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

NCT ID: NCT05618015

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-16
• Study Completion Date: 2021-06-25

Brief 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.

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).

Conditions

Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Supervised progressive resistance training

Supervised PRT was conducted face-to-face at the clinic

Group Type: EXPERIMENTAL

Supervised progressive resistance training

Intervention Type: PROCEDURE

Exercises were performed with cable resistance training machine

Home-based progressive resistance training

Home-based PRT was conducted at home without supervision

Group Type: ACTIVE_COMPARATOR

Home-based progressive resistance training

Intervention Type: PROCEDURE

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.

Interventions

Supervised progressive resistance training

Exercises were performed with cable resistance training machine

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

UMMUHAN BAS ASLAN

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gökhan BAYRAK, PhD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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/acr.22405.

Reference Type: RESULT

PMID: 25074397 (View on PubMed)

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. 2017 Jun;96(6):440-447. doi: 10.1097/PHM.0000000000000621.

Reference Type: RESULT

PMID: 27584144 (View on PubMed)

Lopez-Liria R, Padilla-Gongora D, Catalan-Matamoros D, Rocamora-Perez P, Perez-de la Cruz S, Fernandez-Sanchez M. Home-Based versus Hospital-Based Rehabilitation Program after Total Knee Replacement. Biomed Res Int. 2015;2015:450421. doi: 10.1155/2015/450421. Epub 2015 Apr 16.

Reference Type: RESULT

PMID: 25961017 (View on PubMed)

Other Identifiers

60116787-020/49018/13

Identifier Type: -

Identifier Source: org_study_id