Chronic Obstructive Pulmonary DiseaseNCT01768754
Walking Speeds in Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by West Park Healthcare Centre at 1 site in Canada.
Trial summary
A growing body of evidence suggests that in individuals with chronic lung disease their walk speed is related to their daily function and quality of life. It is possible to assess their usual (routine) and fast walking speeds by getting them to walk in a flat hallway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Usual and Fast Walking Speeds
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Mar 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stable moderate-severe COPD will be recruited from those under the care of a respirologist at West Park Health Care Centre
Who may be able to join
- Clinical and spirometric diagnosis of COPD
- Able to provide written informed consent
Who cannot join
- Unstable cardiovascular disease
- Acute respiratory exacerbation within 4 weeks
- Neurologic or orthopedic limitation to walking
- Inability to comprehend instructions in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repeatability and Utility of the Usual and Fast Walking Speeds in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A growing body of evidence suggests that in individuals with chronic lung disease their walk speed is related to their daily function and quality of life. It is possible to assess their usual (routine) and fast walking speeds by getting them to walk in a flat hallway.
In individuals with chronic lung disease, we anticipate that their usual walk speed will be helpful in exercise prescription and use in multidimensional scoring systems. However, it is important to first determine the measurement properties of these two walk speeds.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Usual and Fast Walking Speeds
- Keywords
- Exercise testing, Functional status, Pulmonary rehabilitation
- 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.
Usual and Fast Walking SpeedsBehavioural
Stable patients with chronic obstructive pulmonary disease will demonstrate their usual and fast walking speeds over a 30 m course, with speed calculated over the middle 10 m using optical sensors. The test will be repeated after a 5 minute rest; this procedure will then be repeated on two subsequent days, at the same time of day, within one week.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Usual and Fast Walking Speeds Receives: Behavioral: Usual and Fast Walking Speeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of repeatability for usual and fast walk speeds
Participants will be asked to demonstrate their usual and fast walk speeds over the middle 10 meters of a 30 meter straight track using optical sensors and a hand-held stopwatch. Participants will be instructed to walk at their 'usual' and 'fast' speeds as standardized instructions. The walk test will be repeated after a 5 minute rest and then repeated on two subsequent days, at the same time of day, within one week. This will be simply observational in nature with no planned intervention aside for controlling walking environment.
The primary outcome is going to report a change in walk speeds from baseline and at 1 and 2 days using repeated measures as described by Bland and Altman (reference below).
Measured: At baseline and over 1 week period.
Secondary outcomes (2)
Agreement in walk speeds between optical sensors and stopwatch
Assess agreement between the use of optical sensors and stop watch time for the usual and fast walk speeds.
Measured: Baseline and over 1 week of testing.
Agreement in the Bode Index using six minute walk distance and usual walk speed.
To assess agreement in the calculated Bode Index using the six minute walk distance versus estimated usual walk speed distance over 6 minutes.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startJul 2012
- Primary completionFeb 2013
- Study completionMar 2013
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 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
- Roger Goldstein, MD, FRCPC, Principal investigator, Westpark Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768754
- Sponsor's protocol ID
- Goldstein_Walk_COPD
- Status last verified
- Mar 2013
- First submitted
- 9 Jan 2013
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. doi: 10.1177/096228029900800204.
PubMed 10501650
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability and Utility of the Usual and Fast Walking Speeds in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01768754
- Acronym / sponsor ID
- Goldstein_Walk_COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Exercise testing, Functional status, Pulmonary rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 Jan 2013 (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.
A growing body of evidence suggests that in individuals with chronic lung disease their walk speed is related to their daily function and quality of life. It is possible to assess their usual (routine) and fast walking speeds by getting them to walk in a flat hallway.
In individuals with chronic lung disease, we anticipate that their usual walk speed will be helpful in exercise prescription and use in multidimensional scoring systems. However, it is important to first determine the measurement properties of these two walk speeds.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Behavioral: Usual and Fast Walking SpeedsUsual and Fast Walking Speeds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable moderate-severe COPD will be recruited from those under the care of a respirologist at West Park Health Care Centre
Key inclusion criteria (2 listed)
- Clinical and spirometric diagnosis of COPD
- Able to provide written informed consent
Key exclusion criteria (4 listed)
- Unstable cardiovascular disease
- Acute respiratory exacerbation within 4 weeks
- Neurologic or orthopedic limitation to walking
- Inability to comprehend instructions in English
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 |
|---|---|---|
| Usual and Fast Walking SpeedsStable patients with chronic obstructive pulmonary disease will demonstrate their usual and fast walking speeds over a 30 m course, with speed calculated over the middle 10 m using optical sensors. The test will be repeated after a 5 minute rest; this procedure will then be repeated on two subsequent days, at the same time of day, within one week. | Behavioural | COPD patients |
Primary outcome
Coefficient of repeatability for usual and fast walk speeds
Time frame: At baseline and over 1 week period.
Participants will be asked to demonstrate their usual and fast walk speeds over the middle 10 meters of a 30 meter straight track using optical sensors and a hand-held stopwatch. Participants will be instructed to walk at their 'usual' and 'fast' speeds as standardized instructions. The walk test will be repeated after a 5 minute rest and then repeated on two subsequent days, at the same time of day, within one week. This will be simply observational in nature with no planned intervention aside for controlling walking environment. The primary outcome is going to report a change in walk speeds from baseline and at 1 and 2 days using repeated measures as described by Bland and Altman (reference below).
2 secondary outcomes
Agreement in walk speeds between optical sensors and stopwatch
Time frame: Baseline and over 1 week of testing.
Agreement in the Bode Index using six minute walk distance and usual walk speed.
Time frame: Baseline
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 12 Mar 2013.
- Background: PubMed 10501650Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. doi: 10.1177/096228029900800204.
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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.
Roger Goldstein, MD, FRCPC principal investigator
Westpark Healthcare Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 4 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 12 Mar 2013. 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. 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?
Coefficient of repeatability for usual and fast walk speeds (time frame: At baseline and over 1 week period.). 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 NCT01768754, 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 12 Mar 2013.