Osteoarthritis, KneeNCT06076278
Effects of Home Based Resistance Training as Compared to Supervised Resistance Training Exercise in the Management of Osteoarthritis.
A study testing resistance exercise in people with Osteoarthritis, Knee, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Knee osteoarthritis is a degenerative pathology that is characterized by structural changes in the joint, such as joint space narrowing, thickening of the joint capsule, and cartilage degeneration that encourages friction between the bone surfaces and causes pain, which is thought to be a major symptom of knee… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- resistance exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2023to 1 Feb 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 25 to 60 years experiencing knee pain.
- Both male and female.
- Patients with grade 1 to 3 OA based on Kellgren Lawrence classification of knee OA.
- Those participants with 4-8 on NPRS
Who cannot join
- Individuals with serious pathology such as malignancy, inflammatory disorder or infection.
- Individual with history of knee surgery or replacement.
- Those patients who have received physiotherapy from last 2 months.
- Those patients who have received any surgical treatment for SIJ dysfunction
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Muhammad Saqeef, MS, 03125039513, Saqeef@fui.du.pk
About this study
Knee osteoarthritis is a degenerative pathology that is characterized by structural changes in the joint, such as joint space narrowing, thickening of the joint capsule, and cartilage degeneration that encourages friction between the bone surfaces and causes pain, which is thought to be a major symptom of knee osteoarthritis. Knee osteoarthritis (OA) treatment focuses on reducing pain while also enhancing function and quality of life by resistant training and Home-based exercise, a time-effective and practical treatment option for people with chronic conditions. As the past literature states that home based trainings are cost and time effective, However there is deficient evidence regarding effectiveness of home based strength training in case of knee osteoarthritis. More evidence is therefore needed in this regard.
Read the detailed description
As the investigators know knee osteoarthritis (KOA) is common in elderly people, causes pain, loss of physical functioning, and disability. Knee osteoarthritis (OA) treatment focuses on reducing pain while also enhancing function and quality of life. Increased interest in non-pharmacologic treatments for OA is a result of declining enthusiasm for cyclooxygenase-2 inhibitors as a means of treating knee OA pain and failing clinical trials of OA medications that aim to change the illness. The two hallmarks of non-pharmacologic treatment are resistance training (RT) exercise programs and educational self-management (SM) programs and It has been evident in recent years that RT can have a favorable impact on activity-related energy expenditure, total free-living energy expenditure, and resting energy expenditure (REE) (AEE).Home based training; Home-based exercise, a time-effective and practical treatment option for people with chronic conditions like KOA, is becoming more valued by rehabilitation professionals and researchers. It can performed by patients individually at home, The goal of home-based and hospital-based exercise is the same; that is, to relieve pain and improve function by strengthening lower limb muscles, improving neuromuscular control, and range of joint motion in the affected knees. The main aim of the study is to determine the effectiveness of home-based resistance training as compared to supervised resistance training exercises in the management of knee osteoarthritis in terms of pain, ROM , disability, muscle strength and spatiotemporal parameter of gait. The participants meeting the eligibility criteria will be recruited, followed by random allocation to 2 groups. Both groups will receive standard treatment protocol which consists resistant training .12 sessions will be provided on alternative days. Pre and Post assessment of will be noted .
- Conditions
- Osteoarthritis, Knee
- Being tested
- resistance exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance exerciseProcedure or surgery
Isometrics contraction of quadriceps Supine straight leg raise Leg lifts in prone position Passive knee flexion Passive knee extension Resistance knee extension Resistance knee flexion Isometric terminal knee extension in lying and mini-squat Concentric and isometric knee extension and flexion in sitting Frequency: A total of 12 sessions, thrice a week, for 4 consecutive weeks. Time Duration: Approx. 25 to 30minutes
| Study group | Role | What they receive |
|---|---|---|
| Group A (Resistant Training) | Active comparator | Patients in this group will recieve Clinic based resistant training . A total of 12 sessions will be conducted over a period of 4 week 3 days a week. Receives: Procedure: resistance exercise |
| Group B (Home Based resistant training) | Experimental | Patients will recieve home based resistant training. A total of 12 sessions will be conducted over a period of 4 week ,3 days a week . Receives: Procedure: resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
Pain will be measured using the Numeric Pain Rating Scale, which is an 11-item scale.The higher the score the greater will be pain severity
Measured: 4 week
Disability level of participant
Disability will be assessed using Western Ontario and McMaster University Osteoarthritis Index. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations
Measured: 4 weeks
Muscle strength
measured by using Modified Sphygmomanometer Dynamometry
Measured: 4 weeks
Gait Cadence
Cadence (steps/min) = steps counted x 60/time (s)
Measured: 4 weeks
Range of motion
Description measured by using Goniometer
Measured: 4 weeks
Gait Stride length
Stride length (m) = speed (m/s) x cycle time (s)
Measured: 4 weeks
Gait Speed
Gait Speed (m/s) = distance (m) / time (s)
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 posted10 Oct 2023
- Study start30 Aug 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial having two groups. One group will receive home based resistant training and the second will receive clinic based resistant training. Both groups will be recruited concurrently.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076278
- Sponsor's protocol ID
- FUI/CTR/2023/17
- Status last verified
- Oct 2023
- First submitted
- 13 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home Based Resistance Training as Compared to Supervised Resistance Training Exercise in the Management of Osteoarthritis.
- ClinicalTrials.gov ID
- NCT06076278
- Acronym / sponsor ID
- FUI/CTR/2023/17
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 10 Oct 2023 (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.
Knee osteoarthritis is a degenerative pathology that is characterized by structural changes in the joint, such as joint space narrowing, thickening of the joint capsule, and cartilage degeneration that encourages friction between the bone surfaces and causes pain, which is thought to be a major symptom of knee osteoarthritis. Knee osteoarthritis (OA) treatment focuses on reducing pain while also enhancing function and quality of life by resistant training and Home-based exercise, a time-effective and practical treatment option for people with chronic conditions. As the past literature states that home based trainings are cost and time effective, However there is deficient evidence regarding effectiveness of home based strength training in case of knee osteoarthritis. More evidence is therefore needed in this regard.
Detailed description
As the investigators know knee osteoarthritis (KOA) is common in elderly people, causes pain, loss of physical functioning, and disability. Knee osteoarthritis (OA) treatment focuses on reducing pain while also enhancing function and quality of life. Increased interest in non-pharmacologic treatments for OA is a result of declining enthusiasm for cyclooxygenase-2 inhibitors as a means of treating knee OA pain and failing clinical trials of OA medications that aim to change the illness. The two hallmarks of non-pharmacologic treatment are resistance training (RT) exercise programs and educational self-management (SM) programs and It has been evident in recent years that RT can have a favorable impact on activity-related energy expenditure, total free-living energy expenditure, and resting energy expenditure (REE) (AEE).Home based training; Home-based exercise, a time-effective and practical treatment option for people with chronic conditions like KOA, is becoming more valued by rehabilitation professionals and researchers. It can performed by patients individually at home, The goal of home-based and hospital-based exercise is the same; that is, to relieve pain and improve function by strengthening lower limb muscles, improving neuromuscular control, and range of joint motion in the affected knees. The main aim of the study is to determine the effectiveness of home-based resistance training as compared to supervised resistance training exercises in the management of knee osteoarthritis in terms of pain, ROM , disability, muscle strength and spatiotemporal parameter of gait. The participants meeting the eligibility criteria will be recruited, followed by random allocation to 2 groups. Both groups will receive standard treatment protocol which consists resistant training .12 sessions will be provided on alternative days. Pre and Post assessment of will be noted .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial having two groups. One group will receive home based resistant training and the second will receive clinic based resistant training. Both groups will be recruited concurrently.
| Arm | Type | Receives |
|---|---|---|
| Group A (Resistant Training) | Active comparator | Procedure: resistance exercisePatients in this group will recieve Clinic based resistant training . A total of 12 sessions will be conducted over a period of 4 week 3 days a week. |
| Group B (Home Based resistant training) | Experimental | Procedure: resistance exercisePatients will recieve home based resistant training. A total of 12 sessions will be conducted over a period of 4 week ,3 days a week . |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 25 to 60 years experiencing knee pain.
- Both male and female.
- Patients with grade 1 to 3 OA based on Kellgren Lawrence classification of knee OA.
- Those participants with 4-8 on NPRS
Key exclusion criteria (4 listed)
- Individuals with serious pathology such as malignancy, inflammatory disorder or infection.
- Individual with history of knee surgery or replacement.
- Those patients who have received physiotherapy from last 2 months.
- Those patients who have received any surgical treatment for SIJ dysfunction
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 |
|---|---|---|
| resistance exerciseIsometrics contraction of quadriceps Supine straight leg raise Leg lifts in prone position Passive knee flexion Passive knee extension Resistance knee extension Resistance knee flexion Isometric terminal knee extension in lying and mini-squat Concentric and isometric knee extension and flexion in sitting Frequency: A total of 12 sessions, thrice a week, for 4 consecutive weeks. Time Duration: Approx. 25 to 30minutes | Procedure or surgery | Group A (Resistant Training), Group B (Home Based resistant training) |
Primary outcome
Pain severity
Time frame: 4 week
Pain will be measured using the Numeric Pain Rating Scale, which is an 11-item scale.The higher the score the greater will be pain severity
Disability level of participant
Time frame: 4 weeks
Disability will be assessed using Western Ontario and McMaster University Osteoarthritis Index. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations
Muscle strength
Time frame: 4 weeks
measured by using Modified Sphygmomanometer Dynamometry
Gait Cadence
Time frame: 4 weeks
Cadence (steps/min) = steps counted x 60/time (s)
Range of motion
Time frame: 4 weeks
Description measured by using Goniometer
Gait Stride length
Time frame: 4 weeks
Stride length (m) = speed (m/s) x cycle time (s)
Gait Speed
Time frame: 4 weeks
Gait Speed (m/s) = distance (m) / time (s)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistance exercise in people with 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 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 10 Oct 2023. 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?
Contact Abdullah Khan, MS-MSKPT* (03160906437, abdullahkhan3402318843@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity (time frame: 4 week). The study lists 7 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 10 Oct 2023.