NCT07078526

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 14, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 14, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

Otago Exercise ProgramNeuromuscular ExercisesKnee OsteoarthritisPain ManagementFunctional StatusPostural ControlBalance

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating Scale (NPRS)

    Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), a validated 0-10 scale where higher scores indicate greater pain. Change from baseline to 6 weeks will be analyzed.

    Baseline, Week 3, Week 6

Secondary Outcomes (3)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Baseline, Week 3, Week 6

  • Timed Up and Go (TUG)

    Baseline, Week 3, Week 6

  • Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)

    Baseline, Week 3, Week 6

Study Arms (2)

Otago Exercise Program

EXPERIMENTAL

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).

Other: Otago Exercise Program

Neuromuscular Exercise

ACTIVE COMPARATOR

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).

Other: Neuromuscular Exercise

Interventions

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.

Also known as: OEP
Otago Exercise Program

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

Also known as: NME
Neuromuscular Exercise

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kulsoom Sultan Medical centre

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

  • .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.

    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.

    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

    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

    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

    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.

    PMID: 36339194BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeAgnosia

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mahnoor Butt, MSc OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Amna Zia, Phd Scholar

    Mayo Hospital/ Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samrood Akram, Phd Scholar

CONTACT

Amna Zia, Phd Scholar

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a parallel manner to either the Otago Exercise Program group or the neuromuscular exercise group, receiving their assigned intervention concurrently over six weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2025

First Posted

July 22, 2025

Study Start

July 15, 2025

Primary Completion

November 15, 2025

Study Completion

November 30, 2025

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations