Pulmonary Disease, Chronic ObstructivePhase 1/2NCT00373932
Real-Time Support for Exercise Persistence in COPD
A Phase 1/2 study testing Coached exercise persistence intervention and Self-Monitored exercise persistence intervention in people with Pulmonary Disease, Chronic Obstructive and COPD, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this exploratory study is to determine the feasibility, acceptability, and efficacy of an exercise persistence intervention for patients with chronic obstructive pulmonary disease (COPD) following pulmonary rehabilitation (PR). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, COPD, Emphysema
- What is being tested?
- Coached exercise persistence intervention and Self-Monitored exercise persistence intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Dec 2008
- Phase
- Phase 1/2
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe COPD (FEV1/FVC <70% and FEV1%<80%)
- Ability to speak, read and write English
- Age 40 or older
- Willingness to complete a 6 month program
Who cannot join
- Illnesses such as bronchiectasis, active malignancies or other end stage diseases
- Plans to continue in a maintenance program after rehabilitation.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this exploratory study is to determine the feasibility, acceptability, and efficacy of an exercise persistence intervention for patients with chronic obstructive pulmonary disease (COPD) following pulmonary rehabilitation (PR).
Read the detailed description
Exercise, a cornerstone of PR, is effective in improving dyspnea, functioning, and health related quality of life (HRQL) in patients with COPD. However, these improvements gradually dissipate following program completion. There are currently few successful interventions that support patients' persistence with community-based exercise after PR and that have closely monitored the potentially negative impact that COPD exacerbations have on exercise behaviors. Emerging technologies such as wirelessly enabled personal digital assistants (PDA) may provide an innovative means to support exercise persistence through real-time collaborative monitoring of exercise and signs and symptoms of COPD exacerbations and reinforcement to enhance exercise self-efficacy. Patient graduates of two PR programs who have COPD (n=20) will first undergo a 2-week run-in prior to being randomized to either the MOBILE (Mobilizing Support for Long-term Exercise) intervention or attention control for 6 months.
- Being tested
- Coached exercise persistence intervention, Self-Monitored exercise persistence intervention
- Keywords
- Exercise, Physical Activity, Adherence
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coached exercise persistence interventionBehavioural
Collaborative symptom and exercise monitoring and weekly reinforcement for exercise persistence from nurse coach via a mobile device and telephone.
Self-Monitored exercise persistence interventionBehavioural
Self-monitoring of symptoms and exercise using a mobile device
| Study group | Role | What they receive |
|---|---|---|
| MOBILE-A | Experimental | Coached exercise persistence intervention Receives: Behavioral: Coached exercise persistence intervention |
| MOBILE-B | Active comparator | Self-monitored exercise persistence intervention Receives: Behavioral: Self-Monitored exercise persistence intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise behavior
Measured: 3 & 6 Months
Secondary outcomes (5)
Self-efficacy for exercise
Measured: 3 & 6 Months
Perception of support
Measured: 3 & 6 Months
COPD exacerbation
Measured: 3 & 6 Months
Exercise Performance
Measured: 3 & 6 months
Health related quality of life
Measured: 3 & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Huong Q. Nguyen, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373932
- Sponsor's protocol ID
- 29494-V2
- Other IDs
- R03NR009361-01A1
- Status last verified
- Dec 2009
- First submitted
- 6 Sep 2006
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Nguyen HQ, Steele BG, Dougherty CM, Burr RL. Physical activity patterns of patients with cardiopulmonary illnesses. Arch Phys Med Rehabil. 2012 Dec;93(12):2360-6. doi: 10.1016/j.apmr.2012.06.022. Epub 2012 Jul 5.
PubMed 22772084Nguyen HQ, Gill DP, Wolpin S, Steele BG, Benditt JO. Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD. Int J Chron Obstruct Pulmon Dis. 2009;4:301-13. doi: 10.2147/copd.s6643. Epub 2009 Sep 1.
PubMed 19750190
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Support for Exercise Persistence in COPD
- ClinicalTrials.gov ID
- NCT00373932
- Acronym / sponsor ID
- 29494-V2
- Keywords
- Exercise, Physical Activity, Adherence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- May 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Sep 2006 (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.
The purpose of this exploratory study is to determine the feasibility, acceptability, and efficacy of an exercise persistence intervention for patients with chronic obstructive pulmonary disease (COPD) following pulmonary rehabilitation (PR).
Detailed description
Exercise, a cornerstone of PR, is effective in improving dyspnea, functioning, and health related quality of life (HRQL) in patients with COPD. However, these improvements gradually dissipate following program completion. There are currently few successful interventions that support patients' persistence with community-based exercise after PR and that have closely monitored the potentially negative impact that COPD exacerbations have on exercise behaviors. Emerging technologies such as wirelessly enabled personal digital assistants (PDA) may provide an innovative means to support exercise persistence through real-time collaborative monitoring of exercise and signs and symptoms of COPD exacerbations and reinforcement to enhance exercise self-efficacy. Patient graduates of two PR programs who have COPD (n=20) will first undergo a 2-week run-in prior to being randomized to either the MOBILE (Mobilizing Support for Long-term Exercise) intervention or attention control for 6 months.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOBILE-A | Experimental | Behavioral: Coached exercise persistence interventionCoached exercise persistence intervention |
| MOBILE-B | Active comparator | Behavioral: Self-Monitored exercise persistence interventionSelf-monitored exercise persistence intervention |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate to severe COPD (FEV1/FVC <70% and FEV1%<80%)
- Ability to speak, read and write English
- Age 40 or older
- Willingness to complete a 6 month program
Key exclusion criteria (2 listed)
- Illnesses such as bronchiectasis, active malignancies or other end stage diseases
- Plans to continue in a maintenance program after rehabilitation.
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 |
|---|---|---|
| Coached exercise persistence interventionCollaborative symptom and exercise monitoring and weekly reinforcement for exercise persistence from nurse coach via a mobile device and telephone. | Behavioural | MOBILE-A |
| Self-Monitored exercise persistence interventionSelf-monitoring of symptoms and exercise using a mobile device | Behavioural | MOBILE-B |
Primary outcome
Exercise behavior
Time frame: 3 & 6 Months
5 secondary outcomes
Self-efficacy for exercise
Time frame: 3 & 6 Months
Perception of support
Time frame: 3 & 6 Months
COPD exacerbation
Time frame: 3 & 6 Months
Exercise Performance
Time frame: 3 & 6 months
Health related quality of life
Time frame: 3 & 6 months
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 7 Dec 2009.
- Derived from this study: PubMed 22772084Nguyen HQ, Steele BG, Dougherty CM, Burr RL. Physical activity patterns of patients with cardiopulmonary illnesses. Arch Phys Med Rehabil. 2012 Dec;93(12):2360-6. doi: 10.1016/j.apmr.2012.06.022. Epub 2012 Jul 5.
- Derived from this study: PubMed 19750190Nguyen HQ, Gill DP, Wolpin S, Steele BG, Benditt JO. Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD. Int J Chron Obstruct Pulmon Dis. 2009;4:301-13. doi: 10.2147/copd.s6643. Epub 2009 Sep 1.
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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.
Huong Q. Nguyen, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Coached exercise persistence intervention and Self-Monitored exercise persistence intervention in people with Pulmonary Disease, Chronic Obstructive and COPD, run by University of Washington at 1 site in United States.
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 4 inclusion and 2 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 7 Dec 2009. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Exercise behavior (time frame: 3 & 6 Months). 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 NCT00373932, which also lists 2 linked publications.
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 7 Dec 2009.