Lung Diseases, ObstructiveNCT01719822
Physical Activity Augmentation Using Pedometers During Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
A study testing Yamax Digi-Walker CW-700 in people with Lung Diseases, Obstructive and Pulmonary Disease, Chronic Obstructive, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Patients with chronic lung diseases such as Chronic Obstructive Pulmonary Disease (COPD), who perform regular physical activity, have improved health and wellbeing compared with those who do little exercise. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
- What is being tested?
- Yamax Digi-Walker CW-700
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2012to Feb 2015
- 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
- All patients with COPD
Who cannot join
- Any patient in whom mobility and lower limb function have been significantly affected by a neuromuscular disease, severe peripheral vascular disease or amputation
- Any patient whom the chief investigator feels it is unsafe to exercise (eg. unstable cardiac disease)
Trial locations and contacts
1 site in 1 country.
About this study
Patients with chronic lung diseases such as Chronic Obstructive Pulmonary Disease (COPD), who perform regular physical activity, have improved health and wellbeing compared with those who do little exercise. The purpose of the study is to evaluate whether the use of a simple pedometer (step counter) to set targets for daily physical activity can encourage COPD patients referred for an 8-week pulmonary exercise based programme (PR) to be more active. The investigators also want to know whether the use of pedometers during PR can improve adherence, self-management and outcome in COPD.
- Being tested
- Yamax Digi-Walker CW-700
- Keywords
- Treatment Outcome [E01.789.800], Rehabilitation [N02.421.784], Physical Fitness [I03.621], Lung Diseases, Obstructive [C08.381.495], Pulmonary Disease, Chronic Obstructive [C08.381.495.389], Bronchitis, Chronic [C08.381.495.389.500]
- Medical subject headings
- Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Lung Diseases, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yamax Digi-Walker CW-700Device
A pedometer with a daily step count target set by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Standard 8-week pulmonary rehabilitation programme with 2 supervised sessions per week and a written home exercise plan/diary. |
| Intervention | Experimental | Standard 8-week pulmonary rehabilitation programme with 2 supervised sessions per week. In addition they will receive a pedometer with a daily step count target set by a physiotherapist and a written home exercise plan/diary. Receives: Device: Yamax Digi-Walker CW-700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of time spent in at least moderate physical activity (3>METS equivalent)
Measured: 8 weeks
Secondary outcomes (3)
Change from baseline of Incremental Shuttle Walk
Measured: 8 weeks
Change from baseline of Chronic Respiratory Disease Questionaire (CRDQ)
Measured: 8 weeks
Change from baseline of Medical Outcomes Survey Short Form 36 item questionaire SF-36
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, ObstructiveStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William DC Man, MRCP, PhD, Principal investigator, Respiratory Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust and Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719822
- Sponsor's protocol ID
- 2012LF002H
- Status last verified
- May 2015
- First submitted
- 20 Jul 2012
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Butler L, Furber S, Phongsavan P, Mark A, Bauman A. Effects of a pedometer-based intervention on physical activity levels after cardiac rehabilitation: a randomized controlled trial. J Cardiopulm Rehabil Prev. 2009 Mar-Apr;29(2):105-14. doi: 10.1097/HCR.0b013e31819a01ff.
PubMed 19305235Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.
PubMed 18029834Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Anto JM. Regular physical activity modifies smoking-related lung function decline and reduces risk of chronic obstructive pulmonary disease: a population-based cohort study. Am J Respir Crit Care Med. 2007 Mar 1;175(5):458-63. doi: 10.1164/rccm.200607-896OC. Epub 2006 Dec 7.
PubMed 17158282Nolan CM, Maddocks M, Canavan JL, Jones SE, Delogu V, Kaliaraju D, Banya W, Kon SSC, Polkey MI, Man WD. Pedometer Step Count Targets during Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 May 15;195(10):1344-1352. doi: 10.1164/rccm.201607-1372OC.
PubMed 27911566
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Augmentation Using Pedometers During Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01719822
- Acronym / sponsor ID
- 2012LF002H
- Keywords
- Treatment Outcome [E01.789.800], Rehabilitation [N02.421.784], Physical Fitness [I03.621], Lung Diseases, Obstructive [C08.381.495], Pulmonary Disease, Chronic Obstructive [C08.381.495.389], Bronchitis, Chronic [C08.381.495.389.500]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 1 Nov 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.
Patients with chronic lung diseases such as Chronic Obstructive Pulmonary Disease (COPD), who perform regular physical activity, have improved health and wellbeing compared with those who do little exercise. The purpose of the study is to evaluate whether the use of a simple pedometer (step counter) to set targets for daily physical activity can encourage COPD patients referred for an 8-week pulmonary exercise based programme (PR) to be more active. The investigators also want to know whether the use of pedometers during PR can improve adherence, self-management and outcome in COPD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Standard 8-week pulmonary rehabilitation programme with 2 supervised sessions per week and a written home exercise plan/diary. |
| Intervention | Experimental | Device: Yamax Digi-Walker CW-700Standard 8-week pulmonary rehabilitation programme with 2 supervised sessions per week. In addition they will receive a pedometer with a daily step count target set by a physiotherapist and a written home exercise plan/diary. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with COPD
Key exclusion criteria (2 listed)
- Any patient in whom mobility and lower limb function have been significantly affected by a neuromuscular disease, severe peripheral vascular disease or amputation
- Any patient whom the chief investigator feels it is unsafe to exercise (eg. unstable cardiac disease)
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 |
|---|---|---|
| Yamax Digi-Walker CW-700A pedometer with a daily step count target set by a physiotherapist. | Device | Intervention |
Primary outcome
Change from baseline of time spent in at least moderate physical activity (3>METS equivalent)
Time frame: 8 weeks
3 secondary outcomes
Change from baseline of Incremental Shuttle Walk
Time frame: 8 weeks
Change from baseline of Chronic Respiratory Disease Questionaire (CRDQ)
Time frame: 8 weeks
Change from baseline of Medical Outcomes Survey Short Form 36 item questionaire SF-36
Time frame: 8 weeks
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 13 May 2015.
- Background: PubMed 19305235Butler L, Furber S, Phongsavan P, Mark A, Bauman A. Effects of a pedometer-based intervention on physical activity levels after cardiac rehabilitation: a randomized controlled trial. J Cardiopulm Rehabil Prev. 2009 Mar-Apr;29(2):105-14. doi: 10.1097/HCR.0b013e31819a01ff.
- Background: PubMed 18029834Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.
- Background: PubMed 17158282Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Anto JM. Regular physical activity modifies smoking-related lung function decline and reduces risk of chronic obstructive pulmonary disease: a population-based cohort study. Am J Respir Crit Care Med. 2007 Mar 1;175(5):458-63. doi: 10.1164/rccm.200607-896OC. Epub 2006 Dec 7.
- Derived from this study: PubMed 27911566Nolan CM, Maddocks M, Canavan JL, Jones SE, Delogu V, Kaliaraju D, Banya W, Kon SSC, Polkey MI, Man WD. Pedometer Step Count Targets during Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 May 15;195(10):1344-1352. doi: 10.1164/rccm.201607-1372OC.
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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.
William DC Man, MRCP, PhD principal investigator
Respiratory Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust and Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yamax Digi-Walker CW-700 in people with Lung Diseases, Obstructive and Pulmonary Disease, Chronic Obstructive, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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 1 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 13 May 2015. 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 Kingdom. 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?
Change from baseline of time spent in at least moderate physical activity (3>METS equivalent) (time frame: 8 weeks). 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 NCT01719822, which also lists 4 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 13 May 2015.