Chronic Obstructive Pulmonary DiseaseNCT00657293
Arm Training in Patients With Chronic Obstructive Pulmonary Disease
A study testing Arm training program in people with Chronic Obstructive Pulmonary Disease, run by West Park Healthcare Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Arm training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Arm training program, Purdue pegboard test (sham)
- Keywords
- COPD, arm training, dyspnoea, quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm training programBehavioural
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.
Purdue pegboard test (sham)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| C | Sham comparator | In an attempt to make the groups comparable in terms of attention, the control group will receive a sham. Receives: Behavioral: Purdue pegboard test (sham) |
| ATP | Active comparator | Patients will undergo a specific arm training program (ATP). Receives: Behavioral: Arm training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measures, dyspnoea during activities of daily living, fatigue, health-related quality of life, unsupported arm exercise capacity, arm function and peripheral muscle force
Measured: 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 (1)
Peak cardiorespiratory responses during incremental unsupported upper limb exercise test
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Investigators
- Roger Goldstein, M.D., Principal investigator, West Park Healthcare CentreDina Brooks, Ph.D., Principal investigator, West Park Healthcare CentreTania Janaudis-Ferreira, Msc, Study chair, West Park Healthcare CentreKylie Hill, Ph.D., Study chair, West Park Healthcare CentreTom Dolmage, Msc, Study chair, West Park Healthcare CentreMarla Beauchamp, Msc, Study chair, West Park Healthcare CentreKarin Wadell, Ph.D., Study chair, Umea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657293
- Sponsor's protocol ID
- Goldstein_Arm1207
- Status last verified
- Feb 2010
- First submitted
- 8 Apr 2008
- Last updated
- 22 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arm Training in COPD: Short and Medium Term Effects on Dyspnoea, Health-related Quality of Life, Arm Function and Arm Exercise Capacity.
- ClinicalTrials.gov ID
- NCT00657293
- Acronym / sponsor ID
- Goldstein_Arm1207
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, arm training, dyspnoea, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C | Sham comparator | Behavioral: Purdue pegboard test (sham)In an attempt to make the groups comparable in terms of attention, the control group will receive a sham. |
| ATP | Active comparator | Behavioral: Arm training programPatients will undergo a specific arm training program (ATP). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm training programPatients 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. | Behavioural | ATP |
| 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. | Behavioural | C |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Goldstein, M.D. principal investigator
West Park Healthcare Centre
Dina Brooks, Ph.D. principal investigator
West Park Healthcare Centre
Tania Janaudis-Ferreira, Msc study chair
West Park Healthcare Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm training program in people with Chronic Obstructive Pulmonary Disease, run by West Park Healthcare Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2010.