Sensitivity of New Exercise Tests in Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ipratropium bromide
placebo
constant rate step test
constant rate shuttle walk test
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease (COPD), Exercise, 3-min constant rate stepping test, 3-min constant rate walking test, Bronchodilation, Ipratropium bromide
Eligibility Criteria
Inclusion Criteria:
- age > 50 years
- smoking history > 10 packs/year
- post-bronchodilator FEV1 between 30 and 80% predicted and FEV1/FVC < 70% as assessed in previous pulmonary function test (GOLD stage II and III)
Exclusion Criteria:
- respiratory exacerbation within the preceding 2 months
- history of asthma
- significant O2 desaturation (SaO2 < 85%) at rest or during exercise
- presence of another pathology that could influence exercise tolerance
Sites / Locations
- Hélène Perrault
- François Maltais
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ipratropium bromide
placebo
Arm Description
acute bronchodilation: ipratropium bromide
placebo nebulization
Outcomes
Primary Outcome Measures
Dyspnea at the end of the 3-minute walking and stepping exercises
Secondary Outcome Measures
Full Information
NCT ID
NCT00807534
First Posted
December 10, 2008
Last Updated
February 7, 2011
Sponsor
Laval University
Collaborators
McGill University, Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT00807534
Brief Title
Sensitivity of New Exercise Tests in Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Measurement of Exertional Dyspnea in the Primary Care Setting in Patients With COPD, Phase 2: Sensitivity of the Step Test and Shuttle Walk to Detect Improvement in Dyspnea Following Bronchodilation in Patients With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Laval University
Collaborators
McGill University, Boehringer Ingelheim
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was designed to test the following hypothesis:
The 3-min constant rate step test and the 3-min constant rate shuttle walk test will be sensitive to detect improvement in exertional dyspnea following acute bronchodilation in patients with COPD.
Detailed Description
BACKGROUND: Cycle and/or treadmill exercise modalities may not adequately reflect the constraints of the physical activities of daily living and may not easily transfer to the primary care setting. Thus, alternatives need to be considered. The use of a continuous shuttle walk test at one or several specified constant walking paces for the assessment of exertional dyspnea has not yet been developed. Since walking is the basic movement for locomotion in everyday life, it seems appropriate to examine the use of a walking test. In addition to walking, one of the most frequent exercise constraints of everyday life lies in the fact of climbing stairs. The step testing methodology has however not specifically focused on the measurement of exertional dyspnea and has not been carried out in patients with COPD. There is a good rationale for the development of a step test for evaluation of exertional dyspnea and exercise tolerance in the primary care setting: (i) simple, inexpensive equipment that requires very little storage space, (ii) ability to externally dictate the work intensity by use of a timing device such as a metronome to regulate the stepping speed, (iii) exercise that is consistent with everyday activity known to be an important dyspnea stimulus (i.e. stair climbing, hill walking), (iv) use of large muscle groups which ensures that ventilation is increased to support the working muscles, with a resultant increase in dyspnea in patients with reduced ventilatory capacity.
GENERAL OBJECTIVE: The general purpose of this investigator-driven initiative is to develop simple exercise tests to assess the effects of pharmacological and rehabilitation interventions on exertional dyspnea in the primary care setting.
METHODS: The study will require five visits at the research centre. The first visit will include pulmonary function testing and an incremental shuttle walking test to characterize the functional capacity of the participants. Patients will also be familiarized to both exercise tests (stepping and walking). The goal of the familiarization will be to reduce the learning effect that typically occurs when an individual completes the same endurance test several times. During the following four visits, patients will complete a total of four exercise tests: two 3-min constant rate step tests and two 3-min constant rate shuttle walks. Each test will be preceded by the nebulization of either a placebo or 500 ug of ipratropium bromide (Atrovent). The placebo or medication will be administered 1 hour prior to the beginning of each test. The study will follow a crossover design, such that each patient will serve as his/her own control. The order of the endurance tests (stepping or walking) will be randomized. Finally, the medication (placebo or ipratropium) will be administered in a randomized, double-blind fashion. The exercise test will be supervised by someone who is unaware of the medication that was administered in order to maintain blinding of the study.
Data analysis: Responsiveness will be evaluated by the change in dyspnea Borg score at completion of the 3-min constant rate stepping test and the 3-min constant rate walking test between the placebo and ipratropium bromide exercises. Paired t tests will be used to evaluate the difference in end-exercise dyspnea between the ipratropium and the placebo conditions for the two forms of exercise. We will also calculate the Standardized Response Mean (SRM), e.g., the mean change in dyspnea Borg score divided by standard deviation (SD) of mean change. A SRM value of 0.5 or more suggests a large change. Bronchodilator-induced changes in E, O2, CO2, and heart rate will be compared between the 3-min constant rate stepping test and the 3-min constant rate walking test. Comparisons will be done using a repeated measure design (ANOVA). Significance level will be set at a p value of 0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Exercise, 3-min constant rate stepping test, 3-min constant rate walking test, Bronchodilation, Ipratropium bromide
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ipratropium bromide
Arm Type
Active Comparator
Arm Description
acute bronchodilation: ipratropium bromide
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo nebulization
Intervention Type
Drug
Intervention Name(s)
ipratropium bromide
Other Intervention Name(s)
Atrovent
Intervention Description
ipratropium bromide nebulization
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo nebulization
Intervention Type
Behavioral
Intervention Name(s)
constant rate step test
Other Intervention Name(s)
Atrovent
Intervention Description
nebulization of 500ug
Intervention Type
Behavioral
Intervention Name(s)
constant rate shuttle walk test
Other Intervention Name(s)
Atrovent
Intervention Description
nebulization of 500ug
Primary Outcome Measure Information:
Title
Dyspnea at the end of the 3-minute walking and stepping exercises
Time Frame
at the end of the 3-minute exercises
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 50 years
smoking history > 10 packs/year
post-bronchodilator FEV1 between 30 and 80% predicted and FEV1/FVC < 70% as assessed in previous pulmonary function test (GOLD stage II and III)
Exclusion Criteria:
respiratory exacerbation within the preceding 2 months
history of asthma
significant O2 desaturation (SaO2 < 85%) at rest or during exercise
presence of another pathology that could influence exercise tolerance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Maltais, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hélène Perrault, Ph.D.
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hélène Perrault
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
François Maltais
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
22509905
Citation
Sava F, Perrault H, Brouillard C, Darauay C, Hamilton A, Bourbeau J, Maltais F. Detecting improvements in dyspnea in COPD using a three-minute constant rate shuttle walking protocol. COPD. 2012 Aug;9(4):395-400. doi: 10.3109/15412555.2012.674164. Epub 2012 Apr 18.
Results Reference
derived
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Sensitivity of New Exercise Tests in Chronic Obstructive Pulmonary Disease (COPD)
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