NCT06407778

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2025

Completed
Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

May 6, 2024

Last Update Submit

July 3, 2025

Conditions

Keywords

Total Knee ReplacementKnee OsteoarthritisStrength TrainingMuscle Energy Technique

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    4th week

Study Arms (2)

High Intensity Strength Training

EXPERIMENTAL

Group of TKR patients are given high intensity strength training.

Other: High Intensity Strength Training

Muscle Energy Technique Exercises

ACTIVE COMPARATOR

patients are given muscle energy technique exercise.

Other: Muscle Energy Technique

Interventions

* 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

High Intensity Strength Training

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

Muscle Energy Technique Exercises

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Horizon Hospital Lahore

Lahore, Punjab Province, 05450, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 37715204BACKGROUND
  • 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.

    PMID: 30361758BACKGROUND
  • 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.

    PMID: 9730122BACKGROUND
  • 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.

    PMID: 21979411BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Hafiza Amna Tariq, DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
outcome Assessor will be blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

January 30, 2025

Primary Completion

May 15, 2025

Study Completion

June 12, 2025

Last Updated

July 4, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations