- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06444932
SUPPLEMENTARY EFFECTS OF RESISTANCE TRAINING IN ADDITION TO JOINT MOBILIZATION IN PERSONS WITH KNEE OSTEOARTHRITIS
June 5, 2024 updated by: Foundation University Islamabad
Joint mobilization and resistance exercise training are effective conservative treatment options for the management of osteoarthritis.
However, currently no study has highlighted the supplementary effects of resistance training in addition to joint mobilization in people suffering from knee osteoarthritis.
The current study is aimed at bridging the gap in literature and providing evidence regarding the additive impact of resistance training to joint mobilization in knee osteoarthritis.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Interventional
Enrollment (Estimated)
44
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
-
-
-
Islamabad, Pakistan
- Foundation Univeristy Islamabad
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Knee OA grade I-III
- Individuals of either gender aged 40-70 years
- Knee OA history of no less than 3 months
- Knee pain no more than 8/10 cm on the visual analogue scale (VAS)
- Radiological evidence of grade III or less on Kellgren classification.
Exclusion Criteria:
- Those with signs of serious pathology such as malignancy, inflammatory disorder or infection.
- History of trauma or fractures in lower extremity
- Signs of lumbar radiculopathy or myelopathy
- History of knee surgery or replacement and/or receiving intra-articular steroid therapy in the preceding two months
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
|
Patellofemoral and tibiofemoral joint mobilization
Transcutaneous Electric Nerve Stimulation (TENS)
Heating pad for heat therapy
Lower limb resistance exercise training
|
|
Active Comparator: Active Comparator
|
Patellofemoral and tibiofemoral joint mobilization
Transcutaneous Electric Nerve Stimulation (TENS)
Heating pad for heat therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walking related performance fatigability
Time Frame: 4 weeks
|
Walking related performance fatigability will be measured using 6 minute walk test.
Greater fatigability indicates poorer outcome.
|
4 weeks
|
|
Stride Length
Time Frame: 4 weeks
|
Gait analysis will be done to analyze stride length.
A greater stride length signifies positive outcome and prognosis.
|
4 weeks
|
|
Gait velocity
Time Frame: 4 weeks
|
Gait analysis will be done to analyze gaot velocity.
A greater gait velocity signifies positive outcome and prognosis.
|
4 weeks
|
|
Knee Pain
Time Frame: 4 weeks
|
Knee Pain will be measured using visual analogue scale (VAS) from 0-100mm.
A higher score on VAS indicated greater pain.
|
4 weeks
|
|
Knee range of motion
Time Frame: 4 weeks
|
Knee range of motion will be measured using a goniometer.
A higher ROM signifies positive outcome.
|
4 weeks
|
|
Functional Disability
Time Frame: 4 weeks
|
Knee functional disability will be assessed using Knee Osteoarthritis and Outcome Score (KOOS) with a score ranging from 0-100.
A lower score on KOOS signifies greater functional disability.
|
4 weeks
|
|
Isometric Muscle Strength
Time Frame: 4 weeks
|
Isometric Muscle Strength will be quantified using dynamometer.
A higher score on dynamometer signifies greater muscle strength and good prognosis.
|
4 weeks
|
|
Functional capacity
Time Frame: 4 weeks
|
5 repetition sit to stand test will be used to determine knee related functional capacity, which will be quantified in terms of time.
A smaller time will denote greater functional capacity.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muhammad Osama, PhD*, Foundation University Islamabad
- Principal Investigator: Wania Maheen, DPT, Foundation University Islamabad
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 (Estimated)
June 10, 2024
Primary Completion (Estimated)
December 10, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
May 27, 2024
First Submitted That Met QC Criteria
June 5, 2024
First Posted (Actual)
June 6, 2024
Study Record Updates
Last Update Posted (Actual)
June 6, 2024
Last Update Submitted That Met QC Criteria
June 5, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2024/12
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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