- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06190977
Effects of OEP on Rehabilitation Outcomes on TKR Patients
Effects of the Otago Exercise Program on Rehabilitation Outcomes of Balance, Strength and Functional Outcomes in Post-Operative Total Knee Replacement Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Islamabad, Punjab, Pakistan
- NIRM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Otago Exercise Program
Warm-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 |
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
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|
Other: General TKR ptotocol
Ankle pumps Straight leg raises Heel slides Seated knee extensions Standing knee flexion Calf raises Quadriceps contraction Stationary bike
|
Exercises will include Intensity: 10 repetitions of each set, Frequency 5 sessions per week for 4 weeks.
Time= 30 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg balance scale
Time Frame: 4th week
|
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.
|
4th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
timed up and go (TUG) test
Time Frame: 4th week
|
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.
|
4th week
|
|
short physical performance battery
Time Frame: 4th week
|
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.
|
4th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara Aabroo, Nmpt, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Phu S, Kirk B, Bani Hassan E, Vogrin S, Zanker J, Bernardo S, Duque G. The diagnostic value of the Short Physical Performance Battery for sarcopenia. BMC Geriatr. 2020 Jul 13;20(1):242. doi: 10.1186/s12877-020-01642-4.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Farrah azeem
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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