OsteopeniaNCT06988033
Vibration Applications After Total Knee Arthroplasty in Osteopenic Women
A study testing Whole Body Vibration Therapy, Whole Body Vibration with Exercise and Conventional Physiotherapy in people with Osteopenia and Total Knee Arthroplasty, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis (OA) is a chronic degenerative disease characterized by the destruction of articular cartilage, leading to functional impairment of surrounding bone and soft tissues. It is a major global public health problem, with the knee joint being the most commonly affected site. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Osteopenia, Total Knee Arthroplasty
- What is being tested?
- Whole Body Vibration Therapy, Whole Body Vibration with Exercise and Conventional Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 5 Apr 2026
- 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 60 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo unilateral, primary, cemented total knee arthroplasty (TKA) using a posterior cruciate ligament-sacrificing technique and medial parapatellar approach due to knee osteoarthritis
- 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
Who cannot join
- Scheduled for revision TKA
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul, Uskudar, 34668
About this study
Official title: Effects of Different Vibration Applications on Bone Turnover Markers and Functionality After Total Knee Arthroplasty in Women With Osteopenia: A Randomized Controlled Trial
Osteoarthritis (OA) is a chronic degenerative disease characterized by the destruction of articular cartilage, leading to functional impairment of surrounding bone and soft tissues. It is a major global public health problem, with the knee joint being the most commonly affected site. Treatment modalities include exercise, diet, oral non-steroidal anti-inflammatory drugs (NSAIDs), intra-articular injections, and total knee arthroplasty (TKA). TKA is indicated in cases of severe pain, functional loss, deformity, and limited range of motion when conservative methods are no longer effective. However, some patients may continue to experience deformity and functional deficits after surgery. Postoperative quadriceps weakness and decreased functional capacity can negatively affect patient prognosis.
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.
Read more
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.
- Conditions
- Osteopenia, Total Knee Arthroplasty
- Being tested
- Whole Body Vibration Therapy, Whole Body Vibration with Exercise, Conventional Physiotherapy
- Keywords
- Total Knee Arthroplasty, Osteopenia, Vibration, Women, Bone Turnover Markers
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body Vibration TherapyBehavioural
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 ExerciseBehavioural
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 PhysiotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Whole Body Vibration | Experimental | 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. Receives: Behavioral: Whole Body Vibration Therapy |
| Whole Body Vibration with Exercise (WBV-E) | Experimental | 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. Receives: Behavioral: Whole Body Vibration with Exercise |
| Control | Active comparator | 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. Receives: Behavioral: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG) Test Score
This test evaluates functional mobility and performance-based activity limitation. Participants are instructed to stand up from a standardized chair (height: 44 cm; depth: 26 cm), walk 3 meters at a normal pace, turn around, return, and sit down. The time taken to complete the task is recorded. The TUG test is a valid and reliable indicator of physical function in individuals with knee osteoarthritis.
Measured: Baseline (Week 4 post-op) and 12th week (Post-intervention)
Bone Turnover Marker (Serum Procollagen Type I N-terminal Propeptide (PINP) Level)
Serum PINP levels will be measured using enzyme-linked immunosorbent assay (ELISA) to evaluate bone formation activity. Results will be expressed in nanograms per milliliter (ng/mL). Blood samples will be collected at three time points: pre-surgery, week 4 post-surgery, and week 12 post-surgery
Measured: Pre-surgery, Week 4, Week 12
Bone Turnover Marker (Serum Osteocalcin (OCN) Level)
Serum concentration of Osteocalcin (OCN )will be measured using enzyme-linked immunosorbent assay (ELISA) to evaluate bone turnover. Units will be expressed in nanograms per milliliter (ng/mL). Blood samples will be collected at 3 time points: pre-surgery, week 4, and week 12 post-surgery.
Measured: Pre-surgery, Week 4, Week 12
Bone Turnover Marker (Serum C-terminal Telopeptide of Type I Collagen (CTX) Level)
C-terminal Telopeptide of Type I Collagen (CTX) concentrations will be analyzed using enzyme-linked immunosorbent assay (ELISA) to evaluate bone resorption. Results will be expressed in nanograms per milliliter (ng/mL). Serum will be collected at three time points: before surgery, and at 4 and 12 weeks after surgery.
Measured: Pre-surgery, Week 4, Week 12
Bone Turnover Marker (Serum N-terminal Telopeptide of Type I Collagen (NTX) Level)
N-terminal Telopeptide of Type I Collagen (NTX) will be measured with enzyme-linked immunosorbent assay (ELISA) kits to assess bone resorption activity. Results will be expressed in nanomoles of bone collagen equivalents per liter (nmol BCE/L), according to kit instructions. Samples will be drawn at three time points: pre-surgery, week 4, and week 12 post-surgery.
Measured: Pre-surgery, Week 4, Week 12
30-Second Chair Stand Test
Participants are asked to cross their arms over their chest and stand up from a 44 cm standard chair as many times as possible within 30 seconds. The number of correct repetitions is recorded to assess lower limb functional strength and endurance.
Measured: Week 4 and Week 12
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC index evaluates pain, stiffness, and physical function through 24 items scored from 0 to 4. Higher scores indicate greater impairment.
Measured: Week 4 and Week 12
Muscle Strength (Isometric)
Maximum isometric knee extension (quadriceps) strength will be assessed using a Lafayette digital dynamometer with standardized seated positioning (hip 90°, knee 60° flexion). The average of three trials will be recorded in Newton.
Measured: Week 4 and Week 12
Pain Pressure Threshold (PPT)
Pressure pain threshold will be assessed using a 10-anatomical point digital pressure algometer (J-TECH-USA Commander) that has shown excellent relative and absolute reliability in knee osteoarthritis. Measurements will be recorded in kilogram-force (kg). The average value of the 10 anatomical points will be used for analysis.
Measured: Week 4 and Week 12
Secondary outcomes (9)
Pain Intensity (Visual Analog Scale)
Pain severity during rest, walking, and night will be measured using a 100-mm Visual Analog Scale (VAS). Higher scores represent more severe pain.
Measured: Week 4 and Week 12
Knee Range of Motion (ROM)
Active and passive flexion and extension ROM of the knee will be measured using a Baseline goniometer. Values will be recorded in degrees.
Measured: Week 4 and Week 12
Proprioception (Joint Position Sense)
Active joint position reproduction test at 30° and 60° knee flexion will be performed. The angular error from the target position will be measured using a goniometer. The mean of three trials will be calculated.
Measured: Week 4 and Week 12
Knee Edema Volume
Edema volume will be calculated using circumferential measurements taken every 5 cm between 10 cm proximal and distal to the medial femoral condyle. Volume will be estimated using the Frustum formula.
Measured: Week 4 and Week 12
Biomechanical Muscle Properties (Muscle Tone of Quadriceps)
Muscle tone (resting tension) of the quadriceps (vastus lateralis, vastus medialis, rectus femoris) will be measured using the MyotonPRO device. Measurements will be recorded in Hertz (Hz). Measurements will be made three times for each part of the muscle and the average value will be taken. Separate values will be recorded for vastus lateralis, vastus medialis, rectus femoris.
Measured: Week 4 and Week 12
Biomechanical Muscle Properties (Muscle Stiffness of Quadriceps)
Muscle stiffness of the quadriceps (vastus lateralis, vastus medialis, rectus femoris) will be measured using the MyotonPRO device. Results will be reported in Newtons per meter (N/m). Measurements will be made three times for each part of the muscle and the average value will be taken. Separate values will be recorded for vastus lateralis, vastus medialis, rectus femoris.
Measured: Week 4 and Week 12
Biomechanical Muscle Properties (Muscle Elasticity of Quadriceps)
Muscle elasticity will be characterized by the logarithmic decrement (D) measured using the MyotonPRO device. This is a unitless (relative) value representing the ability of the muscle to restore its shape after deformation. Measurements will be made three times for each part of the muscle and the average value will be taken. Separate values will be recorded for vastus lateralis, vastus medialis, rectus femoris.
Measured: Week 4 and Week 12
Biomechanical Muscle Properties (Muscle Relaxation Time of Quadriceps)
Mechanical stress relaxation time (R) will be measured using the MyotonPRO to assess the time the muscle takes to return to rest following deformation. Results will be reported in milliseconds (ms). Measurements will be made three times for each part of the muscle and the average value will be taken. Separate values will be recorded for vastus lateralis, vastus medialis, rectus femoris.
Measured: Week 4 and Week 12
Biomechanical Muscle Properties (Muscle Creep of Quadriceps)
Muscle creep will be assessed as the ratio of relaxation and deformation time (Creep (C)) using the MyotonPRO device. This parameter is a relative unit and indicates viscoelastic behavior of the muscle. Measurements will be made three times for each part of the muscle and the average value will be taken. Separate values will be recorded for vastus lateralis, vastus medialis, rectus femoris.
Measured: Week 4 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Aug 2025
- Primary completion3 Mar 2026
- Study completion5 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Model description
- Participants will be randomly assigned to one of three parallel arms: Whole Body Vibration (WBV), WBV with exercise, or Control (standard rehabilitation). Each arm will receive a distinct intervention protocol concurrently over the same study period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GÜL DENİZ YILMAZ YELVAR, ASSOCIATE PROFESSOR, Study chair, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988033
- Sponsor's protocol ID
- IstinyeUni-EALOGLUCIFTCI-001
- Status last verified
- Nov 2025
- First submitted
- 16 May 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will share de-identified, summary-level outcome data, including group-level means, standard deviations, effect sizes, and p-values derived from statistical analyses. These data will be provided to support transparency and allow for interpretation of the study findings.
Publications
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.
PubMed 35028919Gazdzik 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.
PubMed 18619880Cardinale 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.
PubMed 12562163Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
PubMed 20699159Klug 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.
PubMed 32671435Sowers M. Epidemiology of risk factors for osteoarthritis: systemic factors. Curr Opin Rheumatol. 2001 Sep;13(5):447-51. doi: 10.1097/00002281-200109000-00018.
PubMed 11604603
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Vibration Applications on Bone Turnover Markers and Functionality After Total Knee Arthroplasty in Women With Osteopenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06988033
- Acronym / sponsor ID
- IstinyeUni-EALOGLUCIFTCI-001
- Conditions
- Osteopenia, Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Osteopenia, Vibration, Women, Bone Turnover Markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 5 Apr 2026 (actual)
- First posted
- 23 May 2025 (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.
Osteoarthritis (OA) is a chronic degenerative disease characterized by the destruction of articular cartilage, leading to functional impairment of surrounding bone and soft tissues. It is a major global public health problem, with the knee joint being the most commonly affected site. Treatment modalities include exercise, diet, oral non-steroidal anti-inflammatory drugs (NSAIDs), intra-articular injections, and total knee arthroplasty (TKA). TKA is indicated in cases of severe pain, functional loss, deformity, and limited range of motion when conservative methods are no longer effective. However, some patients may continue to experience deformity and functional deficits after surgery. Postoperative quadriceps weakness and decreased functional capacity can negatively affect patient prognosis.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel arms: Whole Body Vibration (WBV), WBV with exercise, or Control (standard rehabilitation). Each arm will receive a distinct intervention protocol concurrently over the same study period.
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration | Experimental | Behavioral: Whole Body Vibration TherapyParticipants 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 with Exercise (WBV-E) | Experimental | Behavioral: Whole Body Vibration with ExerciseIn 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. |
| Control | Active comparator | Behavioral: Conventional PhysiotherapyParticipants 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. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to undergo unilateral, primary, cemented total knee arthroplasty (TKA) using a posterior cruciate ligament-sacrificing technique and medial parapatellar approach due to knee osteoarthritis
- 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
Key exclusion criteria (15 listed)
- Scheduled for revision TKA
- 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
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 |
|---|---|---|
| Whole Body Vibration TherapyParticipants 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. | Behavioural | Whole Body Vibration |
| Whole Body Vibration with ExerciseParticipants 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. | Behavioural | Whole Body Vibration with Exercise (WBV-E) |
| Conventional PhysiotherapyParticipants 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. | Behavioural | Control |
Primary outcome
Timed Up and Go (TUG) Test Score
Time frame: Baseline (Week 4 post-op) and 12th week (Post-intervention)
This test evaluates functional mobility and performance-based activity limitation. Participants are instructed to stand up from a standardized chair (height: 44 cm; depth: 26 cm), walk 3 meters at a normal pace, turn around, return, and sit down. The time taken to complete the task is recorded. The TUG test is a valid and reliable indicator of physical function in individuals with knee osteoarthritis.
Bone Turnover Marker (Serum Procollagen Type I N-terminal Propeptide (PINP) Level)
Time frame: Pre-surgery, Week 4, Week 12
Serum PINP levels will be measured using enzyme-linked immunosorbent assay (ELISA) to evaluate bone formation activity. Results will be expressed in nanograms per milliliter (ng/mL). Blood samples will be collected at three time points: pre-surgery, week 4 post-surgery, and week 12 post-surgery
Bone Turnover Marker (Serum Osteocalcin (OCN) Level)
Time frame: Pre-surgery, Week 4, Week 12
Serum concentration of Osteocalcin (OCN )will be measured using enzyme-linked immunosorbent assay (ELISA) to evaluate bone turnover. Units will be expressed in nanograms per milliliter (ng/mL). Blood samples will be collected at 3 time points: pre-surgery, week 4, and week 12 post-surgery.
Bone Turnover Marker (Serum C-terminal Telopeptide of Type I Collagen (CTX) Level)
Time frame: Pre-surgery, Week 4, Week 12
C-terminal Telopeptide of Type I Collagen (CTX) concentrations will be analyzed using enzyme-linked immunosorbent assay (ELISA) to evaluate bone resorption. Results will be expressed in nanograms per milliliter (ng/mL). Serum will be collected at three time points: before surgery, and at 4 and 12 weeks after surgery.
Bone Turnover Marker (Serum N-terminal Telopeptide of Type I Collagen (NTX) Level)
Time frame: Pre-surgery, Week 4, Week 12
N-terminal Telopeptide of Type I Collagen (NTX) will be measured with enzyme-linked immunosorbent assay (ELISA) kits to assess bone resorption activity. Results will be expressed in nanomoles of bone collagen equivalents per liter (nmol BCE/L), according to kit instructions. Samples will be drawn at three time points: pre-surgery, week 4, and week 12 post-surgery.
30-Second Chair Stand Test
Time frame: Week 4 and Week 12
Participants are asked to cross their arms over their chest and stand up from a 44 cm standard chair as many times as possible within 30 seconds. The number of correct repetitions is recorded to assess lower limb functional strength and endurance.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Week 4 and Week 12
The WOMAC index evaluates pain, stiffness, and physical function through 24 items scored from 0 to 4. Higher scores indicate greater impairment.
Muscle Strength (Isometric)
Time frame: Week 4 and Week 12
Maximum isometric knee extension (quadriceps) strength will be assessed using a Lafayette digital dynamometer with standardized seated positioning (hip 90°, knee 60° flexion). The average of three trials will be recorded in Newton.
Pain Pressure Threshold (PPT)
Time frame: Week 4 and Week 12
Pressure pain threshold will be assessed using a 10-anatomical point digital pressure algometer (J-TECH-USA Commander) that has shown excellent relative and absolute reliability in knee osteoarthritis. Measurements will be recorded in kilogram-force (kg). The average value of the 10 anatomical points will be used for analysis.
9 secondary outcomes
Pain Intensity (Visual Analog Scale)
Time frame: Week 4 and Week 12
Knee Range of Motion (ROM)
Time frame: Week 4 and Week 12
Proprioception (Joint Position Sense)
Time frame: Week 4 and Week 12
Knee Edema Volume
Time frame: Week 4 and Week 12
Biomechanical Muscle Properties (Muscle Tone of Quadriceps)
Time frame: Week 4 and Week 12
Biomechanical Muscle Properties (Muscle Stiffness of Quadriceps)
Time frame: Week 4 and Week 12
Biomechanical Muscle Properties (Muscle Elasticity of Quadriceps)
Time frame: Week 4 and Week 12
Biomechanical Muscle Properties (Muscle Relaxation Time of Quadriceps)
Time frame: Week 4 and Week 12
Biomechanical Muscle Properties (Muscle Creep of Quadriceps)
Time frame: Week 4 and Week 12
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 30 Jun 2026.
- Background: PubMed 35028919He 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.
- Background: PubMed 18619880Gazdzik 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.
- Background: PubMed 12562163Cardinale 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.
- Background: PubMed 20699159Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
- Background: PubMed 32671435Klug 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.
- Background: PubMed 11604603Sowers M. Epidemiology of risk factors for osteoarthritis: systemic factors. Curr Opin Rheumatol. 2001 Sep;13(5):447-51. doi: 10.1097/00002281-200109000-00018.
- Individual participant dataSharing planned: Yes. The study will share de-identified, summary-level outcome data, including group-level means, standard deviations, effect sizes, and p-values derived from statistical analyses. These data will be provided to support transparency and allow for interpretation of the study findings.
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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.
GÜL DENİZ YILMAZ YELVAR, ASSOCIATE PROFESSOR study chair
Istinye 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 Whole Body Vibration Therapy, Whole Body Vibration with Exercise and Conventional Physiotherapy in people with Osteopenia and Total Knee Arthroplasty, run by Istinye 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 4 inclusion and 15 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 30 Jun 2026. 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?
Timed Up and Go (TUG) Test Score (time frame: Baseline (Week 4 post-op) and 12th week (Post-intervention)). The study lists 9 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 NCT06988033, which also lists 6 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 30 Jun 2026.