Vibration Applications After Total Knee Arthroplasty in Osteopenic Women
NCT ID: NCT06988033
Last Updated: 2025-11-17
Study Results
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Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2025-08-01
2025-12-05
Brief Summary
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Following TKA, bone mineral density (BMD) tends to decrease during the first three months. The reduction in BMD and the increase in bone resorption may elevate the risk of implant loosening or periprosthetic fracture. Bone turnover markers (BTMs), which are enzymes or degradation products released into circulation by bone cells, reflect bone remodeling processes and can help identify increased fracture risk.
A significant proportion of TKA candidates are osteopenic. Since osteopenic individuals make up a larger segment of the population, most fragility fractures actually occur in individuals with osteopenia rather than osteoporosis. Therefore, BMD levels and the presence of osteopenia or osteoporosis should be taken into account in patients undergoing TKA.
To preserve both bone quality and muscle mass, early rehabilitation and progressive weight-bearing on the operated limb are considered essential. These strategies may improve both BMD and BTMs. Whole-body vibration (WBV) therapy has been suggested as an effective and safe method to increase mechanical loading on the bones. WBV can be applied in a static standing position on a vibration platform or combined with simultaneous exercise.
Given the limited availability of targeted strategies to improve bone remodeling and BTMs after TKA, and the lack of clarity regarding the optimal WBV protocol, this study aims to investigate the effects of different vibration applications on bone turnover markers, functionality, muscle strength, pain intensity, pressure pain threshold, range of motion, proprioception, edema, and muscle biomechanical properties in osteopenic women following TKA.
Participants will be randomly assigned to one of three groups: WBV only, WBV combined with exercise (WBV-E), or control. All groups will receive traditional rehabilitation three times per week for four weeks after surgery. WBV interventions will begin at the end of the fourth postoperative week, once patients are deemed ready. While WBV groups will receive additional vibration therapy, the control group will continue traditional rehabilitation alone.
Outcomes will be evaluated using bone turnover markers, the Timed Up and Go (TUG) test, the 30-Second Chair Stand Test, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), measurements of muscle biomechanical properties and strength, pain intensity and pressure pain threshold, joint range of motion, proprioception, and edema.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Whole Body Vibration
Participants in this group will receive whole body vibration (WBV) in addition to the standard postoperative rehabilitation program. WBV will be applied 3 times per week. In the first week, 1 set of 5-minute static standing WBV will be administered at a low frequency (8 Hz) and amplitude (2 mm). In subsequent weeks, progression will be applied based on participant tolerance. The frequency will increase gradually up to 30-40 Hz, and the amplitude up to 5 mm, with a total WBV duration of up to 15 minutes per session. Participants will stand upright with equal weight distribution on both feet during vibration. No concurrent exercise will be performed during WBV.
Whole Body Vibration Therapy
Participants receive whole-body vibration therapy in a static upright position on a vibration platform (Power Plate My5). The intervention is applied 3 times per week for 8 weeks, progressively increasing frequency from 8 Hz to 40 Hz and amplitude from 2 mm to 5 mm. Each session lasts up to 15 minutes. No exercise is performed during the vibration.
Whole Body Vibration with Exercise (WBV-E)
In this group, participants will receive whole body vibration (WBV) simultaneously with lower extremity exercises performed on a vibrating platform. After exercise training is demonstrated on a stable surface, participants will perform the exercises on the platform. WBV will be initiated with low amplitude (2 mm) for the first two weeks and increased to 5 mm by the third week depending on pain tolerance. Frequency will be maintained between 30-40 Hz. Exercises will include lunge steps, shallow squats, dynamic squats, toe raises, and ball squeezes between the knees (2-3 kg medicine ball). Vibration duration will progress from 2 minutes (3 exercises × 30 sec) to a maximum of 18 minutes (6 exercises × 60 sec × 3 sets). One-minute rest will be provided between sets and repetitions. Total session duration will vary between 45 and 70 minutes.
Whole Body Vibration with Exercise
Participants perform lower extremity strengthening exercises on a vibration platform simultaneously with whole-body vibration. The protocol includes lunges, squats, heel raises, and ball squeezes. Vibration frequency ranges from 30 to 40 Hz and amplitude from 2 to 5 mm. Sessions are performed 3 times per week for 8 weeks, with duration progressing from 2 to 18 minutes depending on tolerance.
Control
Participants in this group will receive only the standard postoperative rehabilitation program and an individualized home exercise plan. The conventional rehabilitation protocol includes exercises with rest periods of 1 minute between sets and repetitions. The average initial session duration will be approximately 45 minutes, progressing to 60-70 minutes in later sessions. No vibration intervention will be administered.
Conventional Physiotherapy
Participants receive standard post-total knee arthroplasty physiotherapy 3 times per week for 12 weeks, lasting 40 to 70 minutes per session. In addition, a home-based exercise program is performed 3 times daily. The program includes range of motion, strengthening, and balance exercises. No vibration therapy is applied in this group.
Interventions
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Whole Body Vibration Therapy
Participants receive whole-body vibration therapy in a static upright position on a vibration platform (Power Plate My5). The intervention is applied 3 times per week for 8 weeks, progressively increasing frequency from 8 Hz to 40 Hz and amplitude from 2 mm to 5 mm. Each session lasts up to 15 minutes. No exercise is performed during the vibration.
Whole Body Vibration with Exercise
Participants perform lower extremity strengthening exercises on a vibration platform simultaneously with whole-body vibration. The protocol includes lunges, squats, heel raises, and ball squeezes. Vibration frequency ranges from 30 to 40 Hz and amplitude from 2 to 5 mm. Sessions are performed 3 times per week for 8 weeks, with duration progressing from 2 to 18 minutes depending on tolerance.
Conventional Physiotherapy
Participants receive standard post-total knee arthroplasty physiotherapy 3 times per week for 12 weeks, lasting 40 to 70 minutes per session. In addition, a home-based exercise program is performed 3 times daily. The program includes range of motion, strengthening, and balance exercises. No vibration therapy is applied in this group.
Eligibility Criteria
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Inclusion Criteria
* Ability to speak and understand Turkish
* Ability to comprehend both verbal and written information
* A T-score between -2.5 and -1 (i.e., -2.5 \< T-score \< -1) measured by DXA in the lumbar spine, total hip, or femoral neck within the past year
Exclusion Criteria
* American Society of Anesthesiologists (ASA) physical status classification score higher than 3
* History of major surgery on the limb to be operated
* Presence of comorbid diseases such as rheumatoid arthritis or cancer
* Presence of a neurological condition causing functional impairment
* Diagnosed psychiatric disorder
* Dementia
* Disorders affecting the vestibular system
* Having undergone anesthesia for any reason within the last month
* Regular use of hypnotic or anxiolytic medications
* Hearing or vision impairment not correctable by hearing aids or glasses
* Presence of endocrine system disorders
* Secondary osteoporosis or history of osteoporotic fracture
* Metabolic bone diseases or chronic illnesses potentially affecting bone metabolism
* Use of medications known to affect bone metabolism (e.g., menopausal hormone therapy, bisphosphonates, raloxifene, calcitonin, growth hormone, parathyroid hormones, corticosteroids) within 6 months prior to the start of the study
60 Years
75 Years
FEMALE
No
Sponsors
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Istinye University
OTHER
Responsible Party
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Principal Investigators
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GÜL DENİZ YILMAZ YELVAR, ASSOCIATE PROFESSOR
Role: STUDY_CHAIR
Istinye University
Locations
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Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul, Uskudar, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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He Z, Zheng J, Liu S, Guan Z, Zhou Q, Jin X, Guan Z. The effect of whole-body vibration in osteopenic patients after total knee arthroplasty: a randomized controlled trial. Aging Clin Exp Res. 2022 Jun;34(6):1381-1390. doi: 10.1007/s40520-021-02043-2. Epub 2022 Jan 14.
Gazdzik TS, Gajda T, Kaleta M. Bone mineral density changes after total knee arthroplasty: one-year follow-up. J Clin Densitom. 2008 Jul-Sep;11(3):345-50. doi: 10.1016/j.jocd.2008.04.007. Epub 2008 Jul 10.
Cardinale M, Bosco C. The use of vibration as an exercise intervention. Exerc Sport Sci Rev. 2003 Jan;31(1):3-7. doi: 10.1097/00003677-200301000-00002.
Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
Klug A, Gramlich Y, Rudert M, Drees P, Hoffmann R, Weissenberger M, Kutzner KP. The projected volume of primary and revision total knee arthroplasty will place an immense burden on future health care systems over the next 30 years. Knee Surg Sports Traumatol Arthrosc. 2021 Oct;29(10):3287-3298. doi: 10.1007/s00167-020-06154-7. Epub 2020 Jul 15.
Sowers M. Epidemiology of risk factors for osteoarthritis: systemic factors. Curr Opin Rheumatol. 2001 Sep;13(5):447-51. doi: 10.1097/00002281-200109000-00018.
Other Identifiers
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IstinyeUni-EALOGLUCIFTCI-001
Identifier Type: -
Identifier Source: org_study_id
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