Effects of OEP on Rehabilitation Outcomes on TKR Patients

Not Applicable

Not yet recruiting

• Conditions: Total Knee Replacement
• Interventions: Other: Otago Exercise Program; Other: General TKR pprotocol

• Registration Number: NCT06190977
• Lead Sponsor: Riphah International University

Brief 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. 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.

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 Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Study Start: 2024-01-01
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Otago Exercise Program	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
General TKR ptotocol	General TKR pprotocol	Ankle pumps Straight leg raises Heel slides Seated knee extensions Standing knee flexion Calf raises Quadriceps contraction Stationary bike

Primary Outcome Measures

Name	Time	Method
Berg balance scale	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.

Secondary Outcome Measures

Name	Time	Method
timed up and go (TUG) test	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.
short physical performance battery	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.

Trial Locations

Locations (1)

NIRM; 🇵🇰 Islamabad, Punjab, Pakistan