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

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
close kinetic chain exercises
open kinetic chain exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Al-Raee Trust HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A: close kinetic chain exercises

Group B: open kinetic chain exercises

Arm Description

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

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

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale:
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
Western Ontario and McMaster Universities Arthritis Index
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
Osteoarthritis Knee and Hip Quality of Life Score
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)

Secondary Outcome Measures

Full Information

First Posted
May 18, 2023
Last Updated
May 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05877703
Brief Title
Open Versus Close Chain Exercise Effects With Lifestyle Modification and Education in Knee Osteoarthritis
Official Title
Effects of Open Versus Close Kinetic Chain Exercise Training Program With Lifestyle Modification and Patient's Education in Grade 3 Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: close kinetic chain exercises
Arm Type
Experimental
Arm Description
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
Arm Title
Group B: open kinetic chain exercises
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
close kinetic chain exercises
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
open kinetic chain exercises
Intervention Description
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 Outcome Measure Information:
Title
Numeric Pain Rating Scale:
Description
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
Time Frame
up to 12 weeks
Title
Western Ontario and McMaster Universities Arthritis Index
Description
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
Time Frame
up to 12 weeks
Title
Osteoarthritis Knee and Hip Quality of Life Score
Description
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)
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghulam Fatima, PhD*
Phone
03034073057
Email
ghulam.fatima@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD*
Phone
051-5481826
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rida Shakeel, MS*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Raee Trust Hospital
City
Gujrānwāla
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghulam Fatima, PhD*
Phone
03034073057
Email
ghulam.fatima@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33666347
Citation
Raposo F, Ramos M, Lucia Cruz A. Effects of exercise on knee osteoarthritis: A systematic review. Musculoskeletal Care. 2021 Dec;19(4):399-435. doi: 10.1002/msc.1538. Epub 2021 Mar 5.
Results Reference
background
PubMed Identifier
32722615
Citation
Primorac D, Molnar V, Rod E, Jelec Z, Cukelj F, Matisic V, Vrdoljak T, Hudetz D, Hajsok H, Boric I. Knee Osteoarthritis: A Review of Pathogenesis and State-Of-The-Art Non-Operative Therapeutic Considerations. Genes (Basel). 2020 Jul 26;11(8):854. doi: 10.3390/genes11080854.
Results Reference
background
PubMed Identifier
29340203
Citation
Olagbegi OM, Adegoke BO, Odole AC. Effectiveness of three modes of kinetic-chain exercises on quadriceps muscle strength and thigh girth among individuals with knee osteoarthritis. Arch Physiother. 2017 Jul 19;7:9. doi: 10.1186/s40945-017-0036-6. eCollection 2017.
Results Reference
background
PubMed Identifier
33167714
Citation
Luan L, Bousie J, Pranata A, Adams R, Han J. Stationary cycling exercise for knee osteoarthritis: A systematic review and meta-analysis. Clin Rehabil. 2021 Apr;35(4):522-533. doi: 10.1177/0269215520971795. Epub 2020 Nov 10.
Results Reference
background
PubMed Identifier
32784592
Citation
Sanchez Romero EA, Fernandez Carnero J, Villafane JH, Calvo-Lobo C, Ochoa Saez V, Burgos Caballero V, Laguarta Val S, Pedersini P, Pecos Martin D. Prevalence of Myofascial Trigger Points in Patients with Mild to Moderate Painful Knee Osteoarthritis: A Secondary Analysis. J Clin Med. 2020 Aug 7;9(8):2561. doi: 10.3390/jcm9082561.
Results Reference
background
PubMed Identifier
35428274
Citation
Ng WH, Jamaludin NI, Sahabuddin FNA, Ab Rahman S, Ahmed Shokri A, Shaharudin S. Comparison of the open kinetic chain and closed kinetic chain strengthening exercises on pain perception and lower limb biomechanics of patients with mild knee osteoarthritis: a randomized controlled trial protocol. Trials. 2022 Apr 15;23(1):315. doi: 10.1186/s13063-022-06153-8.
Results Reference
background
PubMed Identifier
21071480
Citation
Goetz C, Ecosse E, Rat AC, Pouchot J, Coste J, Guillemin F. Measurement properties of the osteoarthritis of knee and hip quality of life OAKHQOL questionnaire: an item response theory analysis. Rheumatology (Oxford). 2011 Mar;50(3):500-5. doi: 10.1093/rheumatology/keq357. Epub 2010 Nov 11.
Results Reference
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Open Versus Close Chain Exercise Effects With Lifestyle Modification and Education in Knee Osteoarthritis

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