NCT01768754

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2013

Enrollment Period

7 months

First QC Date

January 9, 2013

Last Update Submit

March 8, 2013

Conditions

Keywords

Exercise testingFunctional statusPulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • Agreement in walk speeds between optical sensors and stopwatch

    Baseline and over 1 week of testing.

  • Agreement in the Bode Index using six minute walk distance and usual walk speed.

    Baseline

Other Outcomes (1)

  • Precision of achieving a targeted endurance time using the usual and fast walking speeds.

    Baseline

Study Arms (1)

COPD patients

Usual and Fast Walking Speeds

Behavioral: Usual and Fast Walking Speeds

Interventions

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.

COPD patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Clinical and spirometric diagnosis of COPD
  • Able to provide written informed consent

You may not qualify if:

  • Unstable cardiovascular disease
  • Acute respiratory exacerbation within 4 weeks
  • Neurologic or orthopedic limitation to walking
  • Inability to comprehend instructions in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westpark Health Care Centre

Toronto, Ontario, M6M 2J5, Canada

Location

Related Publications (1)

  • Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. doi: 10.1177/096228029900800204.

    PMID: 10501650BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roger Goldstein, MD, FRCPC

    Westpark Healthcare Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Respiratory Medicine

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 15, 2013

Study Start

July 1, 2012

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

March 12, 2013

Record last verified: 2013-03

Locations