NCT05877703

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 18, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

May 18, 2023

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

    up to 12 weeks

  • 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

    up to 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)

    up to 12 weeks

Study Arms (2)

Group A: close kinetic chain exercises

EXPERIMENTAL

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

Group B: open kinetic chain exercises

ACTIVE COMPARATOR

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

Interventions

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

Group A: close 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

Group B: open kinetic chain exercises

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Raee Trust Hospital

Gujranwala, Punjab Province, 54700, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 33666347BACKGROUND
  • 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.

    PMID: 32722615BACKGROUND
  • 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.

    PMID: 29340203BACKGROUND
  • 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.

    PMID: 33167714BACKGROUND
  • 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.

    PMID: 32784592BACKGROUND
  • 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.

    PMID: 35428274BACKGROUND
  • 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.

    PMID: 21071480BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Rida Shakeel, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2023

First Posted

May 26, 2023

Study Start

April 15, 2023

Primary Completion

September 1, 2023

Study Completion

September 15, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations