Chronic Obstructive Pulmonary DiseaseNCT00836108
Unsupported Arm Exercise and Breathing Strategy in Patients With Chronic Obstructive Pulmonary Disease
A study testing breathing strategy in people with Chronic Obstructive Pulmonary Disease, run by West Park Healthcare Centre at 1 site in Canada.
Trial summary
Controlling the way people with lung problems breathe during arm exercises may reduce their breathlessness during activities of daily living that require them to lift their arms (i.e. brushing their hair, putting groceries away on high shelves). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- breathing strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to May 2012
- 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
- diagnosis of COPD including forced expiratory volume in one second < 80% predicted normal
- presence of lung hyperinflation at rest
Who cannot join
- musculoskeletal or neurological condition which could adversely affect arm activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unsupported Arm Exercise and Breathing Strategy in Patients With Chronic
Controlling the way people with lung problems breathe during arm exercises may reduce their breathlessness during activities of daily living that require them to lift their arms (i.e. brushing their hair, putting groceries away on high shelves). The main aim of this study is to determine the effects of specific breathing strategies during arm exercise on dyspnoea in patients with chronic lung disease. Coordinating inspiration with the action of arm elevation will reduce dyspnoea during a rhythmic overhead arm activity
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- breathing strategy
- Keywords
- Lung Diseases, Obstructive, Breathing Exercises, Exercise Tolerance, Dyspnea, Arm Exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing strategyBehavioural
Subjects will practice a rhythmic overhead arm exercise, during which they will be taught to inspire when they elevate their arms or they will be taught to expire when they elevate their arms or, a third group, will practice a rhythmic overhead arm exercise, during which they will not be provided with any instruction regarding a specific breathing pattern. The arm exercise practiced by all groups will be identical.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sham comparator | spontaneous Receives: Behavioral: breathing strategy |
| 2 | Experimental | coordinating arm elevation with inspiration Receives: Behavioral: breathing strategy |
| 3 | Experimental | coordinating arm elevation with expiration Receives: Behavioral: breathing strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnoea during arm exercise
Measured: 1 week
Secondary outcomes (1)
Arm exercise endurance
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger Goldstein, West Park Healthcare Centre
- Investigators
- Dina Brooks, PhD, Principal investigator, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836108
- Sponsor's protocol ID
- RG20080707ArmStrategy
- Status last verified
- Jul 2012
- First submitted
- 3 Feb 2009
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Dolmage TE, Janaudis-Ferreira T, Hill K, Price S, Brooks D, Goldstein RS. Arm elevation and coordinated breathing strategies in patients with COPD. Chest. 2013 Jul;144(1):128-135. doi: 10.1378/chest.12-2467.
PubMed 23370697
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unsupported Arm Exercise and Breathing Strategy in Patients With Chronic
- ClinicalTrials.gov ID
- NCT00836108
- Acronym / sponsor ID
- RG20080707ArmStrategy
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Lung Diseases, Obstructive, Breathing Exercises, Exercise Tolerance, Dyspnea, Arm Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Feb 2009 (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.
Controlling the way people with lung problems breathe during arm exercises may reduce their breathlessness during activities of daily living that require them to lift their arms (i.e. brushing their hair, putting groceries away on high shelves). The main aim of this study is to determine the effects of specific breathing strategies during arm exercise on dyspnoea in patients with chronic lung disease. Coordinating inspiration with the action of arm elevation will reduce dyspnoea during a rhythmic overhead arm activity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Sham comparator | Behavioral: breathing strategyspontaneous |
| 2 | Experimental | Behavioral: breathing strategycoordinating arm elevation with inspiration |
| 3 | Experimental | Behavioral: breathing strategycoordinating arm elevation with expiration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of COPD including forced expiratory volume in one second < 80% predicted normal
- presence of lung hyperinflation at rest
Key exclusion criteria (1 listed)
- musculoskeletal or neurological condition which could adversely affect arm activity
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 |
|---|---|---|
| breathing strategySubjects will practice a rhythmic overhead arm exercise, during which they will be taught to inspire when they elevate their arms or they will be taught to expire when they elevate their arms or, a third group, will practice a rhythmic overhead arm exercise, during which they will not be provided with any instruction regarding a specific breathing pattern. The arm exercise practiced by all groups will be identical. | Behavioural | 1, 2, 3 |
Primary outcome
Dyspnoea during arm exercise
Time frame: 1 week
1 secondary outcome
Arm exercise endurance
Time frame: 1 week
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 11 Jul 2012.
- Derived from this study: PubMed 23370697Dolmage TE, Janaudis-Ferreira T, Hill K, Price S, Brooks D, Goldstein RS. Arm elevation and coordinated breathing strategies in patients with COPD. Chest. 2013 Jul;144(1):128-135. doi: 10.1378/chest.12-2467.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Dina Brooks, PhD principal investigator
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 breathing strategy 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 2 inclusion and 1 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 11 Jul 2012. 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?
Dyspnoea during arm exercise (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00836108, which also lists 1 linked publication.
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 11 Jul 2012.