Knee ArthropathyNCT04831411
Comparison of Early Whole Body Vibration and Progressive Resistance Training in Fast-Track Total Knee Arthroplasty.
A study testing Total Knee Arthroplasty, Whole Body Vibration and Progressive Resistance Training in people with Knee Arthropathy, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- Total Knee Arthroplasty, Whole Body Vibration and Progressive Resistance Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2021to 8 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- Total Knee Arthroplasty, Whole Body Vibration, Progressive Resistance Training
- Keywords
- fast-track surgery, whole body vibration, progressive resistance training, total knee arthroplasty, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
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 VibrationOther
Whole Body Vibration
Progressive Resistance TrainingOther
Progressive Resistance Training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Total Knee Arthroplasty; Other: Progressive Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (7)
Pain assesment
Pain will be assessed by the Visual Pain Scale (pain perceived during rest, sleep and walking).
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start4 Jan 2021
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan Bayrak, Pamukkale University
- Investigators
- Gökhan Bayrak, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831411
- Sponsor's protocol ID
- WBV-PRE training after TKA
- Status last verified
- Mar 2023
- First submitted
- 1 Apr 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20397856Hsiao 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.
PubMed 31703305Bily 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.
PubMed 26763947Wang 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.
PubMed 25525066
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04831411
- Acronym / sponsor ID
- WBV-PRE training after TKA
- Conditions
- Knee Arthropathy
- Keywords
- fast-track surgery, whole body vibration, progressive resistance training, total knee arthroplasty, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration | Active comparator | Procedure: Total Knee Arthroplasty, Other: Whole Body VibrationThe 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. |
| Progressive Resistance Training | Active comparator | Procedure: Total Knee Arthroplasty, Other: Progressive Resistance TrainingThe 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee ArthroplastyThe 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. | Procedure or surgery | Progressive Resistance Training, Whole Body Vibration |
| Whole Body VibrationWhole Body Vibration | Other | Whole Body Vibration |
| Progressive Resistance TrainingProgressive Resistance Training | Other | Progressive Resistance Training |
Primary outcome
Balance
Time frame: 6 weeks
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
Time frame: 6 weeks
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.
7 secondary outcomes
Pain assesment
Time frame: 6 weeks
Western Ontario and McMaster Universities Osteoarthritis Index score
Time frame: 6 weeks
Quality of life measure
Time frame: 6 weeks
40 m fast-paced walk test
Time frame: 6 weeks
Sit-to-stand test
Time frame: 6 weeks
Stair climbing test
Time frame: 6 weeks
Timed up and go test
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Background: PubMed 20397856Johnson 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.
- Background: PubMed 31703305Hsiao 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.
- Background: PubMed 26763947Bily 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.
- Background: PubMed 25525066Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gökhan Bayrak principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Arthroplasty, Whole Body Vibration and Progressive Resistance Training in people with Knee Arthropathy, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04831411, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.