Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD (ARFEET)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Arformoterol tartrate
Placebo: Normal Saline
Treadmill Exercise
Cycle Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring exercise;, treadmill;, cycle ergometer;, breathlessness;, leg discomfort
Eligibility Criteria
Inclusion Criteria:
- male or female patient 50 years of age or older; diagnosis of COPD; current or ex-smoker with at least 10 pack-years of smoking; a patient-reported score for breathlessness during activities of daily living of < 9 on the self-administered computerized baseline dyspnea index; a post-bronchodilator FEV1 < 80% predicted; a post-bronchodilator FEV1/FVC ratio < 70%; and clinically stable condition.
Exclusion Criteria:
- any concomitant disease that interferes with study procedures or evaluation; inability to exercise on the treadmill or cycle ergometer; inability to withhold short-acting bronchodilators for 4 hours or long-acting bronchodilators for 12 hrs (salmeterol or formoterol) and for 24 hours (tiotropium) prior to testing
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Arformoterol tartrate
Normal saline
Arm Description
Bronchodilator therapy with arformoterol solution 15 mcg
Placebo using normal saline
Outcomes
Primary Outcome Measures
Exercise Endurance Time
Participants were asked to exercise until symptom limitation
Secondary Outcome Measures
Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise
linear regression slope of breathlessness - time for arformoterol and for normal saline will be compared between treadmill and cycle exercise
The higher the number the worse the shortness of breath
Full Information
NCT ID
NCT00754546
First Posted
September 16, 2008
Last Updated
May 28, 2013
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00754546
Brief Title
Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD
Acronym
ARFEET
Official Title
Effects of Arformoterol on Exercise Endurance Time and Breathlessness in COPD: Cycle Ergometer vs. Treadmill
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Sumitomo Pharma America, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with COPD. The hypothesis of the study is that patients with COPD will exhibit greater improvements in exercise endurance and breathlessness with arformoterol compared with normal saline during treadmill walking than with cycle exercise.
Detailed Description
The study is a randomized trial with crossover of consecutively recruited patients with symptomatic COPD. Each patient will participate in seven visits over a 3-4 week period. At the first visit patients will provide informed consent and then be familiarized with equipment and testing protocols. At visits 2 and 3 patients will inhale 2 puffs of albuterol HFA MDI, and then perform symptom limited incremental exercise on the treadmill or cycle ergometer (randomized order); after a one hour rest, the patient will perform constant work exercise at 80-85% of peak VO2 on the same exercise mode.
At visits 4 - 7, patients will perform PFTs at baseline and at 30 and 120 minutes after inhaling arformoterol or normal saline (randomized order) and then constant work exercise on the treadmill or cycle ergometer (randomized order). Metabolic measurements will be made throughout exercise, and patients will provide continuous ratings of breathlessness and leg discomfort using a system consisting of a computer, monitor, and a mouse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
exercise;, treadmill;, cycle ergometer;, breathlessness;, leg discomfort
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arformoterol tartrate
Arm Type
Active Comparator
Arm Description
Bronchodilator therapy with arformoterol solution 15 mcg
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Placebo using normal saline
Intervention Type
Drug
Intervention Name(s)
Arformoterol tartrate
Other Intervention Name(s)
Brovana
Intervention Description
15 mcg in two ml solution administered via nebulizer
Intervention Type
Drug
Intervention Name(s)
Placebo: Normal Saline
Intervention Description
Normal saline was nebulized.
Intervention Type
Other
Intervention Name(s)
Treadmill Exercise
Intervention Type
Other
Intervention Name(s)
Cycle Exercise
Primary Outcome Measure Information:
Title
Exercise Endurance Time
Description
Participants were asked to exercise until symptom limitation
Time Frame
After one dose
Secondary Outcome Measure Information:
Title
Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise
Description
linear regression slope of breathlessness - time for arformoterol and for normal saline will be compared between treadmill and cycle exercise
The higher the number the worse the shortness of breath
Time Frame
After one dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male or female patient 50 years of age or older; diagnosis of COPD; current or ex-smoker with at least 10 pack-years of smoking; a patient-reported score for breathlessness during activities of daily living of < 9 on the self-administered computerized baseline dyspnea index; a post-bronchodilator FEV1 < 80% predicted; a post-bronchodilator FEV1/FVC ratio < 70%; and clinically stable condition.
Exclusion Criteria:
any concomitant disease that interferes with study procedures or evaluation; inability to exercise on the treadmill or cycle ergometer; inability to withhold short-acting bronchodilators for 4 hours or long-acting bronchodilators for 12 hrs (salmeterol or formoterol) and for 24 hours (tiotropium) prior to testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doanld A Mahler, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0001
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20040610
Citation
Zhang X, Waterman LA, Ward J, Baird JC, Mahler DA. Advantages of endurance treadmill walking compared with cycling to assess bronchodilator therapy. Chest. 2010 Jun;137(6):1354-61. doi: 10.1378/chest.09-2470. Epub 2009 Dec 29.
Results Reference
result
Learn more about this trial
Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD
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