Pulmonary Rehab, Dyspnea, Walk and Step Testing in COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02542826
• Other study ID #: MP-CUSM-15-074
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2015
• Last updated: February 10, 2017
• Start date: August 2015
• Est. completion date: August 2018

Study information

• Verified date: February 2017
• Source: McGill University
• Contact: Dennis Jensen, Ph.D.
• Phone: 514-398-4184
• Email: dennis.jensen[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Dyspnea
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Canada	McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University	Laval University, Mount Sinai Hospital, Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change (post- minus pre- pulmonary rehab) in spirometry (FEV1, FVC, and FEV1/FVC)	expressed in L and as % predicted	Baseline and 7 weeks
Other	Change (post- minus pre- pulmonary rehab) in lung volumes (TLC, FRC, RV)	expressed in L and as % predicted	Baseline and 7 weeks
Other	Change (post- minus pre- pulmonary rehab) in airways resistance (Raw, sRaw)	expressed in L and as % predicted	Baseline and 7 weeks
Other	Change (post- minus pre- pulmonary rehab) CCQ	questionnaire	Baseline and 7 weeks
Other	Change (post- minus pre- pulmonary rehab) CRQ	questionnaire	Baseline and 7 weeks
Other	Change (post- minus pre- pulmonary rehab) IPAQ	questionnaire	Baseline and 7 weeks
Other	Change (post- minus pre- pulmonary rehab) BDI/TDI	questionnaire	Baseline and 7 weeks
Other	Change (post- minus pre- pulmonary rehab) CAT	questionnaire	Baseline and 7 weeks
Other	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
Other	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
Other	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
Other	Change (post- minus pre- pulmonary rehab) in the 6-minute walk distance	in m	Baseline and 7 weeks
Other	Change (post- minus pre- pulmonary rehab) in body composition assessed by dual-energy X-ray absorptiometry	Lean body mass (g)	Baseline and 7 weeks
Other	Change (post- minus pre- pulmonary rehab) in isometric quadriceps peak torque	% predicted	Baseline and 7 weeks
Primary	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	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

External Links

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