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Arm Training in Patients With Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Arm training program
Purdue pegboard test (sham)
Sponsored by
West Park Healthcare Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, arm training, dyspnoea, quality of life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West Park Healthcare Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

C

ATP

Arm Description

In an attempt to make the groups comparable in terms of attention, the control group will receive a sham.

Patients will undergo a specific arm training program (ATP).

Outcomes

Primary Outcome Measures

Feasibility measures, dyspnoea during activities of daily living, fatigue, health-related quality of life, unsupported arm exercise capacity, arm function and peripheral muscle force

Secondary Outcome Measures

Peak cardiorespiratory responses during incremental unsupported upper limb exercise test

Full Information

First Posted
April 8, 2008
Last Updated
February 19, 2010
Sponsor
West Park Healthcare Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00657293
Brief Title
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

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
West Park Healthcare Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, arm training, dyspnoea, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C
Arm Type
Sham Comparator
Arm Description
In an attempt to make the groups comparable in terms of attention, the control group will receive a sham.
Arm Title
ATP
Arm Type
Active Comparator
Arm Description
Patients will undergo a specific arm training program (ATP).
Intervention Type
Behavioral
Intervention Name(s)
Arm training program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Purdue pegboard test (sham)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility measures, dyspnoea during activities of daily living, fatigue, health-related quality of life, unsupported arm exercise capacity, arm function and peripheral muscle force
Time Frame
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 Outcome Measure Information:
Title
Peak cardiorespiratory responses during incremental unsupported upper limb exercise test
Time Frame
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.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Goldstein, M.D.
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dina Brooks, Ph.D.
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tania Janaudis-Ferreira, Msc
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kylie Hill, Ph.D.
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tom Dolmage, Msc
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marla Beauchamp, Msc
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karin Wadell, Ph.D.
Organizational Affiliation
Umea University
Official's Role
Study Chair
Facility Information:
Facility Name
West Park Healthcare Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 2J5
Country
Canada

12. IPD Sharing Statement

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Arm Training in Patients With Chronic Obstructive Pulmonary Disease

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