Clinical trial NCT02542826: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Rehabilitation
3-minute constant rate shuttle walk test
3-minute constant rate step test
Dyspnea
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, Montreal
name: Laval University
First posted: 2015-09-07
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: Baseline and 7 weeks
Secondary outcomes:
measure: Change (post- minus pre- pulmonary rehab) in dyspnea intensity ratings on the Borg 0-10 ratio category scale
timeFrame: Baseline and 7 weeks
Other outcomes:
measure: Change (post- minus pre- pulmonary rehab) in spirometry (FEV1, FVC, and FEV1/FVC)
timeFrame: Baseline and 7 weeks
measure: Change (post- minus pre- pulmonary rehab) in lung volumes (TLC, FRC, RV)
timeFrame: Baseline and 7 weeks
measure: Change (post- minus pre- pulmonary rehab) in airways resistance (Raw, sRaw)
timeFrame: Baseline and 7 weeks
measure: Change (post- minus pre- pulmonary rehab) CCQ
timeFrame: Baseline and 7 weeks
measure: Change (post- minus pre- pulmonary rehab) CRQ
timeFrame: Baseline and 7 weeks
measure: Change (post- minus pre- pulmonary rehab) IPAQ
timeFrame: Baseline and 7 weeks
measure: Change (post- minus pre- pulmonary rehab) BDI/TDI
timeFrame: Baseline and 7 weeks
measure: Change (post- minus pre- pulmonary rehab) CAT
timeFrame: Baseline and 7 weeks
measure: 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
timeFrame: Baseline and 7 weeks
measure: 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
timeFrame: Baseline and 7 weeks
measure: 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
timeFrame: Baseline and 7 weeks
measure: Change (post- minus pre- pulmonary rehab) in the 6-minute walk distance
timeFrame: Baseline and 7 weeks
measure: Change (post- minus pre- pulmonary rehab) in body composition assessed by dual-energy X-ray absorptiometry
timeFrame: Baseline and 7 weeks
measure: Change (post- minus pre- pulmonary rehab) in isometric quadriceps peak torque
timeFrame: Baseline and 7 weeks
Locations:
city: Montreal
country: Canada
facility: McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University
name: Dennis Jensen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: