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Total Knee ReplacementNCT06190977

Effects of OEP on Rehabilitation Outcomes on TKR Patients

A study testing Otago Exercise Program and General TKR pprotocol in people with Total Knee Replacement, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this research is to assess the effects of the Otago Exercise Program on Rehabilitation outcomes of balance strength and functional outcomes of post Total Knee Replacement patients. A randomized controlled trial that will include a total of 44 participants divided into two groups control and experimental. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Total Knee Replacement
What is being tested?
Otago Exercise Program and General TKR pprotocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 sitePakistan
Study dates
1 Jan 2024to 28 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Both genders
  • Age 45 or above
  • 3-6 weeks since replacement surgery
  • Berge balance scale 21-40
  • Patients should have received medical clearance from their surgeon or health care provider to engage in an exercise program

Who cannot join

  • History of recent musculoskeletal injury of lower limb
  • Patients have undergone revision TKR
  • Patient with moderate cognitive impairment
  • Patients with unstable medical conditions or active infection
  • Patient with specific contraindications to exercise as determined by their healthcare provider such as blood clots or severe osteoporosis.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • NIRM

    Islamabad, Punjab Province

Other trials in Pakistan

About this study

Official title: Effects of the Otago Exercise Program on Rehabilitation Outcomes of Balance, Strength and Functional Outcomes in Post-Operative Total Knee Replacement Patients

The aim of this research is to assess the effects of the Otago Exercise Program on Rehabilitation outcomes of balance strength and functional outcomes of post Total Knee Replacement patients. A randomized controlled trial that will include a total of 44 participants divided into two groups control and experimental. The experimental group will receive the Otago Exercise Program for four weeks, three times per week for forty to forty-five minutes. The control group will receive general TKR protocol for four weeks, three times per week for 30 minutes. Data collected will be analyzed through SPSS 25.

Read the detailed description

Total knee replacement (TKR) is one of the most effective surgical interventions for the relief of pain and functional recovery in patients with advanced osteoarthritis (OA) of the knee. In this procedure, the knee joint is resurfaced with a metal or plastic implant intended to restore function, provide pain relief, and improve quality of life.

According to a study in Pakistan, a total of 14,875 people had total knee replacement in the last seven years from 2014 to 2021 with a rate of 14.8/100,000 population. In the United States, estimates of TKR incidence lie at 400,000 each year, a figure expected to grow 143% by 2050 even through conservative projections.

TKR is considered one of the most effective procedures in orthopedic surgery, but electing for it is far from straightforward: noninvasive alternatives such as weight loss, physical therapy, and NSAIDs are first exhausted. If unsuccessful, a patient will undergo a thorough examination of clinical history and comprehensive imaging of the joint to determine if a TKR is feasible, and if so, the desired implant design and size.

Despite the improvements in surgical techniques, the outcomes after TKR remain strongly influenced by the adequacy of rehabilitation and the consequent functional recovery.

Rehabilitation, with a particular emphasis on physiotherapy and exercise, is widely promoted after TKR. During the hospital stay, physiotherapy targets mobilization and achievement of functional goals relating to hospital discharge. Further post-discharge physiotherapy and exercise-based interventions promote strength and balance re-training and functional improvement. However, the provision of these services varies in content and duration.

However, it has been reported that patients with TKR do not fully recover balance and proprioception in the long-term, remaining clearly below the "abilities" of their healthy matched controls. Low balance and proprioception have been ascribed to the loss of knee receptors located in the structures such as the menisci, the cruciate ligaments, and the cartilage, which are removed for the prosthesis implant.

The Otago Exercise Program (OEP) is a home-based balance and strength training program that reduces falls and promotes muscle strength and balance in daily life.OEP is a multi-modal training method that integrates warm-up exercises (5 movements), progressive muscle strength training (5 movements), balance training (12 movements), walking sessions, and aerobic exercise. Initially, The most significant effects on fall reduction induced by the Otago program were only seen in patients who are 80 years or older but now it has shown promise in diverse rehabilitation contexts. Considering that muscle strength and balance are critical factors of TKR postoperative rehabilitation, it is plausible that postoperative OEP may provide further benefits.

This study will explore the effects of postoperative OEP on rehabilitation outcomes of balance, strength, and functional outcomes in TKR patients in regard to reducing postoperative fall occurrence and enhancing knee function. It is hypothesized that this program (OEP) would be effective with these individuals in accelerating rehabilitation and lowering the risks of falling. We constructed a 4-week intervention plan based on pre-, post and after 2nd week follow-up intervention measures of Otago exercise, and explored more effective intervention strategies of functional exercise after total knee replacement.

Being tested
Otago Exercise Program, General TKR pprotocol
Keywords
Otago Exercise Program, balance, strength, osteoarthritis, ADLs
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Otago Exercise ProgramOther

    Exercises will include Intensity: 10 repetitions of each set for the first two weeks and 15 repetitions of each set for the last two weeks, Frequency 3 sessions per week for 4 weeks. Time= 40-45 minutes

  • General TKR pprotocolOther

    Exercises will include Intensity: 10 repetitions of each set, Frequency 5 sessions per week for 4 weeks. Time= 30 minutes

Study groups in NCT06190977
Study groupRoleWhat they receive
Otago Exercise ProgramExperimentalWarm-up activities for 5 min head movement, neck movement, back stretching, trunk movement, and ankle movement. strength and balance training for 30 mins Strengthening training include sitting knee extension, standing hip abduction, standing knee flexion, tiptoe and heel tiptoe Balance training include standing on one foot, walking in the shape of the number eight, walking sideways, walking backward, standing to sit position training, knee bending, toe to heel standing, heel walking, toe to heel walking, toe to heel walking, toe to heel walking, toe to heel walking backward, and climbing stairs Walking training for 10 min
Receives: Other: Otago Exercise Program
General TKR ptotocolOtherAnkle pumps Straight leg raises Heel slides Seated knee extensions Standing knee flexion Calf raises Quadriceps contraction Stationary bike
Receives: Other: General TKR pprotocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Berg balance scale

    Consists of 14 tasks and total score of 56.score of 0-20 indicates severe fall risk, 20-45 includes moderate risk of fall and 45-60 illustrates thr functional balances state.

    Measured: 4th week

Secondary outcomes (2)
  1. timed up and go (TUG) test

    The test measures the time it takes for a person to stand up from a chair, walk a short distance (typically 3 meters) turn around, return and sit back down.

    Measured: 4th week

  2. short physical performance battery

    The test includes three different domains (walking, sit-to-stand and balance) to assess functional mobility. The test is easy to administer and takes approximately 10 mins. The SPPB includes three sub tests.

    Measured: 4th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start1 Jan 2024
  3. Primary completion30 Dec 2024
  4. Study completion28 Jan 2025

Resources

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
Assignment
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06190977
Sponsor's protocol ID
Farrah azeem
Status last verified
Jul 2025
First submitted
19 Dec 2023
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nakano N, Shoman H, Olavarria F, Matsumoto T, Kuroda R, Khanduja V. Why are patients dissatisfied following a total knee replacement? A systematic review. Int Orthop. 2020 Oct;44(10):1971-2007. doi: 10.1007/s00264-020-04607-9. Epub 2020 Jul 8.

    PubMed 32642827
  • Bukhari SI, Allana AR, Najjad KR, Noor SS, Chinoy A. Epidemiology of hip & knee replacement across Pakistan: Multicenter cross-sectional study. Pak J Med Sci. 2023 Nov-Dec;39(6):1557-1561. doi: 10.12669/pjms.39.6.7006.

    PubMed 37936780
  • Tolpadi AA, Lee JJ, Pedoia V, Majumdar S. Deep Learning Predicts Total Knee Replacement from Magnetic Resonance Images. Sci Rep. 2020 Apr 14;10(1):6371. doi: 10.1038/s41598-020-63395-9.

    PubMed 32286452
  • Jester R, Rodney A. The relationship between obesity and primary Total Knee Replacement: A scoping review of the literature. Int J Orthop Trauma Nurs. 2021 Jul;42:100850. doi: 10.1016/j.ijotn.2021.100850. Epub 2021 Feb 16.

    PubMed 34044216
  • Bravi M, Longo UG, Laurito A, Greco A, Marino M, Maselli M, Sterzi S, Santacaterina F. Supervised versus unsupervised rehabilitation following total knee arthroplasty: A systematic review and meta-analysis. Knee. 2023 Jan;40:71-89. doi: 10.1016/j.knee.2022.11.013. Epub 2022 Nov 18.

    PubMed 36410253
  • Hadamus A, Bialoszewski D, Blazkiewicz M, Kowalska AJ, Urbaniak E, Wydra KT, Wiaderna K, Boratynski R, Kobza A, Marczynski W. Assessment of the Effectiveness of Rehabilitation after Total Knee Replacement Surgery Using Sample Entropy and Classical Measures of Body Balance. Entropy (Basel). 2021 Jan 29;23(2):164. doi: 10.3390/e23020164.

    PubMed 33573057
  • de Lima F, Melo G, Fernandes DA, Santos GM, Rosa Neto F. Effects of total knee arthroplasty for primary knee osteoarthritis on postural balance: A systematic review. Gait Posture. 2021 Sep;89:139-160. doi: 10.1016/j.gaitpost.2021.04.042. Epub 2021 Apr 30.

    PubMed 34284334
  • Dominguez-Navarro F, Silvestre-Munoz A, Igual-Camacho C, Diaz-Diaz B, Torrella JV, Rodrigo J, Paya-Rubio A, Roig-Casasus S, Blasco JM. A randomized controlled trial assessing the effects of preoperative strengthening plus balance training on balance and functional outcome up to 1 year following total knee replacement. Knee Surg Sports Traumatol Arthrosc. 2021 Mar;29(3):838-848. doi: 10.1007/s00167-020-06029-x. Epub 2020 Apr 27.

    PubMed 32342139
  • Labanca L, Iovine R, Bragonzoni L, Barone G, Farella GM, Benedetti MG. Instrumented platforms for balance and proprioceptive assessment in patients with total knee replacement: A systematic review and meta-analysis. Gait Posture. 2020 Sep;81:230-240. doi: 10.1016/j.gaitpost.2020.07.080. Epub 2020 Aug 8.

    PubMed 32810699
  • Sun JN, Shan YZ, Wu LX, Li N, Xu FH, Kong XR, Zhang B. Preoperative high-intensity strength training combined with balance training can improve early outcomes after total knee arthroplasty. J Orthop Surg Res. 2023 Sep 15;18(1):692. doi: 10.1186/s13018-023-04197-3.

    PubMed 37715204
  • Chiu HL, Yeh TT, Lo YT, Liang PJ, Lee SC. The effects of the Otago Exercise Programme on actual and perceived balance in older adults: A meta-analysis. PLoS One. 2021 Aug 6;16(8):e0255780. doi: 10.1371/journal.pone.0255780. eCollection 2021.

    PubMed 34358276
  • Peng Y, Yi J, Zhang Y, Sha L, Jin S, Liu Y. The effectiveness of a group-based Otago exercise program on physical function, frailty and health status in older nursing home residents: A systematic review and meta-analysis. Geriatr Nurs. 2023 Jan-Feb;49:30-43. doi: 10.1016/j.gerinurse.2022.10.014. Epub 2022 Nov 19.

    PubMed 36413811
  • Viveiro LAP, Gomes GCV, Bacha JMR, Carvas Junior N, Kallas ME, Reis M, Jacob Filho W, Pompeu JE. Reliability, Validity, and Ability to Identity Fall Status of the Berg Balance Scale, Balance Evaluation Systems Test (BESTest), Mini-BESTest, and Brief-BESTest in Older Adults Who Live in Nursing Homes. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):E45-E54. doi: 10.1519/JPT.0000000000000215.

    PubMed 30407272
  • Demircioglu A, Kezban Sahin U, Acaroz S. Discriminative Ability of the Four Balance Measures for Previous Fall Experience in Turkish Community-Dwelling Older Adults. J Aging Phys Act. 2022 Mar 18;30(6):980-986. doi: 10.1123/japa.2021-0415. Print 2022 Dec 1.

    PubMed 35303710
  • Lauretani F, Ticinesi A, Gionti L, Prati B, Nouvenne A, Tana C, Meschi T, Maggio M. Short-Physical Performance Battery (SPPB) score is associated with falls in older outpatients. Aging Clin Exp Res. 2019 Oct;31(10):1435-1442. doi: 10.1007/s40520-018-1082-y. Epub 2018 Dec 4.

    PubMed 30515724

Questions about this trial

What is this clinical trial studying?

A study testing Otago Exercise Program and General TKR pprotocol in people with Total Knee Replacement, 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 8 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg balance scale (time frame: 4th week). 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 NCT06190977, which also lists 16 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 8 Jul 2025.

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