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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05618015
• Other study ID #: 60116787-020/49018/13
• Status: Completed
• Phase: N/A
• Start date: July 16, 2019
• Est. completion date: June 25, 2021

Study information

• Verified date: November 2022
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 25, 2021
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Procedure:
• Supervised progressive resistance training
Exercises were performed with cable resistance training machine
• 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.

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Jakobsen TL, Kehlet H, Husted H, Petersen J, Bandholm T. Early progressive strength training to enhance recovery after fast-track total knee arthroplasty: a randomized controlled trial. Arthritis Care Res (Hoboken). 2014 Dec;66(12):1856-66. doi: 10.1002/a — View Citation

Li D, Yang Z, Kang P, Xie X. Home-Based Compared with Hospital-Based Rehabilitation Program for Patients Undergoing Total Knee Arthroplasty for Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Am J Phys Med Rehabil. 2 — View Citation

López-Liria R, Padilla-Góngora D, Catalan-Matamoros D, Rocamora-Pérez P, Pérez-de la Cruz S, Fernández-Sánchez M. Home-Based versus Hospital-Based Rehabilitation Program after Total Knee Replacement. Biomed Res Int. 2015;2015:450421. doi: 10.1155/2015/450 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadriceps and hip abductor muscles strength	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
Primary	30s sit-to-stand test	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
Primary	40m fast-paced walk test	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
Primary	Stair climbing test	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
Primary	Knee range of motion (ROM)	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
Primary	Knee pain: Visual Analogy Scale (VAS)	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	The Western Ontario and McMaster University Osteoarthritis Index (WOMAC)	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
Secondary	Fortgotten Joint Score-12 (FJS-12)	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
Secondary	World Health Organization Quality of Life Instrument Short Form (WHOQOL-BREF)	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