OsteoarthritisNCT04530266
Reliability of Measuring Walking-related Performance Fatigability Using Six Minute Walk Test in Persons With Knee Osteoarthritis
A study testing Six minute walk test in people with Osteoarthritis and Osteoarthritis, Knee, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Osteoarthritis, Knee
- What is being tested?
- Six minute walk test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Aug 2020to 28 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University Institute of Rehabilitation Sciences.
Islamabad, Federal, 46000
Muhammad Osama, PhD*, 03325540436, osamadpt@gmail.com
About this study
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
- Being tested
- Six minute walk test
- Keywords
- osteoarthritis, six minute walk test, reliability, fatigue, fatigability
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six minute walk testDiagnostic test
Assessment of walking related performance fatigability using six minute walk test
| Study group | Role | What they receive |
|---|---|---|
| Persons with knee osteoarthritis | Active comparator | Not described Receives: Diagnostic Test: Six minute walk test |
| Healthy controls | Placebo comparator | Not described Receives: Diagnostic Test: Six minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of walking related performance fatigability using six minute walk test
Measured: Day 1
Assessment of walking related performance fatigability using six minute walk test
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start28 Aug 2020 (estimated)
- Primary completion28 Dec 2020 (estimated)
- Study completion28 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Collaborators
- Hasselt University
- Responsible party
- Sponsor
- Investigators
- Muhammad Osama, PhD*, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530266
- Sponsor's protocol ID
- FUI/CTR/2020/6
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Measuring Walking-related Performance Fatigability Using Six Minute Walk Test in Persons With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04530266
- Acronym / sponsor ID
- FUI/CTR/2020/6
- Conditions
- Osteoarthritis, Osteoarthritis, Knee
- Keywords
- osteoarthritis, six minute walk test, reliability, fatigue, fatigability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Collaborators
- Hasselt University
- Study start
- 28 Aug 2020 (estimated)
- Primary completion
- 28 Dec 2020 (estimated)
- Study completion
- 28 Dec 2020 (estimated)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persons with knee osteoarthritis | Active comparator | Diagnostic Test: Six minute walk test |
| Healthy controls | Placebo comparator | Diagnostic Test: Six minute walk test |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six minute walk testAssessment of walking related performance fatigability using six minute walk test | Diagnostic test | Healthy controls, Persons with knee osteoarthritis |
Primary outcome
Assessment of walking related performance fatigability using six minute walk test
Time frame: Day 1
Assessment of walking related performance fatigability using six minute walk test
Time frame: Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Osama, PhD* principal investigator
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Six minute walk test in people with Osteoarthritis and Osteoarthritis, Knee, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Osama, PhD* (03325540436, osamadpt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of walking related performance fatigability using six minute walk test (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.