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| Sponsor: | West Park Healthcare Centre |
|---|---|
| Information provided by: | West Park Healthcare Centre |
| ClinicalTrials.gov Identifier: | NCT00657293 |
Purpose
Patients with chronic lung disease often report shortness of breath when they use their arms for simple activities of daily living such as dressing, lifting, shaving, bathing and brushing their hair and teeth. The best type of arm training for these patients is still unknown.
The objectives of this study are to:
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease |
Behavioral: Arm training program Behavioral: Purdue pegboard test (sham) |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Arm Training in COPD: Short and Medium Term Effects on Dyspnoea, Health-Related Quality of Life, Arm Function and Arm Exercise Capacity. |
| Estimated Enrollment: | 34 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
C: Sham Comparator
In an attempt to make the groups comparable in terms of attention, the control group will receive a sham.
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Behavioral: Purdue pegboard test (sham)
In an attempt to make the groups comparable in terms of attention, the control group will perform the purdue pegboard test of finger dexterity. The tasks will be performed in a sitting position with the arms supported on a table. This test will consist of 4 timed tasks where as many pins as possible will be placed on a pegboard in a given time. Performance of the pegboard test is likely to improve with practice which may serve to motivate the patients to continue practicing over the 6-week period. Subjects will perform this activity 3 times per week with supervision provided by a physiotherapist.
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ATP: Active Comparator
Patients will undergo a specific arm training program (ATP).
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Behavioral: Arm training program
Patients will undergo a specific arm training program (ATP) three times a week for the duration of the 6 week program. The ATP will consist predominantly of resistance exercises. Muscle groups targeted during the ATP will include deltoid, biceps and triceps, pectoralis and latissimus. Subjects will train using multi station gym equipment and free weights.
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Chronic obstructive pulmonary disease (COPD) is a common condition throughout Canada and the rest of the world. Patients with COPD often describe of breathlessness that makes it difficult for them to participate in physical activity. Specifically, patients often report shortness of breath when they use their arms for simple activities of daily living such as dressing, lifting and bathing. Exercise training has been shown to reduce breathlessness in people with COPD. Compared with studies that have looked at the effects of exercise using the leg muscles, studies that focus on training the arm muscles in people with COPD are sparse. Although earlier work shows that arm training increases arm exercise capacity, the effects on other measures such as breathlessness are not clear. Therefore, the objectives of this study are; (i) to develop a feasible and safe arm training program (ATP) for patients with COPD based on the best available evidence, (ii) to examine the effectiveness of this ATP on breathlessness during activities of daily living, health-related quality of life, arm function and arm exercise capacity, (iii) to examine the physiological mechanisms underpinning any change in these outcomes in response to the ATP.
Patients with COPD will be assigned by chance to either a treatment or control group. All patients in both groups will complete the 6-week pulmonary rehabilitation (PR) program that is well-established at our centre (West Park). During this program all patients will complete leg exercises, such as walking or cycling, and receive education about how to best manage their disease. In addition to this PR program, the treatment group will complete a specific ATP involving overhead arm exercises and free weights. The control group will undergo a "sham" ATP consisting of finger exercises. Before and after the ATP we will collect measures of; (i) breathlessness during activities of daily living, fatigue and quality of life, (ii) arm exercise capacity, (iii) arm function and, (iv) arm muscle force. During the tests of arm exercise capacity a special machine (breathing-gas analysis system) will be worn. Measurements will be compared between the treatment and control groups before, immediately after the ATP and also 3 months after completing the ATP.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tania Janaudis-Ferreira, MSc | 1 416 243 3600 ext 2518 | tania.janaudis.ferreira@physiother.umu.se |
| Contact: Dina Brooks, PhD | 1 416 978 1739 | dina.brooks@utoronto.ca |
| Canada, Ontario | |
| West Park Healthcare Centre | Recruiting |
| Toronto, Ontario, Canada, M6M 2J5 | |
| Contact: Tania Ferreira, MSc 416 243 3600 ext 2518 tania.janaudis@physiother.umu.se | |
| Principal Investigator: Roger Goldstein, M.D. | |
| Principal Investigator: | Roger Goldstein, M.D. | West Park Healthcare Centre |
| Principal Investigator: | Dina Brooks, Ph.D. | West Park Healthcare Centre |
| Study Chair: | Tania Janaudis-Ferreira, Msc | West Park Healthcare Centre |
| Study Chair: | Kylie Hill, Ph.D. | West Park Healthcare Centre |
| Study Chair: | Tom Dolmage, Msc | West Park Healthcare Centre |
| Study Chair: | Marla Beauchamp, Msc | West Park Healthcare Centre |
| Study Chair: | Karin Wadell, Ph.D. | Umea University |
More Information
| Responsible Party: | West Park Healthcare Centre ( Dr. Roger Goldstein ) |
| Study ID Numbers: | Goldstein_Arm1207 |
| Study First Received: | April 8, 2008 |
| Last Updated: | June 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00657293 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
|
COPD arm training dyspnoea quality of life |
|
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |