Clinical trial NCT04831411: Comparison of Early Whole Body Vibration and Progressive Resistance Training in Fast-Track Total Knee Arthroplasty.
Official title: Comparison of Early Whole Body Vibration and Progressive Resistance Training to Enhance Recovery After Fast-Track Total Knee Arthroplasty: A Randomized Comparative Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthropathy
Keywords: fast-track surgery
whole body vibration
progressive resistance training
total knee arthroplasty
rehabilitation
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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. After 2 days and 6 weeks of training a week, final evaluations will be made at the end of the 10th postoperative week. Evaluations will include measures of impairment in body functions and structures, activity limitation measures, balance assessment, and quality of life assessments. Evaluations will be made by a blind researcher. The study will be started with a total of 28 patients, including 14 participants in both groups. The sample size was determined by performing a power analysis. The purpose of the study will be explained to the patients by the researcher and the patients who agree to participate in the planned study will be included in the study.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Balance
timeFrame: 6 weeks
measure: Quadriceps muscle strength
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain assesment
timeFrame: 6 weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index score
timeFrame: 6 weeks
measure: Quality of life measure
timeFrame: 6 weeks
measure: 40 m fast-paced walk test
timeFrame: 6 weeks
measure: Sit-to-stand test
timeFrame: 6 weeks
measure: Stair climbing test
timeFrame: 6 weeks
measure: Timed up and go test
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Gökhan Bayrak
Study officials:
affiliation: Pamukkale University
name: Gökhan Bayrak
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.