search
Back to results

Effects of Home Based Resistance Training as Compared to Supervised Resistance Training Exercise in the Management of Osteoarthritis.

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
resistance exercise
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis, Knee

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foundation University College of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A (Resistant Training)

Group B (Home Based resistant training)

Arm Description

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.

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 .

Outcomes

Primary Outcome Measures

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
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
Muscle strength
measured by using Modified Sphygmomanometer Dynamometry
Gait Cadence
Cadence (steps/min) = steps counted x 60/time (s)
Range of motion
Description measured by using Goniometer
Gait Stride length
Stride length (m) = speed (m/s) x cycle time (s)
Gait Speed
Gait Speed (m/s) = distance (m) / time (s)

Secondary Outcome Measures

Full Information

First Posted
September 13, 2023
Last Updated
October 6, 2023
Sponsor
Foundation University Islamabad
search

1. Study Identification

Unique Protocol Identification Number
NCT06076278
Brief Title
Effects of Home Based Resistance Training as Compared to Supervised Resistance Training Exercise in the Management of Osteoarthritis.
Official Title
Effects of Home Based Resistance Training as Compared to Supervised Resistance Training Exercise in the Management of Osteoarthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Resistant Training)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B (Home Based resistant training)
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Procedure
Intervention Name(s)
resistance exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain severity
Description
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
Time Frame
4 week
Title
Disability level of participant
Description
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
Time Frame
4 weeks
Title
Muscle strength
Description
measured by using Modified Sphygmomanometer Dynamometry
Time Frame
4 weeks
Title
Gait Cadence
Description
Cadence (steps/min) = steps counted x 60/time (s)
Time Frame
4 weeks
Title
Range of motion
Description
Description measured by using Goniometer
Time Frame
4 weeks
Title
Gait Stride length
Description
Stride length (m) = speed (m/s) x cycle time (s)
Time Frame
4 weeks
Title
Gait Speed
Description
Gait Speed (m/s) = distance (m) / time (s)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdullah Khan, MS-MSKPT*
Phone
03160906437
Email
abdullahkhan3402318843@gmail.com
Facility Information:
Facility Name
Foundation University College of Physical Therapy
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Saqeef, MS
Phone
03125039513
Email
Saqeef@fui.du.pk

12. IPD Sharing Statement

Learn more about this trial

Effects of Home Based Resistance Training as Compared to Supervised Resistance Training Exercise in the Management of Osteoarthritis.

We'll reach out to this number within 24 hrs