- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06377813
Combined Mode-Kinetic Chain Exercise With and Without Core Stability Exercises on Patients With Knee Osteoarthritis
Effect of Combined Mode-Kinetic Chain Exercise With and Without Core Stability Exercises on Pain, Range of Motion, Quality of Life on Patients With Knee Osteoarthritis
The goal of this [type of study: Randomized control trial] is to [ see the effects of Combined Mode Kinetic Chain Exercises along with or without core stability exercises on pain, range of motion and disability ] in [ in patients with Knee Osteoarthritis].The main question it aims to answer is:
Wether core stability exercises is effective if performed along with Combined chain kinetic exercises to improves the condition of Knee Osteoarthritis? Group A will receive Core Stability Exercises along with Combined Chain Kinetic Exercises and Group B will receive combined Chain Kinetic Exercises.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Knee joint Osteoarthritis is a prevalent and multifaceted condition, affecting a substantial portion of the general population (roughly 13% of women and 10% of men 60 years). Different techniques and treatment methods have been used to treat knee osteoarthritis. In this study, I will be identifying that core stability exercise if performed along with Combined chain kinetic exercise brings benefits to the patients of knee osteoarthritis. One of the techniques is Combined Chain Kinetic Exercise that i will be applying on both groups. The other one is the set of Core stability exercises.
The research involves two intervention groups (Group A and Group B) receiving specific treatments over 60 sessions within an twelve-week period. Group A incorporates the Combined Chain Kinetic Exercise,Core stability exercises, and transcutaneous electrical nerve stimulation (TENS) with a heating pad. Group B undergoes hot packs and TENS, followed by Combined Chain Kinetic Exercise, encompassing pain levels, range of motion (ROM), and Knee Injury and Osteoarthritis Outcome Score (KOOS) scores, will be evaluated using the Numeric Pain Rating Scale, Goniometer, and KOOS. Data analysis will employ SPSS version 26. Data will be collected at baseline, immediately post-intervention, and at follow-up intervals.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Riphah International University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 40 to 70 years with Knee Osteoarthritis
Exclusion Criteria:
- Participants suffering from any other condition of knee joint or if they are in active infection state
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
This group will include 24 participants, the interventions will be given for 35-45 mins.
All the participants will follow the same standardized exercise protocol 5 days a week, for 12 weeks.
|
the interventions will be given for 35-45 mins.
All the participants will follow the same standardized exercise protocol 5 days a week, for 12 weeks.
|
|
Active Comparator: Group B
This group will also include 24 participants, the interventions will be given for 20-30 mins.
All the participants will follow the same standardized exercise protocol 5 days a week, for 12 weeks.
|
the interventions will be given for 35-45 mins.
All the participants will follow the same standardized exercise protocol 5 days a week, for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric pain rating scale
Time Frame: 12 weeks
|
NPRS consists of a scale with 0-10 readings.
The zero denotes no pain while 1, 2, 3 denotes to mild pain, 4, 5, 6 denotes to moderate pain while 7-10 denotes to severe pain.
|
12 weeks
|
|
Kellgren and Lawrence system for classification of Osteoarthritis
Time Frame: 12 Weeks
|
This classification system consists of 5 grades with Grade 0 indicating normal joint and Grade 4 as maximal osteoarthritic activity in joint
|
12 Weeks
|
|
Knee Injury and Osteoarthritic outcome score (KOOS)
Time Frame: 12 weeks
|
The KOOS has five separate subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL)
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12 weeks
|
|
Goniometer
Time Frame: 12 weeks
|
Active range of Motion of the patient will be assessed using a universal goniometer for knee joint flexion and extension.
the data will be collected at baseline knee joint goniometry
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Sanaullah, MS, Riphah, Lahore 54000
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR& AHS/23/01100/Maryam
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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