Comparison of the Supervised and Home-Based Progressive Resistant Training in Female Total Knee Arthroplasty Patients

November 15, 2022 updated by: UMMUHAN BAS ASLAN, Pamukkale University

Comparison of the Effectiveness of Supervised and Home-Based Progressive Resistant Training in the Mid-Term Postoperative Period in Female Total Knee Arthroplasty Patients

Early postoperative rehabilitation programs after TKA aims to provide optimal functional recovery. The current rehabilitation process in TKA typically includes 2 to 3 months post-surgery, as the greatest declines in strength and functional performance occur immediately after surgery. Yet, the content, duration, and intensity of the rehabilitation programs for the reorganization of physical function after surgery have not yet been fully clarified. Whether home-based rehabilitation is comparable to supervised rehabilitation in the midterm period requires further research, as practices after TKA vary. The purpose of this study is to compare the effectiveness of supervised and home-based progressive resistance training (PRT) in the midterm postoperative period in female patients undergoing TKA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to compare the pain, quadriceps strength, knee function, joint awareness, and quality of life between supervised or home-based PRT at 3 months after the total knee arthroplasty.

The study design is a single-blinded randomized trial. Both groups received standard physiotherapy for three months. In the third month postoperatively, supervised and home-based PRE, which consisted of sixteen sessions of exercise lasting eight weeks initiated. The clinical outcomes were compared at baseline (third month postoperatively) and the fifth month postoperative.

The clinical outcomes consisted of pain, range of motion (ROM), quadriceps and hip abductor muscle strength, and WOMAC (Western Ontario and McMaster University Arthritis Index ) score. The performance-based activity limitation test consisted of the 30-second sit-to-stand test, the 40-meter fast-paced walk test and the 9-step stair climb test. Joint awareness was assessed with Forgotten Joint Score-12 (FJS12). The quality of life was evaluated with the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF).

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • being a woman between the ages of 50-70
  • underwent unilateral primary TKA surgery due to knee osteoarthritis three months ago
  • understanding verbal and written instructions

Exclusion Criteria:

  • revision TKA surgery
  • neurological disease
  • rheumatoid arthritis
  • psychiatric problems
  • severe limitation of knee ROM (knee flexion range < 90°)
  • regular hypnotic or anxiolytics usage
  • dementia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Supervised progressive resistance training
Supervised PRT was conducted face-to-face at the clinic
Procedure: Supervised progressive resistance training
Exercises were performed with cable resistance training machine
Active Comparator: Home-based progressive resistance training
Home-based PRT was conducted at home without supervision
Procedure: Home-based progressive resistance training
In the first session, with the help of a physiotherapist, strengthening exercises were shown and taught to the patients. Two weeks after the beginning of the home-based PRT program, patients were called to check whether they were doing the exercises in the home program correctly. After the checking for exercise training, the patients were called by phone every two weeks for follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadriceps and hip abductor muscles strength
Time Frame: 8 weeks
The muscle strength was assessed with a hand-held dynamometer. For the quadriceps muscle test, the patient was seated on the edge of a hard bed. The dynamometer was placed on the midline of the tibia 5 cm proximal to the lateral malleolus. The patient was asked to force his leg into extension by overcoming the resistance of the dynamometer. For measurement of hip abductors muscle strength, the patient was placed supine and the dynamometer was placed on the lateral side of the leg, 5 cm proximal to the lateral malleolus. The patient was asked to force his leg into extension by overcoming the resistance of the dynamometer. The quadriceps and hip abductor muscles' strength were assessed at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).
8 weeks
30s sit-to-stand test
Time Frame: 8 weeks
The total number of sit-to-stand repetitions completed in 30 seconds was recorded. 30s sit-to-stand test is a measurement of lower limb strength and endurance. 30s sit-to-stand test was assessed at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).
8 weeks
40m fast-paced walk test
Time Frame: 8 weeks
The 40m fast-paced walking test measures short-distance walking activities. 40m fast-paced walk test was assessed at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).
8 weeks
Stair climbing test
Time Frame: 8 weeks
Functional limitations specific to ascending stairs were assessed with timed stair climbing and descending using a standard 9 steps (16-20 cm). Participants were instructed to climb stairs safely as soon as possible. Stair climbing test was assessed at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).
8 weeks
Knee range of motion (ROM)
Time Frame: 8 weeks
The universal goniometer was used to measure active knee flexion and extension while the participants were sitting with their knees hanging down on the edge of a firm bed. Knee ROM was assessed at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).
8 weeks
Knee pain: Visual Analogy Scale (VAS)
Time Frame: 8 weeks
Knee pain intensity during rest and activity (walking, sitting-to-standing, climbing stairs) were measured using separate 10 cm pain rating scale, with zero representing no pain at all and 10 representing worst imaginable pain. Knee pain was evaluated at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time Frame: 8 weeks
WOMAC was used to assess knee functions. WOMAC is a patient-reported, lower extremity-specific questionnaire and includes 24 questions: 17 on physical function, 5 on pain, and 2 on stiffness. WOMAC was evaluated at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).
8 weeks
Fortgotten Joint Score-12 (FJS-12)
Time Frame: 8 weeks
Artificial joint awareness was evaluated with FJS-12. The FJS-12 is a patient-reported outcome scale designed to assess joint awareness in the hips and knees. A five-point Likert response format consisting of a total of 12 questions, with a raw score converted from zero to 100 points, is used. FJS-12 was evaluated at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).
8 weeks
World Health Organization Quality of Life Instrument Short Form (WHOQOL-BREF)
Time Frame: 8 weeks
Quality of life was evaluated with the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF). The WHOQOL-BREF questionnaire is a test used to evaluate the quality of life of healthy individuals and patients and consists of four subscales: physical health, psychological health, social relations and environmental areas. WHOQOL-BREF was evaluated at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: Gökhan BAYRAK, PhD, Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2019

Primary Completion (Actual)

June 3, 2021

Study Completion (Actual)

June 25, 2021

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 60116787-020/49018/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Total Knee Arthroplasty

Clinical Trials on Supervised progressive resistance training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe