Recruiting

Pulmonary Rehab

Sponsor:

McGill University

Code:

NCT02542826

Conditions

Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Pulmonary Rehabilitation

Study Details

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study ID

NCT02542826

Start date

Aug, 2015

Status verified date

Feb, 2017

Completion date

Aug, 2018

Anticipated

Primary completion date

Apr, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pulmonary Rehabilitation

Interventions

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.

Primary outcome 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. [ Time Frame: Baseline and 7 weeks ]

Central Contacts and Locations

Central contacts

Dennis Jensen, Ph.D.

514-398-4184dennis.jensen@mcgill.ca

Locations

McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Dennis Jensen, Ph.D.

514-398-4184dennis.jensen@mcgill.ca

Principal Investigator:

Dennis Jensen, Ph.D.

More Information

Sponsor

McGill University

Last update posted

Feb 14, 2017

Last verified

Feb, 2017

Keywords

  • Pulmonary Rehabilitation
  • 3-minute constant rate shuttle walk test
  • 3-minute constant rate step test
  • Dyspnea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2017-02-14.