NCT03123757

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

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

April 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

April 11, 2017

Last Update Submit

April 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient-Reported Quality of Life

    Measured using the EQ-5D instrument

    On the day of assessment

Secondary Outcomes (1)

  • Mobility

    On the day of assessment

Study Arms (1)

Intervention

OTHER

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

Other: 6 Minute Walk TestOther: EQ-5D SurveyOther: Short Physical Performance Battery

Interventions

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

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

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.

Also known as: SPPB
Intervention

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jason Shafrin, PhD

    Precision Health Economics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All subjects enrolled in our trial performed the 6-minute walk test and completed an EQ-5D quality of life questionnaire.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 21, 2017

Study Start

April 1, 2015

Primary Completion

August 31, 2015

Study Completion

August 31, 2015

Last Updated

April 21, 2017

Record last verified: 2017-04