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Pulmonary Rehab, Dyspnea, Walk and Step Testing in COPD

Constant Rate Shuttle Walking and Stair Stepping Tests to Assess Exertional Dyspnea in COPD: Responsiveness to Pulmonary Rehabilitation and Minimal Clinically Important Difference

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02542826
Enrollment
80
Registered
2015-09-07
Start date
2015-08-31
Completion date
2018-08-31
Last updated
2017-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

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

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.

Interventions

OTHERPulmonary 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.

Sponsors

Mount Sinai Hospital, Montreal
CollaboratorOTHER
Laval University
CollaboratorOTHER
McGill University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frameDescription
Change (post- minus pre- pulmonary rehab) in dyspnea intensity ratings on the Borg 0-10 ratio category scaleBaseline and 7 weeksBorg 0-10 category ratio scale

Other

MeasureTime frameDescription
Change (post- minus pre- pulmonary rehab) in lung volumes (TLC, FRC, RV)Baseline and 7 weeksexpressed in L and as % predicted
Change (post- minus pre- pulmonary rehab) in airways resistance (Raw, sRaw)Baseline and 7 weeksexpressed in L and as % predicted
Change (post- minus pre- pulmonary rehab) CCQBaseline and 7 weeksquestionnaire
Change (post- minus pre- pulmonary rehab) CRQBaseline and 7 weeksquestionnaire
Change (post- minus pre- pulmonary rehab) IPAQBaseline and 7 weeksquestionnaire
Change (post- minus pre- pulmonary rehab) BDI/TDIBaseline and 7 weeksquestionnaire
Change (post- minus pre- pulmonary rehab) CATBaseline and 7 weeksquestionnaire
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 rehabBaseline and 7 weeksEET, in minutes and sec
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 rehabBaseline and 7 weeksin ml/kg/min and as %predicted
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 rehabBaseline and 7 weeksin L/min, as %predicted and as % of MVV (=FEV1x35)
Change (post- minus pre- pulmonary rehab) in the 6-minute walk distanceBaseline and 7 weeksin m
Change (post- minus pre- pulmonary rehab) in body composition assessed by dual-energy X-ray absorptiometryBaseline and 7 weeksLean body mass (g)
Change (post- minus pre- pulmonary rehab) in isometric quadriceps peak torqueBaseline and 7 weeks% predicted
Change (post- minus pre- pulmonary rehab) in spirometry (FEV1, FVC, and FEV1/FVC)Baseline and 7 weeksexpressed in L and as % predicted

Countries

Canada

Contacts

Primary ContactDennis Jensen, Ph.D.
dennis.jensen@mcgill.ca514-398-4184

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026