Open Versus Close Chain Exercise Effects With Lifestyle Modification and Education in Knee Osteoarthritis

March 4, 2024 updated by: Riphah International University

Effects of Open Versus Close Kinetic Chain Exercise Training Program With Lifestyle Modification and Patient's Education in Grade 3 Knee Osteoarthritis

A randomized clinical trial will be conducted in Gujranwala and 24 patients with grade 3 knee OA will be recruited. After consent, patients will be randomly allocated into 2 groups by lottery method. Group A will do close kinetic chain exercises, including static cycling, lifestyle modification, and patient education. Group B will do open kinetic chain exercises including quadriceps drills with lifestyle modification and patient education. A total duration of 12 weeks with 3 sessions per week will be given. Outcome measures Assessment will be done at 0 weeks, 4 weeks, 8 weeks, and 12 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis is a clinical syndrome characterized by joint pain, varying degrees of functional impairment, and a poor quality of life and in 21st century It is predicted that the number of persons over 65 would double placing a heavy burden on healthcare systems and caregivers' resources. For individuals with knee OA, open kinetic chain (OKC) and closed kinetic chain (CKC) exercises have been recommended thus far. The distal segment of the body components can move freely during OKC exercise since it is not bound, but remain static on the ground during CKC exercise.

A single-blinded randomized clinical trial will be conducted at Al-Raee Trust Hospital Gujranwala and 24 patients of both genders and age of 50-70 years with grade 3 knee OA (according to Kellgren and Lawrence classification system based on plain x-rays) will be recruited. After taking written consent, patients will be randomly allocated into 2 groups by lottery method. Group A will be treated with close kinetic chain exercises including static cycling with lifestyle modification and patient's education and group B will be treated with open kinetic chain exercises including quadriceps drill with lifestyle modification and patient's education about 30 minutes per session including 10 min of walking as a warm up for total duration of 12 weeks with 3 sessions per week. Outcome measures such as pain, disability and health status will be assessed by NPRS, WOMAC and OAKHQOL respectively. Assessment will be done by therapist at 0 week, 4 weeks, 8 weeks and 12 weeks.

Study Type

Interventional

Enrollment (Actual)

24

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

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Gujrānwāla, Punjab, Pakistan, 54700
        • Al-Raee Trust Hospital

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:

  • • Both genders

    • With Grade 3 of Knee Osteoarthritis (Kellgren-Lawrence scoring)
    • Mild-to-moderate pain on NPRS
    • Age 50-70 years old
    • Available three times a week for over 3 months

Exclusion Criteria:

  • • Having Knee surgery in the past 6 months

    • Having Acute symptomatic KOA
    • Having Any muscular, joint or neurological conditions that affect lower limb function
    • Conducting another structured exercise programme specifically for KOA during this study period
    • Having Motor neuron disorders such as Alzheimer's and Parkinson's diseases.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: close kinetic chain exercises
Group A will be treated with close kinetic chain exercises including static cycling with lifestyle modification and patient's education including quadriceps drill with lifestyle modification and patient's education about 30 minutes per session including 10 min of walking as a warm up for total duration of 12 weeks with 3 sessions per week. Assessment will be done by therapist at 0 week, 4 weeks, 8 weeks and 12 weeks
Other: close kinetic chain exercises
CKC include mini squats, leg press, step-up and step-down, wall slides etc along with their respective modality as quadriceps drill and static cycle ergometer respectively on grade-3 knee OA patients
Active Comparator: Group B: open kinetic chain exercises
Group B will be treated with open kinetic chain exercises including quadriceps drill with lifestyle modification and patient's education about 30 minutes per session including 10 min of walking as a warm up for total duration of 12 weeks with 3 sessions per week. Group B performed scar mobilization exercises only for 3 weeks. Assessment will be done by therapist at 0 week, 4 weeks, 8 weeks and 12 weeks
Other: open kinetic chain exercises
The distal segment of the body components can move freely during OKC exercise.OKC exercises include quadriceps setting, knee extension in sitting and straight leg raise in lying position; it also includes quadriceps drills as part of OKC exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale:
Time Frame: up to 12 weeks
Pain intensity will be assessed by NPRS. The 11-point NPRS (intervals from 0-10) is used to quantify pain intensity; 0 represents no pain, and 10 represent the worst possible agony. The NPRS is an valid and reliable instrument for older persons. Participants will be asked to select the number that most accurately describes their level of pain. At the baseline assessment, following each exercise session during the 12-week intervention, and finally at the end of the intervention programme, the NPRS scores will be recorded
up to 12 weeks
Western Ontario and McMaster Universities Arthritis Index
Time Frame: up to 12 weeks
This questionnaire is designed to evaluate an osteoarthritis patient's level of disability. It consists of 24 items that assess the patient's health and function in a variety of ways, including: clinical symptoms (5 questions), the severity of joint stiffness (2 questions), and daily living activities (17 questions). There are five subscales for each question, with the best situation scoring as never or none and the worst situation scoring as extreme or always. Higher ratings in this case indicate a better position and less suffering. Scores will be recorded after each session of intervention at 0 week, 4 weeks, 8 weeks and 12 weeks
up to 12 weeks
Osteoarthritis Knee and Hip Quality of Life Score
Time Frame: up to 12 weeks
The Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) was created to assess patients with hip and knee OA's quality of life particularly. The OAKHQOL is a reliable and valid tool for measuring the health-related quality of life of people with knee OA. Physical activities (16 items), mental health (13 items), pain (4 items), social support (4 items), social functioning (3 items), and 3 independent items are among the 43 items that make up the OAKHQOL questionnaire, which describes quality of life in five domains. Each item is graded from 0 to 10 on a scale. The mean of all the components constitutes the final score. The sum of all the mean scores will result in a scale from 0 (the highest achievable QOL) to 100 (worst possible QOL)
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Rida Shakeel, MS*, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 15, 2023

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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