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

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ClinicalTrials.gov Identifier: NCT00754546
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : May 29, 2013
Last Update Posted : May 29, 2013
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: Arformoterol tartrate
Drug: Placebo: Normal Saline
Other: Treadmill Exercise
Other: Cycle Exercise
Enrollment 20
Recruitment Details Participants recruited from a specialty clinic in Lebanon, NH, between August 1, 2008 to May 1, 2009.
Pre-assignment Details 27 particpants recruited; 27 particpants screened; 5 excluded because they did not meet inclusion criteria; 2 patients withdrew consent after visit 1.
Arm/Group Title All Participants
Hide Arm/Group Description

All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:

Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline

Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description

All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:

Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  60.0%
>=65 years
8
  40.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
64  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Exercise Endurance Time
Hide Description Participants were asked to exercise until symptom limitation
Time Frame After one dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants determined by previous studies. Analysis was intention to treat
Arm/Group Title Treadmill Exercise With the Active Comparator Cycle Exercise With the Active Comparator Treadmill Exercise With the Placebo Comparator Cycle Exercise With the Placebo Comparator
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 20 20 20
Mean (Standard Deviation)
Unit of Measure: seconds
490  (258) 333  (158) 472  (258) 362  (104)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treadmill Exercise With the Active Comparator, Cycle Exercise With the Active Comparator, Treadmill Exercise With the Placebo Comparator, Cycle Exercise With the Placebo Comparator
Comments

ANOVA was used to examine the interaction between mode of exercise and treatment effect.

Twenty patients were considered adequate to provide a power of 85% with an alpha of 0.05.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treadmill Exercise With the Active Comparator, Cycle Exercise With the Active Comparator, Treadmill Exercise With the Placebo Comparator, Cycle Exercise With the Placebo Comparator
Comments Comparing arformoterol with placebo with treadmill exercise
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treadmill Exercise With the Active Comparator, Cycle Exercise With the Active Comparator, Treadmill Exercise With the Placebo Comparator, Cycle Exercise With the Placebo Comparator
Comments Arformoterol versus normal saline with cycle exercise
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treadmill Exercise With the Active Comparator Cycle Exercise With the Active Comparator Treadmill Exercise With the Placebo Comparator Cycle Exercise With the Placebo Comparator
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 20 20 20
Least Squares Mean (Standard Deviation)
Unit of Measure: breathlessness units/min
1.27  (0.56) 1.79  (1.05) 1.42  (0.97) 1.49  (0.59)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treadmill Exercise With the Active Comparator Cycle Exercise With the Active Comparator Treadmill Exercise With the Placebo Comparator Cycle Exercise With the Placebo Comparator
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Treadmill Exercise With the Active Comparator Cycle Exercise With the Active Comparator Treadmill Exercise With the Placebo Comparator Cycle Exercise With the Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treadmill Exercise With the Active Comparator Cycle Exercise With the Active Comparator Treadmill Exercise With the Placebo Comparator Cycle Exercise With the Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Treadmill Exercise With the Active Comparator Cycle Exercise With the Active Comparator Treadmill Exercise With the Placebo Comparator Cycle Exercise With the Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Study completed with no reported adverse effects. One limitation of the study is frequent exercise tests involving 7 visits for each participant
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Donald A. Mahler, M.D.
Organization: Dartmouth-Hitchcock Medical Center
Phone: 603 650-5533
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00754546     History of Changes
Other Study ID Numbers: 21261
First Submitted: September 16, 2008
First Posted: September 18, 2008
Results First Submitted: August 3, 2009
Results First Posted: May 29, 2013
Last Update Posted: May 29, 2013