Reliability of Measuring Walking-related Performance Fatigability Using Six Minute Walk Test in Persons With Knee Osteoarthritis

August 27, 2020 updated by: Foundation University Islamabad
Evidence has shown that knee osteoarthritis causes an increase in base of support and a decrease in stride length and gait velocity which results in an increase in energy expenditure during walking. This increase in energy cost of walking is suggested to result in walking related performance fatigability. However, fatigue is not commonly considered in the clinical settings in term of neither assessment nor management of knee osteoarthritis. One common tool used to evaluate walking relate performance is six minute walk test and the purpose of this study is to determine the reliability of using six minute walk test to determine walking related performance fatigability in persons with knee osteoarthritis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 46000
        • Recruiting
        • Foundation University Institute of Rehabilitation Sciences.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 40-70 years
  • Knee OA with history not less than three months.
  • Radiological evidences of grade III or less on Kellgren classification.
  • Knee pain on VNRS no more than 8/10.

Exclusion Criteria:

  • Neuromuscular conditions that may lead to fatigue such as multiple Sclerosis
  • Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection).
  • History of trauma or fractures in lower extremity.
  • Signs of lumbar radiculopathy or myelopathy.
  • History of knee surgery or replacement.
  • Patients on intra-articular steroid therapy within two months before the commencement of the study.
  • Impaired skin sensation and renal function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Persons with knee osteoarthritis
Diagnostic test: Six minute walk test
Assessment of walking related performance fatigability using six minute walk test
PLACEBO_COMPARATOR: Healthy controls
Diagnostic test: Six minute walk test
Assessment of walking related performance fatigability using six minute walk test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of walking related performance fatigability using six minute walk test
Time Frame: Day 1
Day 1
Assessment of walking related performance fatigability using six minute walk test
Time Frame: Day 2
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation University Islamabad

Collaborators

Hasselt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 28, 2020

Primary Completion (ANTICIPATED)

December 28, 2020

Study Completion (ANTICIPATED)

December 28, 2020

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (ACTUAL)

August 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 27, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUI/CTR/2020/6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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