NCT02542826

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

2.7 years

First QC Date

August 25, 2015

Last Update Submit

February 10, 2017

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Rehabilitation3-minute constant rate shuttle walk test3-minute constant rate step testDyspnea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change (post- minus pre- pulmonary rehab) in dyspnea intensity ratings on the Borg 0-10 ratio category scale

    Baseline and 7 weeks

Other Outcomes (14)

  • Change (post- minus pre- pulmonary rehab) in spirometry (FEV1, FVC, and FEV1/FVC)

    Baseline and 7 weeks

  • Change (post- minus pre- pulmonary rehab) in lung volumes (TLC, FRC, RV)

    Baseline and 7 weeks

  • Change (post- minus pre- pulmonary rehab) in airways resistance (Raw, sRaw)

    Baseline and 7 weeks

  • +11 more other outcomes

Study Arms (1)

Pulmonary Rehabilitation

EXPERIMENTAL
Other: Pulmonary Rehabilitation

Interventions

Pulmonary RehabilitationOTHER

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.

Pulmonary Rehabilitation

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female
  • Ambulatory
  • Moderate-to-very severe COPD (GOLD Stage 2-4)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Dennis Jensen, Ph.D.

    McGill University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Jensen, Ph.D.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 25, 2015

First Posted

September 7, 2015

Study Start

August 1, 2015

Primary Completion

April 1, 2018

Study Completion

August 1, 2018

Last Updated

February 14, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)