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

NCT05618015 | Completed DMC

• 1 other identifier: 60116787-020/49018/13
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• The Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

  8 weeks

• Fortgotten Joint Score-12 (FJS-12)

  8 weeks

• World Health Organization Quality of Life Instrument Short Form (WHOQOL-BREF)

  8 weeks

Study Arms (2)

Supervised progressive resistance training

EXPERIMENTAL

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

Procedure: Supervised progressive resistance training

Home-based progressive resistance training

ACTIVE COMPARATOR

Home-based PRT was conducted at home without supervision

Procedure: Home-based progressive resistance training

Interventions

Supervised progressive resistance training PROCEDURE

Exercises were performed with cable resistance training machine

Supervised progressive resistance training

Home-based progressive resistance training 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.

Home-based progressive resistance training

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

Related 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/acr.22405.

  PMID: 25074397 RESULT

• 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.

  PMID: 27584144 RESULT

• 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.

  PMID: 25961017 RESULT

Study Officials

• Gökhan BAYRAK, PhD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, it is not possible to blind participants or the treating physiotherapist. To reduce the bias risk, the outcome assessor was blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 16, 2022
• Study Start: July 16, 2019
• Primary Completion: June 3, 2021
• Study Completion: June 25, 2021
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)