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

NCT ID: NCT04831411

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2022-07-08

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.

Conditions

Knee Arthropathy

Study Design

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

Study Groups

Whole Body Vibration

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.

Group Type: ACTIVE_COMPARATOR

Total Knee Arthroplasty

Intervention Type: 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.

Whole Body Vibration

Intervention Type: OTHER

Whole Body Vibration

Progressive Resistance Training

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.

Group Type: ACTIVE_COMPARATOR

Total Knee Arthroplasty

Intervention Type: 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

Intervention Type: OTHER

Progressive Resistance Training

Interventions

Total Knee Arthroplasty

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.

Intervention Type: PROCEDURE

Whole Body Vibration

Whole Body Vibration

Intervention Type: OTHER

Progressive Resistance Training

Progressive Resistance Training

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Gökhan Bayrak

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gökhan Bayrak

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

Gökhan Bayrak

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 20397856 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31703305 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26763947 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25525066 (View on PubMed)

Other Identifiers

WBV-PRE training after TKA

Identifier Type: -

Identifier Source: org_study_id