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

Primary Purpose

Osteoarthritis, Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Six minute walk test
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteoarthritis focused on measuring osteoarthritis, six minute walk test, reliability, fatigue, fatigability

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Foundation University Institute of Rehabilitation Sciences.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Persons with knee osteoarthritis

Healthy controls

Arm Description

Outcomes

Primary Outcome Measures

Assessment of walking related performance fatigability using six minute walk test
Assessment of walking related performance fatigability using six minute walk test

Secondary Outcome Measures

Full Information

First Posted
August 25, 2020
Last Updated
August 27, 2020
Sponsor
Foundation University Islamabad
Collaborators
Hasselt University
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1. Study Identification

Unique Protocol Identification Number
NCT04530266
Brief Title
Reliability of Measuring Walking-related Performance Fatigability Using Six Minute Walk Test in Persons With Knee Osteoarthritis
Official Title
Reliability of Measuring Walking-related Performance Fatigability Using Six Minute Walk Test in Persons With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 28, 2020 (Anticipated)
Primary Completion Date
December 28, 2020 (Anticipated)
Study Completion Date
December 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad
Collaborators
Hasselt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Osteoarthritis, Knee
Keywords
osteoarthritis, six minute walk test, reliability, fatigue, fatigability

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Persons with knee osteoarthritis
Arm Type
Active Comparator
Arm Title
Healthy controls
Arm Type
Placebo Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Six minute walk test
Intervention Description
Assessment of walking related performance fatigability using six minute walk test
Primary Outcome Measure Information:
Title
Assessment of walking related performance fatigability using six minute walk test
Time Frame
Day 1
Title
Assessment of walking related performance fatigability using six minute walk test
Time Frame
Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Osama, PhD*
Phone
03325540436
Email
osamadpt@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Osama, PhD*
Organizational Affiliation
Foundation University Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foundation University Institute of Rehabilitation Sciences.
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Osama, PhD*
Phone
03325540436
Email
osamadpt@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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