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

Primary Purpose

Knee Arthropathy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Total Knee Arthroplasty
Whole Body Vibration
Progressive Resistance Training
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthropathy focused on measuring fast-track surgery, whole body vibration, progressive resistance training, total knee arthroplasty, rehabilitation

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gökhan Bayrak

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Whole Body Vibration

Progressive Resistance Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Pain assesment
Pain will be assessed by the Visual Pain Scale (pain perceived during rest, sleep and walking).
Western Ontario and McMaster Universities Osteoarthritis Index score
Western Ontario and McMaster Universities Osteoarthritis Index score is a patient-reported questionnaire that evaluates pain, stiffness, and physical function in patients with hip and knee OA. The index consists of 24 questions and the scores of the questions range from 0 (none) to 4 (very severe) and the results are evaluated over 100 points (minimum score:0 and the maximum score:100). Higher scores indicate worst knee functions.
Quality of life measure
Short form-36 will be used for quality of life assessment. SF-36 is a patient-reported questionnaire developed and made available to determine health-related quality of life. SF-36 consists of 36 items that measure eight dimensions of physical function, social function, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/vitality, pain and general health perception. The subscales assess health between 0 and 100, with 0 showing bad health and 100 showing better health. Higher scores indicate better quality of life.
40 m fast-paced walk test
Patients will be asked to walk along the 10-meter track as fast as possible, turn around the cone at the finish, and complete the 40-meter total distance. After the patient passed the baseline in the last stage, the time will be stopped and the total time will be recorded. Lower walking distance indicates better walking capacity.
Sit-to-stand test
The patient will be seated in the middle of a chair with a height of standard 44 cm, with his back straight, arms crossed in front of his chest, and feet on the ground. The patient will be asked to get up from the chair and sit down as much as the patient could for 30 seconds. The exact number of starts will be made formed from the patient's score. Higher scores indicate better overall strength.
Stair climbing test
The patient will be asked to climb and descend the 9-step 16-20 centimetre ladder as quickly but safely as possible. The patient will be allowed to use a handrail or a walking aid, and the method used was recorded. The test will start with the start command and the time stopped when the patient returned to the starting place. The patient will be allowed to stop and rest when requested, but the duration will be continued. The total time was recorded as a score. Lower scores indicate better knee functions.
Timed up and go test
Timed up and go test (TUG) is a measurement that evaluates functional mobility, dynamic balance, fall risk and postural stability, which can be applied for different purposes in different age and patient groups. The activities that make up the test evaluate the transition from sitting to standing position, walking, turning, and sitting again, which are necessary for functional mobility and dynamic balance. The TUG test measures the time it takes an individual to get up from a standard chair with armrests and walk a distance of 3 meters, return from a designated or marked place, return to the chair, and sit down again. Lower scores indicate better mobility and balance.

Full Information

First Posted
April 1, 2021
Last Updated
March 27, 2023
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04831411
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
July 8, 2022 (Actual)
Study Completion Date
July 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy
Keywords
fast-track surgery, whole body vibration, progressive resistance training, total knee arthroplasty, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole Body Vibration
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Progressive Resistance Training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Total Knee Arthroplasty
Intervention Description
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
Other
Intervention Name(s)
Whole Body Vibration
Intervention Description
Whole Body Vibration
Intervention Type
Other
Intervention Name(s)
Progressive Resistance Training
Intervention Description
Progressive Resistance Training
Primary Outcome Measure Information:
Title
Balance
Description
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.
Time Frame
6 weeks
Title
Quadriceps muscle strength
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Pain assesment
Description
Pain will be assessed by the Visual Pain Scale (pain perceived during rest, sleep and walking).
Time Frame
6 weeks
Title
Western Ontario and McMaster Universities Osteoarthritis Index score
Description
Western Ontario and McMaster Universities Osteoarthritis Index score is a patient-reported questionnaire that evaluates pain, stiffness, and physical function in patients with hip and knee OA. The index consists of 24 questions and the scores of the questions range from 0 (none) to 4 (very severe) and the results are evaluated over 100 points (minimum score:0 and the maximum score:100). Higher scores indicate worst knee functions.
Time Frame
6 weeks
Title
Quality of life measure
Description
Short form-36 will be used for quality of life assessment. SF-36 is a patient-reported questionnaire developed and made available to determine health-related quality of life. SF-36 consists of 36 items that measure eight dimensions of physical function, social function, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/vitality, pain and general health perception. The subscales assess health between 0 and 100, with 0 showing bad health and 100 showing better health. Higher scores indicate better quality of life.
Time Frame
6 weeks
Title
40 m fast-paced walk test
Description
Patients will be asked to walk along the 10-meter track as fast as possible, turn around the cone at the finish, and complete the 40-meter total distance. After the patient passed the baseline in the last stage, the time will be stopped and the total time will be recorded. Lower walking distance indicates better walking capacity.
Time Frame
6 weeks
Title
Sit-to-stand test
Description
The patient will be seated in the middle of a chair with a height of standard 44 cm, with his back straight, arms crossed in front of his chest, and feet on the ground. The patient will be asked to get up from the chair and sit down as much as the patient could for 30 seconds. The exact number of starts will be made formed from the patient's score. Higher scores indicate better overall strength.
Time Frame
6 weeks
Title
Stair climbing test
Description
The patient will be asked to climb and descend the 9-step 16-20 centimetre ladder as quickly but safely as possible. The patient will be allowed to use a handrail or a walking aid, and the method used was recorded. The test will start with the start command and the time stopped when the patient returned to the starting place. The patient will be allowed to stop and rest when requested, but the duration will be continued. The total time was recorded as a score. Lower scores indicate better knee functions.
Time Frame
6 weeks
Title
Timed up and go test
Description
Timed up and go test (TUG) is a measurement that evaluates functional mobility, dynamic balance, fall risk and postural stability, which can be applied for different purposes in different age and patient groups. The activities that make up the test evaluate the transition from sitting to standing position, walking, turning, and sitting again, which are necessary for functional mobility and dynamic balance. The TUG test measures the time it takes an individual to get up from a standard chair with armrests and walk a distance of 3 meters, return from a designated or marked place, return to the chair, and sit down again. Lower scores indicate better mobility and balance.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gökhan Bayrak
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gökhan Bayrak
City
Denizli
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20397856
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.
Results Reference
background
PubMed Identifier
31703305
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.
Results Reference
background
PubMed Identifier
26763947
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.
Results Reference
background
PubMed Identifier
25525066
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.
Results Reference
background

Learn more about this trial

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

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