- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06407778
Comparison of High Intensity Strength Training and Muscle Energy Techniques in TKR Patients
Comparison of Effects of High Intensity Strength Training and Muscle Energy Technique on Pain, ROM and Functional Status in Patients With Total Knee Replacement
Study Overview
Status
Intervention / Treatment
Detailed Description
The main objective of this study is to compare two different rehabilitation strategies: Muscle Energy Techniques with Balance Exercises and High Intensity Strength Training with Balance Exercises. The research aims to maximize postoperative results for patients who have undergone total knee replacement surgery.
The focus on resistance exercises intended to improve muscle strength and power is what defines high intensity strength training, or HIST. Research has indicated that HIST is beneficial in enhancing joint stability, muscle function, and overall functional outcomes across a range of orthopedic groups. Its precise use and effect on patients recovering from TKR surgery, however, need further investigation. In order to increase joint mobility, lessen pain, and improve neuromuscular control, patients who get Muscle Energy Techniques (MET) actively participate in targeted muscle contractions. MET has demonstrated potential in treating muscular imbalances.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Punjab
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Lahore, Punjab, Pakistan, 05450
- Horizon Hospital Lahore
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals between the ages of 45 and 75
- Patients should be within a certain timeframe following surgery (e.g., post op day 0-day) to ensure homogeneity throughout the rehabilitation phase.
- Patients who have had primary total knee replacement
- To take part in the RCT, participants must give informed consent
- they must be able and willing to follow the study protocol's instructions for post-rehabilitation care.
Exclusion Criteria:
- Comorbidities: Individuals with significant comorbidities affecting rehabilitation, such as severe cardiovascular disease or neuromuscular disorders, may be excluded.
- Allergies/Contraindications: Patients with allergies or contraindications to specific exercises or techniques used in the study.
- Inadequate Cognitive Function: Participants with cognitive impairments that prevent them from comprehending and adhering to the rehabilitation protocols.
- Other Knee Surgeries: Patients who have had other knee surgeries or have had bilateral knee replacements may be excluded due to variations in recovery and rehabilitation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Intensity Strength Training
Group of TKR patients are given high intensity strength training.
|
|
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Active Comparator: Muscle Energy Technique Exercises
patients are given muscle energy technique exercise.
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The Muscle Energy Technique (MET) to strengthen and flex your quadriceps and hamstrings.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ROM
Time Frame: 4th week
|
An instrument called a goniometer will be used to measure angles or rotate objects into desired positions. In orthopedics, it is primarily used to quantify joint angles. Changes from the baseline was taken. |
4th week
|
|
Functional Status: Knee Injury and Osteoarthritis outcome score
Time Frame: 4th week
|
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopedic scales, and generic measures.
Scores between 0 and 100 represent the percentage of the total possible score achieved.
|
4th week
|
|
Pain : Numeric Pain Rating Scale
Time Frame: 4th week
|
A simple tool for measuring pain intensity is the Numeric Pain Rating Scale. This grading system has eleven points: zero represents no pain, and ten represents the "worst pain imaginable or highest level of discomfort. Changes from the baseline was taken. |
4th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hafiza Amna Tariq, DPT, Riphah International University
Publications and helpful links
General Publications
- Bade MJ, Stevens-Lapsley JE. Early high-intensity rehabilitation following total knee arthroplasty improves outcomes. J Orthop Sports Phys Ther. 2011 Dec;41(12):932-41. doi: 10.2519/jospt.2011.3734. Epub 2011 Sep 30.
- 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.
- Casana J, Calatayud J, Ezzatvar Y, Vinstrup J, Benitez J, Andersen LL. Preoperative high-intensity strength training improves postural control after TKA: randomized-controlled trial. Knee Surg Sports Traumatol Arthrosc. 2019 Apr;27(4):1057-1066. doi: 10.1007/s00167-018-5246-2. Epub 2018 Oct 25.
- Irrgang JJ, Snyder-Mackler L, Wainner RS, Fu FH, Harner CD. Development of a patient-reported measure of function of the knee. J Bone Joint Surg Am. 1998 Aug;80(8):1132-45. doi: 10.2106/00004623-199808000-00006.
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/01104
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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