Assessing the Determinants of 6-minute Walk Test and Its Correlation With Quality of Life

Assessing the Determinants of 6-minute Walk Test and Its Correlation With Quality of Life: A Survey of Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Aged
• Intervention / Treatment: Other: 6 Minute Walk Test; Other: EQ-5D Survey; Other: Short Physical Performance Battery

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Intervention; Patients performed the 6-minute walk test and completed the EQ-5D quality of life questionnaire.

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.; Other: 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.; Other: 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.; Other Names: SPPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Quality of Life	Measured using the EQ-5D instrument	On the day of assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobility	Measured using the 6-minute walk test	On the day of assessment

Collaborators and Investigators

• Sponsor: Precision Health Economics
• Collaborators: Sanofi
• Investigators: Principal Investigator: Jason Shafrin, PhD, Precision Health Economics

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): August 31, 2015
• Study Completion (Actual): August 31, 2015

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Mobility and Quality of Life

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No