as % predicted
Time Frame
Baseline and 7 weeks
Title
Change (post- minus pre- pulmonary rehab) in lung volumes (TLC, FRC, RV)
Description
expressed in L and as % predicted
Time Frame
Baseline and 7 weeks
Title
Change (post- minus pre- pulmonary rehab) in airways resistance (Raw, sRaw)
Description
expressed in L and as % predicted
Time Frame
Baseline and 7 weeks
Title
Change (post- minus pre- pulmonary rehab) CCQ
Description
questionnaire
Time Frame
Baseline and 7 weeks
Title
Change (post- minus pre- pulmonary rehab) CRQ
Description
questionnaire
Time Frame
Baseline and 7 weeks
Title
Change (post- minus pre- pulmonary rehab) IPAQ
Description
questionnaire
Time Frame
Baseline and 7 weeks
Title
Change (post- minus pre- pulmonary rehab) BDI/TDI
Description
questionnaire
Time Frame
Baseline and 7 weeks
Title
Change (post- minus pre- pulmonary rehab) CAT
Description
questionnaire
Time Frame
Baseline and 7 weeks
Title
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
Description
EET, in minutes and sec
Time Frame
Baseline and 7 weeks
Title
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
Description
in ml/kg/min and as %predicted
Time Frame
Baseline and 7 weeks
Title
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
Description
in L/min, as %predicted and as % of MVV (=FEV1x35)
Time Frame
Baseline and 7 weeks
Title
Change (post- minus pre- pulmonary rehab) in the 6-minute walk distance
Description
in m
Time Frame
Baseline and 7 weeks
Title
Change (post- minus pre- pulmonary rehab) in body composition assessed by dual-energy X-ray absorptiometry
Description
Lean body mass (g)
Time Frame
Baseline and 7 weeks
Title
Change (post- minus pre- pulmonary rehab) in isometric quadriceps peak torque
Description
% predicted
Time Frame
Baseline and 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis Jensen, Ph.D.
Phone
514-398-4184
Ext
0541
Email
dennis.jensen@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Jensen, Ph.D.
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Jensen, Ph.D.
Phone
514-398-4184
Ext
0541
Email
dennis.jensen@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Dennis Jensen, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.mcgill.ca/cerpl/
Description
Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of McGill University
Learn more about this trial
Pulmonary Rehab, Dyspnea, Walk and Step Testing in COPD
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