Knee OsteoarthritisNCT07078526
Comparative Effectiveness of Otago and Neuromuscular Exercise Programs in Knee Osteoarthritis
A study testing Otago Exercise Program and Neuromuscular Exercise in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Otago Exercise Program and Neuromuscular Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Kulsoom Sultan Medical centre
Lahore, Punjab Province, 54000
Dr Noor-ul-ain, 03026949837
About this study
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
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.
Read the 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
- Being tested
- Otago Exercise Program, Neuromuscular Exercise
- Keywords
- Otago Exercise Program, Neuromuscular Exercises, Knee Osteoarthritis, Pain Management, Functional Status, Postural Control, Balance
- Medical subject headings
- Osteoarthritis, Knee, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise ProgramOther
Also called OEP
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 ExerciseOther
Also called NME
The neuromuscular exercise intervention involves functional, proprioceptive, and balance exercises delivered twice weekly for six weeks under supervision, in addition to standard physiotherapy care.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Neuromuscular Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 3, Week 6
Secondary outcomes (3)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to measure pain, stiffness, and physical function in patients with knee osteoarthritis.
Measured: Baseline, Week 3, Week 6
Timed Up and Go (TUG)
The Timed Up and Go (TUG) test will measure functional mobility by recording the time taken to stand up, walk 3 meters, return, and sit down.
Measured: Baseline, Week 3, Week 6
Modified Clinical Test of Sensory Interaction in Balance (mCTSIB)
The Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) will assess postural control by measuring sway under different sensory conditions.
Measured: Baseline, Week 3, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahnoor Butt, MSc OMPT, Principal investigator, Riphah International UniversityAmna Zia, Phd Scholar, Principal investigator, Mayo Hospital/ Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078526
- Sponsor's protocol ID
- REC/RCR & AHS/24/0163
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36339194
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07078526
- Acronym / sponsor ID
- REC/RCR & AHS/24/0163
- Conditions
- Knee Osteoarthritis
- Keywords
- Otago Exercise Program, Neuromuscular Exercises, Knee Osteoarthritis, Pain Management, Functional Status, Postural Control, Balance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Otago Exercise Program | Experimental | Other: Otago Exercise ProgramParticipants 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). |
| Neuromuscular Exercise | Active comparator | Other: Neuromuscular ExerciseParticipants 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). |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Otago Exercise ProgramAlso: OEPThe 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 | Otago Exercise Program |
| Neuromuscular ExerciseAlso: NMEThe neuromuscular exercise intervention involves functional, proprioceptive, and balance exercises delivered twice weekly for six weeks under supervision, in addition to standard physiotherapy care. | Other | Neuromuscular Exercise |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, Week 3, Week 6
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Background.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.
- BackgroundTauqeer 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.
- BackgroundRao 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
- BackgroundMalik 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
- BackgroundNational Library of Medicine (U.S.). Exercise for osteoarthritis of the knee (NCT06329128). ClinicalTrials.gov. 2024. Available from: https://clinicaltrials.gov/ct2/show/NCT0632912
- Background: PubMed 36339194Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahnoor Butt, MSc OMPT principal investigator
Riphah International University
Amna Zia, Phd Scholar principal investigator
Mayo Hospital/ Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago Exercise Program and Neuromuscular Exercise in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samrood Akram, Phd Scholar (03324806143, samood.akram@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: Baseline, Week 3, Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07078526, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.