Sensitivity of New Exercise Tests in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Collaborators:
McGill University
Boehringer Ingelheim
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00807534
First received: December 10, 2008
Last updated: February 7, 2011
Last verified: May 2010
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Drug: ipratropium bromide
Drug: placebo
Behavioral: constant rate step test
Behavioral: constant rate shuttle walk test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Dyspnea at the end of the 3-minute walking and stepping exercises [ Time Frame: at the end of the 3-minute exercises ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: October 2008
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ipratropium bromide
acute bronchodilation: ipratropium bromide
Drug: ipratropium bromide
ipratropium bromide nebulization
Other Name: Atrovent
Behavioral: constant rate step test
nebulization of 500ug
Other Name: Atrovent
Behavioral: constant rate shuttle walk test
nebulization of 500ug
Other Name: Atrovent
Placebo Comparator: placebo
placebo nebulization
Drug: placebo
placebo nebulization
Behavioral: constant rate step test
nebulization of 500ug
Other Name: Atrovent
Behavioral: constant rate shuttle walk test
nebulization of 500ug
Other Name: Atrovent

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807534

Locations
Canada, Quebec
Hélène Perrault
Montreal, Quebec, Canada
François Maltais
Quebec City, Quebec, Canada, G1V4G5
Sponsors and Collaborators
Laval University
McGill University
Boehringer Ingelheim
Investigators
Principal Investigator: François Maltais, MD Laval University
Principal Investigator: Hélène Perrault, Ph.D. McGill University
  More Information

No publications provided by Laval University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: François Maltais, Laval University
ClinicalTrials.gov Identifier: NCT00807534     History of Changes
Other Study ID Numbers: BI 244.2513
Study First Received: December 10, 2008
Last Updated: February 7, 2011
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
Chronic Obstructive Pulmonary Disease (COPD)
Exercise
3-min constant rate stepping test
3-min constant rate walking test
Bronchodilation
Ipratropium bromide

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Ipratropium
Anti-Asthmatic Agents
Anticonvulsants
Autonomic Agents
Bronchodilator Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014