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

NCT04530266 | Unknown

• 1 other identifier: FUI/CTR/2020/6
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Osteoarthritis, Knee

Keywords

osteoarthritis; six minute walk test; reliability; fatigue; fatigability

Outcome Measures

Primary Outcomes (2)

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

  Day 1

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

  Day 2

Study Arms (2)

Persons with knee osteoarthritis

ACTIVE COMPARATOR

Diagnostic Test: Six minute walk test

Healthy controls

PLACEBO COMPARATOR

Diagnostic Test: Six minute walk test

Interventions

Six minute walk test DIAGNOSTIC_TEST

Assessment of walking related performance fatigability using six minute walk test

Healthy controls; Persons with knee osteoarthritis

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation University Islamabad: lead
• Hasselt University: collaborator

Study Sites (1)

Foundation University Institute of Rehabilitation Sciences.

Islamabad, Federal, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Fatigue

Interventions

Walk Test

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Muhammad Osama, PhD*

  Foundation University Islamabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Osama, PhD*

CONTACT

03325540436; osamadpt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: August 28, 2020
• Primary Completion: December 28, 2020
• Study Completion: December 28, 2020
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)