Clinical trial NCT00657293: Arm Training in Patients With Chronic Obstructive Pulmonary Disease
Official title: Arm Training in COPD: Short and Medium Term Effects on Dyspnoea, Health-related Quality of Life, Arm Function and Arm Exercise Capacity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
arm training
dyspnoea
quality of life
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

* develop a feasible and safe arm training program (ATP) for these patients;
* examine the effects of this ATP on quality of life, arm function, arm exercise capacity and symptoms during activities of daily living;
* examine the effects of ATP on breathing responses during arm exercises.

Detailed description: 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 criteria: Inclusion Criteria:

* a diagnosis of COPD
* a forced expiratory volume in one second (FEV1) of less than 80% the predicted normal value
* must report dyspnoea during at least one activity of daily living that requires arm activity
* must have a smoking history greater than 10 pack years and
* must be able to provide written informed consent

Exclusion Criteria:

* acute exacerbation of COPD that required a change in pharmacological management within the preceding two months
* an inability to understand English
* cognitive impairment
* requirement for mechanical ventilation for all or part of the day
* tapering doses of oral corticosteroids or xanthines
* evidence of a musculoskeletal or neurological condition which could adversely affect arm exercise performance
* symptomatic ischemic cardiac disease
* a history of previous lung surgery and alpha1 antitrypsin deficient emphysema

Primary outcomes:
measure: Feasibility measures, dyspnoea during activities of daily living, fatigue, health-related quality of life, unsupported arm exercise capacity, arm function and peripheral muscle force
timeFrame: Primary outcome measures will be collected before PR program, on completion of the PR program (at 6 weeks) and at three months following completion of the PR program.
Secondary outcomes:
measure: Peak cardiorespiratory responses during incremental unsupported upper limb exercise test
timeFrame: Secondary outcome measures will be collected before PR program, on completion of the PR program (at 6 weeks) and at three months following completion of the PR program.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
affiliation: West Park Healthcare Centre
name: Roger Goldstein, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: West Park Healthcare Centre
name: Dina Brooks, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: West Park Healthcare Centre
name: Tania Janaudis-Ferreira, Msc
role: STUDY_CHAIR
affiliation: West Park Healthcare Centre
name: Kylie Hill, Ph.D.
role: STUDY_CHAIR
affiliation: West Park Healthcare Centre
name: Tom Dolmage, Msc
role: STUDY_CHAIR
affiliation: West Park Healthcare Centre
name: Marla Beauchamp, Msc
role: STUDY_CHAIR
affiliation: Umea University
name: Karin Wadell, Ph.D.
role: STUDY_CHAIR
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