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

NCT ID: NCT03123757

Last Updated: 2017-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2015-08-31

Brief 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.

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.

Conditions

Aged

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: OTHER

6 Minute Walk Test

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

SPPB

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Precision Health Economics

OTHER

Sponsor Role: lead

Responsible Party

Jason Shafrin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Shafrin, PhD

Role: PRINCIPAL_INVESTIGATOR

Precision Health Economics

Other Identifiers

Mobility and Quality of Life

Identifier Type: -

Identifier Source: org_study_id