Clinical trial NCT05877703: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Numeric Pain Rating Scale:
timeFrame: up to 12 weeks
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: up to 12 weeks
measure: Osteoarthritis Knee and Hip Quality of Life Score
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gujrānwāla
country: Pakistan
facility: Al-Raee Trust Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Rida Shakeel, MS*
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.