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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03123757
Other study ID # Mobility and Quality of Life
Secondary ID
Status Completed
Phase N/A
First received April 11, 2017
Last updated April 17, 2017
Start date April 1, 2015
Est. completion date August 31, 2015

Study information

Verified date April 2017
Source Precision Health Economics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the determinants of mobility, measured by the 6-minute walk test, and its correlation with quality of life in near elderly patients.


Description:

To evaluate the determinants of mobility an its correlation with quality of life, we conducted a study that evaluated patients ability to perform the 6-minute walk test and their corresponding quality of life measured by the EQ-5D. Cognition was evaluated used the Callahan six-item screener, and additional measures of physical performance were assessed using the Short Physical Performance Battery. Participants disclosed self reported physical function and physical activity. Additionally, other participant characteristics including vital signs, medication history and healthcare utilization were determined as well as social, economic and health related information was collected.


Recruitment information / eligibility

Status Completed
Enrollment 207
Est. completion date August 31, 2015
Est. primary completion date August 31, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria:

- Willing to provide informed consent

- Willing to perform the 6-minute walk without the use of a walker, or the assistance of another person.

- Ability to speak and understand English

Exclusion Criteria:

- Medical condition that precludes safe participation in the 6 minute walk test

Study Design


Related Conditions & MeSH terms


Intervention

Other:
6 Minute Walk Test
The 6 minute walk test measures the distance walked in 6 minutes without sitting and without the use of a walker or the help of another person (a cane may be used). The walk was conducted in a wide hallway, specifically designed for this type of assessment, with a defined 20-meter course. The subject walked back and forth in the hallway for six minutes and the distance covered was recorded.
EQ-5D Survey
The EQ-5D is a self-reported questionnaire that describes a respondent's health using a descriptive system comprised of five items, each representing a different health dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, respondents state whether they have no problems, slight problems, moderate problems, severe problems, or are unable to perform the activity.
Short Physical Performance Battery
The SPPB is a brief performance battery based on timed short distance walk, repeated chair stands and balance test administered by trained examiners. The measurement goal for this battery is to assess lower extremity functional limitations, which indicate functional abilities and are a strong measure of risk for future disability.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Precision Health Economics Sanofi

Outcome

Type Measure Description Time frame Safety issue
Primary Patient-Reported Quality of Life Measured using the EQ-5D instrument On the day of assessment
Secondary Mobility Measured using the 6-minute walk test On the day of assessment
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