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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01768754
Other study ID # Goldstein_Walk_COPD
Secondary ID
Status Completed
Phase N/A
First received January 9, 2013
Last updated March 8, 2013
Start date July 2012
Est. completion date March 2013

Study information

Verified date March 2013
Source West Park Healthcare Centre
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review CommitteeCanada: Health CanadaCanada: Ministry of Health & Long Term Care, Ontario
Study type Observational

Clinical 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.

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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date March 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical and spirometric diagnosis of COPD

- Able to provide written informed consent

Exclusion Criteria:

- Unstable cardiovascular disease

- Acute respiratory exacerbation within 4 weeks

- Neurologic or orthopedic limitation to walking

- Inability to comprehend instructions in English

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Usual and Fast Walking Speeds
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.

Locations

Country Name City State
Canada Westpark Health Care Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
West Park Healthcare Centre

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Precision of achieving a targeted endurance time using the usual and fast walking speeds. The usual and fast walk speeds will be used to predict the test speed for a high-intensity constant-speed endurance test that will achieve an acceptable endurance time of 2-15 minutes. Baseline No
Primary 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).
At baseline and over 1 week period. No
Secondary 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. Baseline and over 1 week of testing. No
Secondary 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. Baseline No
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