Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD (ARFEET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00754546
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : May 29, 2013
Last Update Posted : May 29, 2013
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Arformoterol tartrate Drug: Placebo: Normal Saline Other: Treadmill Exercise Other: Cycle Exercise Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Arformoterol on Exercise Endurance Time and Breathlessness in COPD: Cycle Ergometer vs. Treadmill
Study Start Date : August 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Arformoterol tartrate
Bronchodilator therapy with arformoterol solution 15 mcg
Drug: Arformoterol tartrate
15 mcg in two ml solution administered via nebulizer
Other Name: Brovana

Other: Treadmill Exercise
Other: Cycle Exercise
Placebo Comparator: Normal saline
Placebo using normal saline
Drug: Placebo: Normal Saline
Normal saline was nebulized.

Other: Treadmill Exercise
Other: Cycle Exercise

Primary Outcome Measures :
  1. Exercise Endurance Time [ Time Frame: After one dose ]
    Participants were asked to exercise until symptom limitation

Secondary Outcome Measures :
  1. Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise [ Time Frame: After one dose ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00754546

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Principal Investigator: Doanld A Mahler, MD Dartmouth-Hitchcock Medical Center

Publications of Results:
Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00754546     History of Changes
Other Study ID Numbers: 21261
First Posted: September 18, 2008    Key Record Dates
Results First Posted: May 29, 2013
Last Update Posted: May 29, 2013
Last Verified: May 2013

Keywords provided by Dartmouth-Hitchcock Medical Center:
cycle ergometer;
leg discomfort

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action