Clinical trial NCT05618015: Comparison of the Supervised and Home-Based Progressive Resistant Training in Female Total Knee Arthroplasty Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 32
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Quadriceps and hip abductor muscles strength
timeFrame: 8 weeks
measure: 30s sit-to-stand test
timeFrame: 8 weeks
measure: 40m fast-paced walk test
timeFrame: 8 weeks
measure: Stair climbing test
timeFrame: 8 weeks
measure: Knee range of motion (ROM)
timeFrame: 8 weeks
measure: Knee pain: Visual Analogy Scale (VAS)
timeFrame: 8 weeks
Secondary outcomes:
measure: The Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
timeFrame: 8 weeks
measure: Fortgotten Joint Score-12 (FJS-12)
timeFrame: 8 weeks
measure: World Health Organization Quality of Life Instrument Short Form (WHOQOL-BREF)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Gökhan BAYRAK, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. 2017 Jun;96(6):440-447. doi: 10.1097/PHM.0000000000000621.
citation: 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.