Comparative Effectiveness of Otago and Neuromuscular Exercise Programs in Knee Osteoarthritis

Official title

Comparison of the Effectiveness of the Otago Exercise Program (Oep) and Neuromuscular Exercises on Pain, Functional Status, Postural Control, and Balance in Patients With Knee Osteoarthritis

Overview

This randomized controlled trial aims to compare the effects of the Otago Exercise Program (OEP) and neuromuscular exercises on pain, functional status, postural control, and balance in patients with knee osteoarthritis (KOA). A total of 58 participants with X-ray confirmed Grade 2-3 KOA will be enrolled from clinical centers in Lahore, Pakistan. Eligible participants will be randomly assigned to either the OEP group or the neuromuscular exercise group. Both groups will receive standardized physiotherapy alongside their respective interventions twice weekly for six weeks. Outcomes including pain (NPRS), functional status (WOMAC), dynamic mobility (TUG), and postural control (mCTSIB) will be measured at baseline, week 3, and week 6. Data will be analyzed to determine which intervention provides greater improvements in pain reduction, functional capacity, mobility, and balance. This study is expected to inform clinical practice by identifying a more effective exercise approach for managing KOA symptoms and enhancing patients' quality of life.

Detailed description

Knee osteoarthritis (KOA) is a highly prevalent degenerative joint disease that significantly impairs mobility, functional capacity, and balance, often resulting in increased fall risk and reduced quality of life. Exercise-based interventions are widely recognized as key components of conservative management for KOA, yet comparative evidence for specific programs remains limited.

This randomized controlled trial is designed to compare the effectiveness of the Otago Exercise Program (OEP) and neuromuscular exercises in managing pain, improving functional status, enhancing postural control, and restoring balance in patients with Grade 2-3 knee osteoarthritis.

Eligible participants aged 45-65 years, with confirmed KOA and fulfilling inclusion criteria, will be recruited from multiple clinical centers in Lahore, Pakistan. After providing informed consent, participants will be randomized into two groups using computer-generated allocation with concealed envelopes.

Group A (OEP group) will receive the Otago Exercise Program, which consists of 17 structured exercises targeting lower limb strength and balance. Each session will include a warm-up, exercise circuit, and cool-down, conducted twice per week for six weeks under supervision.

Group B (neuromuscular group) will perform a series of neuromuscular exercises focused on functional, proprioceptive, and balance training. This protocol, also including warm-up and cool-down, will match the frequency and duration of the OEP group.

Both groups will receive standardized physiotherapy, including pain-relief modalities and gentle stretching exercises. Outcome measures, Numeric Pain Rating Scale (NPRS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Timed Up and Go (TUG), and Modified Clinical Test of Sensory Interaction in Balance (mCTSIB), will be collected at baseline, 3 weeks, and 6 weeks by an independent blinded assessor.

Data will be analyzed using appropriate parametric and non-parametric tests to evaluate within-group and between-group differences over time. It is hypothesized that both exercise interventions will yield significant improvements in pain and functional measures, but the Otago Exercise Program may offer superior benefits in balance and mobility performance.

Findings from this study are expected to guide clinicians in selecting effective exercise regimens to optimize rehabilitation outcomes and reduce the burden of knee osteoarthritis in the community.

Interventions

• Other Otago Exercise Program
  The Otago Exercise Program is a structured, progressive exercise regimen focusing on lower limb strengthening and balance retraining. It is performed twice weekly for six weeks under physiotherapist supervision, complementing standard physiotherapy care.
• Other Neuromuscular Exercise
  The neuromuscular exercise intervention involves functional, proprioceptive, and balance exercises delivered twice weekly for six weeks under supervision, in addition to standard physiotherapy care.

Primary outcome measures

• Numeric Pain Rating Scale (NPRS) [Time frame: Baseline, Week 3, Week 6]

Secondary outcome measures (3)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Time frame: Baseline, Week 3, Week 6]
• Timed Up and Go (TUG) [Time frame: Baseline, Week 3, Week 6]
• Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) [Time frame: Baseline, Week 3, Week 6]

Eligibility criteria

Inclusion criteria

• Adults aged 45 to 65 years
• X-ray confirmed Grade 2-3 knee osteoarthritis (Kellgren-Lawrence scale)
• NPRS pain score between 3 and 8
• TUG score ≥ 14 seconds
• Able and willing to participate in twice-weekly sessions for six weeks
• Signed informed consent

Exclusion criteria

• History of heart attack or stroke within the past year
• Knee or hip surgery within the past 6 months
• Resting systolic blood pressure >160 mmHg or <100 mmHg
• Resting diastolic blood pressure >100 mmHg or <60 mmHg
• Neurological disorders affecting balance
• Current participation in another exercise program
• Recent fractures, cancer, or vascular diseases

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Kulsoom Sultan Medical centre — Lahore

Publications

• .KATRE KA, PUSHPARAJ V, PAUL J. Effect of Otago Exercise Program (OEP) and Strength Training Program (STP) on leg strength and risk of fall among bilateral knee osteoarthritis patients. IJMAES. 2019;5(1):536-51.
• Tauqeer S, Shakeel H, Ikram A, Kafeel F, ul Ain N, Farooq N. Frequency of Grade (III) Knee Osteoarthritis (OA) Among Women in Lahore Pakistan: Grade (III) Knee Osteoarthritis (OA) Among Women. Pakistan BioMedical Journal. 2021;4(2):258-62.
• Rao RDM, Methe AD, Patil H, Prabhakar R. Effect of Otago exercise versus dual task net step exercise on balance and functional mobility in community dwelling elderly person with knee osteoarthritis-a randomised control trial. International Journal of Health Sciences and Research. 2021;11:179-87
• Malik FB, Memon AG, Shah S, Latif D, Afzal MF, Memon SA. PREVALENCE OF KNEE OSTEOARTHRITIS AND QUALITY OF LIFE AMONG MIDDLE AGED ADULTS OF PAKISTAN: soi: 21-2017/re-trjvol06iss01p280. The Rehabilitation Journal. 2022;6(01):280-3
• National Library of Medicine (U.S.). Exercise for osteoarthritis of the knee (NCT06329128). ClinicalTrials.gov. 2024. Available from: https://clinicaltrials.gov/ct2/show/NCT0632912
• Yang Y, Wang K, Liu H, Qu J, Wang Y, Chen P, Zhang T, Luo J. The impact of Otago exercise programme on the prevention of falls in older adult: A systematic review. Front Public Health. 2022 Oct 20;10:953593. doi: 10.3389/fpubh.2022.953593. eCollection 2022. PMID 36339194

Identifiers

NCT: NCT07078526 · REC/RCR & AHS/24/0163

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗