Comparison of Early Whole Body Vibration and Progressive Resistance Training in Fast-Track Total Knee Arthroplasty.

NCT04831411 | Completed DMC

• 1 other identifier: WBV-PRE training after TKA
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who have undergone total knee arthroplasty (TKA) with Fast-Track recovery protocol at the Department of Orthopedics and Traumatology at the Local University Hospital and meet the inclusion and exclusion criteria will constitute the study sample. The patients will be divided into 2 groups using the computerized randomization method in the post-operative 4th week; Whole Body Vibration Group and Progressive Resistance Exercise Group. The first evaluation of the participants will be made at the end of the post-operative 4th week. Final evaluations will be made at the end of the post-operative 10th week, following the 6-week training.

Conditions

Knee Arthropathy

Keywords

fast-track surgery; whole body vibration; progressive resistance training; total knee arthroplasty; rehabilitation

Outcome Measures

Primary Outcomes (2)

• Balance

  Kinesthetic Ability Trainer® (KAT Model TS 650) will be used to evaluate balance. Patients will use the lines on the platform to place their feet in the same place for each measurement. Patients will be informed that the cursor on the system interface indicating the location of the pressure centre should be moved as little as possible and kept close to the centre. The rates of pressure centre change will be recorded as a result of the balance score obtained after 30 seconds of measurements on bipedal feet. Measurements will be applied in 3 repetitions and their average will be recorded and recorded in the study.

  6 weeks

• Quadriceps muscle strength

  A handheld dynamometer (Commander Muscle Tester, JTech, USA) will be used for quadriceps muscle strength measurement. Patients will be seated on the treatment table with their hips and knees in 90 ° flexion with their feet hanging down. In this position, the hands will be on crossed shoulders and the use of bodyweight will be prevented. During the measurements, verbal guidance will be given to the patients in order to achieve maximum effort. Measurements will be made from the distal anterior face of the tibia with 3 consecutive maximum isometric contractions. The average of the measurement values will be recorded as a score.

  6 weeks

Secondary Outcomes (7)

• Pain assesment

  6 weeks

• Western Ontario and McMaster Universities Osteoarthritis Index score

  6 weeks

• Quality of life measure

  6 weeks

• 40 m fast-paced walk test

  6 weeks

• Sit-to-stand test

  6 weeks

Study Arms (2)

Whole Body Vibration

ACTIVE COMPARATOR

The training program will last 2 days a week and 6 weeks in total. Each session includes a warm-up, progressive whole-body vibration training and a cooling exercise. On the remaining days of the week, all patients will apply the standard exercise program, which includes simple home exercises, at home.

Procedure: Total Knee Arthroplasty; Other: Whole Body Vibration

Progressive Resistance Training

ACTIVE COMPARATOR

The training program will last 2 days a week and 6 weeks in total. Each session includes a warm-up, progressive resistance training and a cooling exercise. On the remaining days of the week, all patients will apply the standard exercise program, which includes simple home exercises, at home.

Procedure: Total Knee Arthroplasty; Other: Progressive Resistance Training

Interventions

Total Knee Arthroplasty PROCEDURE

The extremities of patients admitted to the operating room to be applied TKA will be determined using a safe surgical Fast-Track recovery protocol. Patients will be operated by the same surgical team using the same technique. Spinal anaesthesia or general anaesthesia will be applied to the patients according to the evaluations of the anesthesiologists.

Progressive Resistance Training; Whole Body Vibration

Whole Body Vibration OTHER

Whole Body Vibration

Whole Body Vibration

Progressive Resistance Training OTHER

Progressive Resistance Training

Progressive Resistance Training

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing unilateral TKA surgery due to knee OA,
• Being between the ages of 50-75,
• To be able to understand the verbal and written information given.

You may not qualify if:

• To undergo revision TKA surgery.
• Participating in any exercise or strengthening training within the last 3 months.
• Having undergone major surgery on the extremity to be operated on.
• Having a comorbid disease such as rheumatoid arthritis, cancer.
• Having a neurological disease that causes functional insufficiency.
• Having a diagnosed psychiatric disorder.
• Having received anaesthesia for any reason in the last 1 month.
• Regularly using hypnotics or anxiolytics.
• Having dementia.
• Having a hearing or vision impairment that cannot be corrected with a hearing aid or glasses.
• Being morbidly obese (Body mass index\> 40 kg/m2).
• Having implanted pacemakers or defibrillators.
• Having dermatological problems affecting the thigh.
• Having a score above 3 in the American Society of Anesthesiologists classification score.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Gökhan Bayrak

Denizli, Turkey (Türkiye)

Location

Related Publications (4)

• Johnson AW, Myrer JW, Hunter I, Feland JB, Hopkins JT, Draper DO, Eggett D. Whole-body vibration strengthening compared to traditional strengthening during physical therapy in individuals with total knee arthroplasty. Physiother Theory Pract. 2010 May;26(4):215-25. doi: 10.3109/09593980902967196.

  PMID: 20397856 BACKGROUND

• Hsiao YH, Chien SH, Tu HP, Fu JC, Tsai ST, Chen YS, Chen YJ, Chen CH. Early Post-Operative Intervention of Whole-Body Vibration in Patients After Total Knee Arthroplasty: A Pilot Study. J Clin Med. 2019 Nov 7;8(11):1902. doi: 10.3390/jcm8111902.

  PMID: 31703305 BACKGROUND

• Bily W, Franz C, Trimmel L, Loefler S, Cvecka J, Zampieri S, Kasche W, Sarabon N, Zenz P, Kern H. Effects of Leg-Press Training With Moderate Vibration on Muscle Strength, Pain, and Function After Total Knee Arthroplasty: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Jun;97(6):857-65. doi: 10.1016/j.apmr.2015.12.015. Epub 2016 Jan 4.

  PMID: 26763947 BACKGROUND

• Wang P, Yang X, Yang Y, Yang L, Zhou Y, Liu C, Reinhardt JD, He C. Effects of whole body vibration on pain, stiffness and physical functions in patients with knee osteoarthritis: a systematic review and meta-analysis. Clin Rehabil. 2015 Oct;29(10):939-51. doi: 10.1177/0269215514564895. Epub 2014 Dec 18.

  PMID: 25525066 BACKGROUND

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Gökhan Bayrak

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: January 4, 2021
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)