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NCT Number: NCT05877703

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Raee Trust Hospital

Guiranwala, Punjab Province, 54700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

close kinetic chain exercises

Other

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

open kinetic chain exercises

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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)

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 26, 2023
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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