Chronic Obstructive Pulmonary Disease Clinical Trial
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
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.
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.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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