Pulmonary Rehab, Dyspnea, Walk and Step Testing in COPD

NCT ID: NCT02542826

Last Updated: 2017-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pulmonary Rehabilitation

Group Type EXPERIMENTAL

Pulmonary Rehabilitation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mount Sinai Hospital, Montreal

OTHER

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role collaborator

McGill University

OTHER

Sponsor Role lead

Responsible Party

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Dennis Jensen, Ph.D.

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dennis Jensen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

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

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Dennis Jensen, Ph.D.

Role: CONTACT

514-398-4184 ext. 0541

Facility Contacts

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Dennis Jensen, Ph.D.

Role: primary

514-398-4184 ext. 0541

Related Links

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http://www.mcgill.ca/cerpl/

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

Other Identifiers

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MP-CUSM-15-074

Identifier Type: -

Identifier Source: org_study_id

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