Knee OsteoarthritisNCT06407778
Comparison of High Intensity Strength Training and Muscle Energy Techniques in TKR Patients
A study testing High Intensity Strength Training and Muscle Energy Technique in people with Knee Osteoarthritis and Arthroplasty, Knee Replacement, run by Riphah International University at 1 site in Pakistan.
Trial summary
Globally, the prevalence of total joint replacement (TKR) procedures has been rising, providing patients with better joint function, decreased pain, and enhanced quality of life. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis, Arthroplasty, Knee Replacement, Resistance Training
- What is being tested?
- High Intensity Strength Training and Muscle Energy Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jan 2025to 12 Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effects of High Intensity Strength Training and Muscle Energy Technique on Pain, ROM and Functional Status in Patients With Total Knee Replacement
Globally, the prevalence of total joint replacement (TKR) procedures has been rising, providing patients with better joint function, decreased pain, and enhanced quality of life. A thorough and successful postoperative rehabilitation program, which attempts to restore optimal function and lower the risk of problems related to the treatment, is necessary for the success of total knee replacement (TKR) procedures. After total knee replacement, postoperative rehabilitation is a crucial stage in the patient's healing process. Normal knee function is frequently hampered by issues like pain management, muscular weakness, joint stiffness, and proprioceptive deficiencies. Therefore, choosing a suitable rehabilitation regimen is crucial.
Read the 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.
- Being tested
- High Intensity Strength Training, Muscle Energy Technique
- Keywords
- Total Knee Replacement, Knee Osteoarthritis, Strength Training, Muscle Energy Technique
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Strength TrainingOther
- High-intensity workouts to strengthen the quadriceps and enhance knee function;
- Knee flexion and extension 10 lbs.
- 10RM of hip flexion and extension
- 10RM hip adduction and abduction
- Standing with feet aligned for one minute*2, standing on one leg's forefoot and the other leg's heel for two minutes*2, standing on one foot for three seconds*15, and walking ten meters in a straight line for four minutes
- 4-week program; 3 days/week; Conventional Treatment: Exercises for range of motion, mobility and weight bearing, muscle stretching, static quadriceps exercise, quadriceps exercise, and straight leg raising
Muscle Energy TechniqueOther
The Muscle Energy Technique (MET) to strengthen and flex your quadriceps and hamstrings.
- After maintaining an isometric contraction for ten seconds, a little stretch was maintained for thirty seconds.
- Four contractions every treatment, separated by three seconds of rest. Standing with feet parallel for one minute*2, standing on one leg's forefoot and the other leg's heel for two seconds*2, standing on the forefoot for three seconds*15
- Move in a 10 m by 4 straight line.
- 4-week program; 3 days/week Conventional Treatment: Exercises for range of motion, mobility and weight bearing, muscle stretching, static quadriceps exercise, quadriceps exercise, and straight leg raising
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Strength Training | Experimental | Group of TKR patients are given high intensity strength training. Receives: Other: High Intensity Strength Training |
| Muscle Energy Technique Exercises | Active comparator | patients are given muscle energy technique exercise. Receives: Other: Muscle Energy Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROM
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.
Measured: 4th week
Functional Status: Knee Injury and Osteoarthritis outcome score
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.
Measured: 4th week
Pain : Numeric Pain Rating Scale
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.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start30 Jan 2025
- Primary completion15 May 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Amna Tariq, DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407778
- Sponsor's protocol ID
- REC/RCR&AHS/23/01104
- Status last verified
- Jul 2025
- First submitted
- 6 May 2024
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 37715204Casana 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.
PubMed 30361758Irrgang 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.
PubMed 9730122Bade 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.
PubMed 21979411
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of High Intensity Strength Training and Muscle Energy Technique on Pain, ROM and Functional Status in Patients With Total Knee Replacement
- ClinicalTrials.gov ID
- NCT06407778
- Acronym / sponsor ID
- REC/RCR&AHS/23/01104
- Keywords
- Total Knee Replacement, Knee Osteoarthritis, Strength Training, Muscle Energy Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 9 May 2024 (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.
Globally, the prevalence of total joint replacement (TKR) procedures has been rising, providing patients with better joint function, decreased pain, and enhanced quality of life. A thorough and successful postoperative rehabilitation program, which attempts to restore optimal function and lower the risk of problems related to the treatment, is necessary for the success of total knee replacement (TKR) procedures. After total knee replacement, postoperative rehabilitation is a crucial stage in the patient's healing process. Normal knee function is frequently hampered by issues like pain management, muscular weakness, joint stiffness, and proprioceptive deficiencies. Therefore, choosing a suitable rehabilitation regimen is crucial.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Strength Training | Experimental | Other: High Intensity Strength TrainingGroup of TKR patients are given high intensity strength training. |
| Muscle Energy Technique Exercises | Active comparator | Other: Muscle Energy Techniquepatients are given muscle energy technique exercise. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| High Intensity Strength Training* High-intensity workouts to strengthen the quadriceps and enhance knee function; * Knee flexion and extension 10 lbs. * 10RM of hip flexion and extension * 10RM hip adduction and abduction * Standing with feet aligned for one minute*2, standing on one leg's forefoot and the other leg's heel for two minutes*2, standing on one foot for three seconds*15, and walking ten meters in a straight line for four minutes * 4-week program; 3 days/week; Conventional Treatment: Exercises for range of motion, mobility and weight bearing, muscle stretching, static quadriceps exercise, quadriceps exercise, and straight leg raising | Other | High Intensity Strength Training |
| Muscle Energy TechniqueThe Muscle Energy Technique (MET) to strengthen and flex your quadriceps and hamstrings. * After maintaining an isometric contraction for ten seconds, a little stretch was maintained for thirty seconds. * Four contractions every treatment, separated by three seconds of rest. Standing with feet parallel for one minute*2, standing on one leg's forefoot and the other leg's heel for two seconds*2, standing on the forefoot for three seconds*15 * Move in a 10 m by 4 straight line. * 4-week program; 3 days/week Conventional Treatment: Exercises for range of motion, mobility and weight bearing, muscle stretching, static quadriceps exercise, quadriceps exercise, and straight leg raising | Other | Muscle Energy Technique Exercises |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Background: PubMed 37715204Sun 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.
- Background: PubMed 30361758Casana 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.
- Background: PubMed 9730122Irrgang 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.
- Background: PubMed 21979411Bade 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.
- 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. This study is not recruiting at the moment.
Hafiza Amna Tariq, DPT principal investigator
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 High Intensity Strength Training and Muscle Energy Technique in people with Knee Osteoarthritis and Arthroplasty, 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 4 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 4 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?
ROM (time frame: 4th week). The study lists 3 primary outcomes in all. 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 NCT06407778, which also lists 4 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 4 Jul 2025.