Comparative Effectiveness of Otago and Neuromuscular Exercise Programs in Knee Osteoarthritis

NCT ID: NCT07078526

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2025-11-30

Brief Summary

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Otago Exercise Program

Participants in this arm will receive the Otago Exercise Program (OEP) consisting of 17 structured exercises (5 strengthening and 12 balance/proprioception exercises). Each session includes warm-up and cool-down, and lasts approximately 40 minutes. Sessions will be supervised twice weekly for a total duration of six weeks, in addition to standard physiotherapy (hot pack and gentle stretching).

Group Type: EXPERIMENTAL

Otago Exercise Program

Intervention Type: OTHER

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.

Neuromuscular Exercise

Participants in this arm will receive a structured neuromuscular exercise protocol including functional, proprioceptive, and balance exercises such as side stepping, high knees march, pelvic lifts, bridging with marching, lateral leg step, sit to stand, single leg clock reach, and single leg stand. Each session includes warm-up and cool-down, lasts approximately 40 minutes, and will be supervised twice weekly for six weeks, alongside standard physiotherapy (hot pack and gentle stretching).

Group Type: ACTIVE_COMPARATOR

Neuromuscular Exercise

Intervention Type: OTHER

The neuromuscular exercise intervention involves functional, proprioceptive, and balance exercises delivered twice weekly for six weeks under supervision, in addition to standard physiotherapy care.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

OEP; NME

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahnoor Butt, MSc OMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Amna Zia, Phd Scholar

Role: PRINCIPAL_INVESTIGATOR

Mayo Hospital/ Riphah International University

Locations

Kulsoom Sultan Medical centre

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Samrood Akram, Phd Scholar

Role: CONTACT

samood.akram@riphah.edu.pk

03324806143

Amna Zia, Phd Scholar

Role: CONTACT

amna_zia_17@live.com

03244686993

Facility Contacts

Dr Noor-ul-ain

Role: primary

03026949837

References

.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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

National Library of Medicine (U.S.). Exercise for osteoarthritis of the knee (NCT06329128). ClinicalTrials.gov. 2024. Available from: https://clinicaltrials.gov/ct2/show/NCT0632912

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 36339194 (View on PubMed)

Other Identifiers

REC/RCR & AHS/24/0163

Identifier Type: -

Identifier Source: org_study_id