- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06076278
Effects of Home Based Resistance Training as Compared to Supervised Resistance Training Exercise in the Management of Osteoarthritis.
October 6, 2023 updated by: Foundation University Islamabad
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
34
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 Contact
- Name: Abdullah Khan, MS-MSKPT*
- Phone Number: 03160906437
- Email: abdullahkhan3402318843@gmail.com
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Recruiting
- Foundation University College of Physical Therapy
-
Contact:
- Muhammad Saqeef, MS
- Phone Number: 03125039513
- Email: Saqeef@fui.du.pk
-
-
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:
- 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
Exclusion Criteria:
- 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
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A (Resistant Training)
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.
|
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
|
|
Experimental: Group B (Home Based resistant training)
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 .
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
4 week
|
|
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
|
4 weeks
|
|
Muscle strength
Time Frame: 4 weeks
|
measured by using Modified Sphygmomanometer Dynamometry
|
4 weeks
|
|
Gait Cadence
Time Frame: 4 weeks
|
Cadence (steps/min) = steps counted x 60/time (s)
|
4 weeks
|
|
Range of motion
Time Frame: 4 weeks
|
Description measured by using Goniometer
|
4 weeks
|
|
Gait Stride length
Time Frame: 4 weeks
|
Stride length (m) = speed (m/s) x cycle time (s)
|
4 weeks
|
|
Gait Speed
Time Frame: 4 weeks
|
Gait Speed (m/s) = distance (m) / time (s)
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
August 30, 2023
Primary Completion (Estimated)
January 1, 2024
Study Completion (Estimated)
February 1, 2024
Study Registration Dates
First Submitted
September 13, 2023
First Submitted That Met QC Criteria
October 6, 2023
First Posted (Actual)
October 10, 2023
Study Record Updates
Last Update Posted (Actual)
October 10, 2023
Last Update Submitted That Met QC Criteria
October 6, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2023/17
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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