COPDNCT01739751
Physical Activity Enhancement Using Pedometers in COPD
A study testing pedometers in people with COPD, run by University of Chile at 1 site in Chile.
Trial summary
Physical activity is reduced in COPD affecting morbidity and mortality and the usual advice is not good enough to increase the physical activity level. The aim of the study is to determine the effects of pedometers in the physical level in COPD patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- pedometers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChile
- Study dates
- Jan 2011to Apr 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosis according to GOLD guidelines
- Pack year Index equal or more than 10
- smoking suspended > 2 months
- older than 40 years old,
Who cannot join
- any chronic condition that does not allow walking
- participation in a rehabilitation program
- Acute exacerbation in the last two months
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clínico Universidad de Chile
Santiago, Santiago Metropolitan, 8380456
About this study
Official title: Effect of a Program of Physical Activity Enhancement Using Pedometers in Chronic Obstructive Pulmonary Disease
Physical activity is reduced in COPD affecting morbidity and mortality and the usual advice is not good enough to increase the physical activity level. The aim of the study is to determine the effects of pedometers in the physical level in COPD patients.
Read the detailed description
Physical activity is reduced in COPD patients and has a negative effect in the morbidity and mortality of this condition. Unfortunately, usual advice is not good enough to reverse the sedentary condition in COPD patients. Pedometers are broadly used to measure and to enhance physical activity in COPD but their effects in COPD are not well known. The aim of the study is to determine the effects of a program using pedometers as a feedback in stable ex smokers COPD patients. Patients are recruited for a 3 months individual program promoting daily physical activity enhancement and are randomly assigned either to a pedometer-based program (experimental group) or to usual care (control group, the measurements at the beginning and at the end of the study are: anthropometrics, Spirometry, dyspnea, quality of life, exercise capacity and the average one week daily steps. Also the number of acute exacerbations during the follow up are recorded.
- Conditions
- COPD
- Being tested
- pedometers
- Keywords
- COPD, Physical activity, Pedometers, steps, non pharmacological treatment, rehabilitation, exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pedometersDevice
Also called PD 724
portable device that estimate the number of steps walked daily
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients without feedback of a pedometers, followed for 3 months |
| Pedometers | Experimental | With a program of physical activity enhancement using pedometers as a feedback Receives: Device: pedometers |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect in average steps walked daily
Comparison between both groups in the difference of the average of steps walked daily at final evaluation with the basal evaluation
Measured: 3 months
Secondary outcomes (3)
six minute walking distance
Comparison between groups in the difference of the distance( meters) in the six minute walking test in the final evaluation with the basal evaluation
Measured: 3 months
score in the Saint George Respiratory Questionnaire
Comparison between groups in the difference of the score of the SGRQ at the final evaluation in comparison with the basal evaluation
Measured: 3 months
Score of the COPD Assessment Test (CAT)
Comparison between groups in the difference of the CAT score at the final evaluation with the basal evaluation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startJan 2011
- Primary completionMar 2013 (estimated)
- Study completionApr 2013 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Responsible party
- Principal investigator, Dr. Laura Mendoza, University of Chile
- Investigators
- Laura Mendoza, MD, Principal investigator, Hospital Clínico University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739751
- Sponsor's protocol ID
- SA10i20022
- Status last verified
- Nov 2012
- First submitted
- 29 Nov 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bravata 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 18029834
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Program of Physical Activity Enhancement Using Pedometers in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01739751
- Acronym / sponsor ID
- SA10i20022
- Conditions
- COPD
- Keywords
- COPD, Physical activity, Pedometers, steps, non pharmacological treatment, rehabilitation, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 3 Dec 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.
Physical activity is reduced in COPD affecting morbidity and mortality and the usual advice is not good enough to increase the physical activity level. The aim of the study is to determine the effects of pedometers in the physical level in COPD patients.
Detailed description
Physical activity is reduced in COPD patients and has a negative effect in the morbidity and mortality of this condition. Unfortunately, usual advice is not good enough to reverse the sedentary condition in COPD patients. Pedometers are broadly used to measure and to enhance physical activity in COPD but their effects in COPD are not well known. The aim of the study is to determine the effects of a program using pedometers as a feedback in stable ex smokers COPD patients. Patients are recruited for a 3 months individual program promoting daily physical activity enhancement and are randomly assigned either to a pedometer-based program (experimental group) or to usual care (control group, the measurements at the beginning and at the end of the study are: anthropometrics, Spirometry, dyspnea, quality of life, exercise capacity and the average one week daily steps. Also the number of acute exacerbations during the follow up are recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients without feedback of a pedometers, followed for 3 months |
| Pedometers | Experimental | Device: pedometersWith a program of physical activity enhancement using pedometers as a feedback |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD diagnosis according to GOLD guidelines
- Pack year Index equal or more than 10
- smoking suspended > 2 months
- older than 40 years old,
Key exclusion criteria (3 listed)
- any chronic condition that does not allow walking
- participation in a rehabilitation program
- Acute exacerbation in the last two months
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 |
|---|---|---|
| pedometersAlso: PD 724portable device that estimate the number of steps walked daily | Device | Pedometers |
Primary outcome
effect in average steps walked daily
Time frame: 3 months
Comparison between both groups in the difference of the average of steps walked daily at final evaluation with the basal evaluation
3 secondary outcomes
six minute walking distance
Time frame: 3 months
score in the Saint George Respiratory Questionnaire
Time frame: 3 months
Score of the COPD Assessment Test (CAT)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- 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.
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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.
Laura Mendoza, MD principal investigator
Hospital Clínico University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pedometers in people with COPD, run by University of Chile at 1 site in Chile.
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 3 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: status not confirmed, as of the sponsor's last update on 4 Dec 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 Chile. 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?
Results are not available in the source record.
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?
effect in average steps walked daily (time frame: 3 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 NCT01739751, 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 4 Dec 2012.