COPDNCT01564043
Internet Walking Program and Pedometer in Chronic Obstructive Pulmonary Disease
A study testing website and pedometer in people with COPD and Internet Access, run by VA Boston Healthcare System at 1 site in United States.
Trial summary
Higher levels of physical activity are associated with better functional status, fewer hospital admissions, and lower mortality. The investigators studied the feasibility and safety of a novel program that combines a pedometer with a website to increase walking. This is a pilot study. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- COPD, Internet Access
- What is being tested?
- website and pedometer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Nov 2011
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD
- able to ambulate
- internet access
Who cannot join
- current pulmonary rehab
Trial locations and contacts
1 site in 1 country.
United States1 site
VABoston Healthcare System
Boston, Massachusetts, 02132
About this study
Higher levels of physical activity are associated with better functional status, fewer hospital admissions, and lower mortality. The investigators studied the feasibility and safety of a novel program that combines a pedometer with a website to increase walking. This is a pilot study.
- Conditions
- COPD, Internet Access
- Being tested
- website and pedometer
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
website and pedometerBehavioural
use of pedometer and website
| Study group | Role | What they receive |
|---|---|---|
| website and pedometer | Experimental | Not described Receives: Behavioral: website and pedometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily step count
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionNov 2011
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 COPDStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Boston Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- University of Michigan, VA Ann Arbor Healthcare System
- Responsible party
- Principal investigator, Marilyn Moy, VA Boston Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564043
- Sponsor's protocol ID
- VABHS2328
- Status last verified
- Mar 2012
- First submitted
- 23 Mar 2012
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Moy ML, Weston NA, Wilson EJ, Hess ML, Richardson CR. A pilot study of an Internet walking program and pedometer in COPD. Respir Med. 2012 Sep;106(9):1342-50. doi: 10.1016/j.rmed.2012.06.013. Epub 2012 Jul 12.
PubMed 22795984
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Walking Program and Pedometer in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01564043
- Acronym / sponsor ID
- VABHS2328
- Conditions
- COPD, Internet Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- VA Boston Healthcare SystemUS federal agency
- Collaborators
- University of Michigan, VA Ann Arbor Healthcare System
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 27 Mar 2012 (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.
Higher levels of physical activity are associated with better functional status, fewer hospital admissions, and lower mortality. The investigators studied the feasibility and safety of a novel program that combines a pedometer with a website to increase walking. This is a pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| website and pedometer | Experimental | Behavioral: website and pedometer |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD
- able to ambulate
- internet access
Key exclusion criteria (1 listed)
- current pulmonary rehab
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 |
|---|---|---|
| website and pedometeruse of pedometer and website | Behavioural | website and pedometer |
Primary outcome
Daily step count
Time frame: 90 days
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 27 Mar 2012.
- Derived from this study: PubMed 22795984Moy ML, Weston NA, Wilson EJ, Hess ML, Richardson CR. A pilot study of an Internet walking program and pedometer in COPD. Respir Med. 2012 Sep;106(9):1342-50. doi: 10.1016/j.rmed.2012.06.013. Epub 2012 Jul 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing website and pedometer in people with COPD and Internet Access, run by VA Boston Healthcare System 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 3 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 27 Mar 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 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.
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?
Daily step count (time frame: 90 days). 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 NCT01564043, 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 27 Mar 2012.