Knee OsteoarthritisNCT06444932
SUPPLEMENTARY EFFECTS OF RESISTANCE TRAINING IN ADDITION TO JOINT MOBILIZATION IN PERSONS WITH KNEE OSTEOARTHRITIS
A study testing Joint Mobilization, Resistance Exercise Training and Transcutaneous Electric Nerve Stimulation (TENS) in people with Knee Osteoarthritis, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Joint Mobilization, Resistance Exercise Training and Transcutaneous Electric Nerve Stimulation (TENS)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2024to 30 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Joint Mobilization, Resistance Exercise Training, Transcutaneous Electric Nerve Stimulation (TENS), Heating Pad
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint MobilizationProcedure or surgery
Patellofemoral and tibiofemoral joint mobilization
Resistance Exercise TrainingProcedure or surgery
Lower limb resistance exercise training
Transcutaneous Electric Nerve Stimulation (TENS)Device
Transcutaneous Electric Nerve Stimulation (TENS)
Heating PadDevice
Heating pad for heat therapy
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Not described Receives: Procedure: Joint Mobilization; Device: Transcutaneous Electric Nerve Stimulation (TENS); Device: Heating Pad |
| Experimental Group | Experimental | Not described Receives: Procedure: Joint Mobilization; Procedure: Resistance Exercise Training; Device: Transcutaneous Electric Nerve Stimulation (TENS); Device: Heating Pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking related performance fatigability
Walking related performance fatigability will be measured using 6 minute walk test. Greater fatigability indicates poorer outcome.
Measured: 4 weeks
Stride Length
Gait analysis will be done to analyze stride length. A greater stride length signifies positive outcome and prognosis.
Measured: 4 weeks
Gait velocity
Gait analysis will be done to analyze gaot velocity. A greater gait velocity signifies positive outcome and prognosis.
Measured: 4 weeks
Knee Pain
Knee Pain will be measured using visual analogue scale (VAS) from 0-100mm. A higher score on VAS indicated greater pain.
Measured: 4 weeks
Knee range of motion
Knee range of motion will be measured using a goniometer. A higher ROM signifies positive outcome.
Measured: 4 weeks
Functional Disability
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.
Measured: 4 weeks
Isometric Muscle Strength
Isometric Muscle Strength will be quantified using dynamometer. A higher score on dynamometer signifies greater muscle strength and good prognosis.
Measured: 4 weeks
Functional capacity
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start10 Jun 2024 (estimated)
- Primary completion10 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double arm parallel design RCT
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wania Maheen, DPT, Principal investigator, Foundation University IslamabadMuhammad Osama, PhD*, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444932
- Sponsor's protocol ID
- FUI/CTR/2024/12
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 6 Jun 2024
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUPPLEMENTARY EFFECTS OF RESISTANCE TRAINING IN ADDITION TO JOINT MOBILIZATION IN PERSONS WITH KNEE OSTEOARTHRITIS
- ClinicalTrials.gov ID
- NCT06444932
- Acronym / sponsor ID
- FUI/CTR/2024/12
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Jun 2024 (estimated)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 6 Jun 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Double arm parallel design RCT
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Procedure: Joint Mobilization, Device: Transcutaneous Electric Nerve Stimulation (TENS), Device: Heating Pad |
| Experimental Group | Experimental | Procedure: Joint Mobilization, Procedure: Resistance Exercise Training, Device: Transcutaneous Electric Nerve Stimulation (TENS), Device: Heating Pad |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Joint MobilizationPatellofemoral and tibiofemoral joint mobilization | Procedure or surgery | Active Comparator, Experimental Group |
| Resistance Exercise TrainingLower limb resistance exercise training | Procedure or surgery | Experimental Group |
| Transcutaneous Electric Nerve Stimulation (TENS)Transcutaneous Electric Nerve Stimulation (TENS) | Device | Active Comparator, Experimental Group |
| Heating PadHeating pad for heat therapy | Device | Active Comparator, Experimental Group |
Primary outcome
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.
Stride Length
Time frame: 4 weeks
Gait analysis will be done to analyze stride length. A greater stride length signifies positive outcome and prognosis.
Gait velocity
Time frame: 4 weeks
Gait analysis will be done to analyze gaot velocity. A greater gait velocity signifies positive outcome and prognosis.
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.
Knee range of motion
Time frame: 4 weeks
Knee range of motion will be measured using a goniometer. A higher ROM signifies positive outcome.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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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.
Wania Maheen, DPT principal investigator
Foundation University Islamabad
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 Joint Mobilization, Resistance Exercise Training and Transcutaneous Electric Nerve Stimulation (TENS) in people with Knee Osteoarthritis, 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 5 inclusion and 4 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 6 Jun 2024. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking related performance fatigability (time frame: 4 weeks). The study lists 8 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 6 Jun 2024.