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

NCT ID: NCT04530266

Last Updated: 2020-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-28

Study Completion Date

2020-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Persons with knee osteoarthritis

Group Type ACTIVE_COMPARATOR

Six minute walk test

Intervention Type DIAGNOSTIC_TEST

Assessment of walking related performance fatigability using six minute walk test

Healthy controls

Group Type PLACEBO_COMPARATOR

Six minute walk test

Intervention Type DIAGNOSTIC_TEST

Assessment of walking related performance fatigability using six minute walk test

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Six minute walk test

Assessment of walking related performance fatigability using six minute walk test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hasselt University

OTHER

Sponsor Role collaborator

Foundation University Islamabad

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Muhammad Osama, PhD*

Role: PRINCIPAL_INVESTIGATOR

Foundation University Islamabad

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Foundation University Institute of Rehabilitation Sciences.

Islamabad, Federal, Pakistan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Muhammad Osama, PhD*

Role: CONTACT

03325540436

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Muhammad Osama, PhD*

Role: primary

03325540436

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FUI/CTR/2020/6

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.