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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06076278
Other study ID # FUI/CTR/2023/17
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 30, 2023
Est. completion date February 1, 2024

Study information

Verified date October 2023
Source Foundation University Islamabad
Contact Abdullah Khan, MS-MSKPT*
Phone 03160906437
Email abdullahkhan3402318843@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date February 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 25 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
resistance exercise
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

Locations

Country Name City State
Pakistan Foundation University College of Physical Therapy Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 4 week
Primary 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 4 weeks
Primary Muscle strength measured by using Modified Sphygmomanometer Dynamometry 4 weeks
Primary Gait Cadence Cadence (steps/min) = steps counted x 60/time (s) 4 weeks
Primary Range of motion Description measured by using Goniometer 4 weeks
Primary Gait Stride length Stride length (m) = speed (m/s) x cycle time (s) 4 weeks
Primary Gait Speed Gait Speed (m/s) = distance (m) / time (s) 4 weeks
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