The Effect of Whole-Body Vibration Treatment Before Total Knee Arthroplasty

NCT ID: NCT05967637

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-10-01

Brief Summary

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The study's objective is to investigate the effects of whole-body vibration therapy administered before surgery on various factors related to patients who undergo total knee arthroplasty. These factors include pain, swelling, skin temperature, normal joint movement, knee joint position sense, knee extensor muscle strength, functional status, and patient satisfaction.

Detailed Description

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The study will include participants aged 50-80 who are planning to undergo total knee arthroplasty. According to the sample size analysis, a total of 40 people will be included in this study. The enrolled participants will be randomly assigned to one of two parallel groups: the whole-body vibration group or the sham whole-body vibration group. Both groups will receive standard patient education and exercise training.The experimental group will receive whole-body vibration along with exercise on the whole-body vibration device, while the control group (sham group) will receive sham vibration on the same device. All participants will receive treatment for a total of 5 days, one session per day.

Conditions

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Whole-body Vibration Arthropathy of Knee Swelling/ Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Whole-body vibration

Standard patient education and exercise training + whole body vibration

Group Type EXPERIMENTAL

Whole body vibration

Intervention Type OTHER

The vibration will be applied for 10 minutes (30 seconds rest, 30 seconds training, 10 reps) in total with a low frequency (20 HZ) and low amplitude (2mm). Participants will be asked to stand in a squatting position by semi-flexing (30°) their knees during the 30-second vibration period.

Sham-whole-body vibration

Standard patient education and exercise training + sham whole body vibration

Group Type SHAM_COMPARATOR

Sham-Whole body vibration

Intervention Type OTHER

The sham-whole body vibration treatment will follow the same procedures with the vibration machine off.

Interventions

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Whole body vibration

The vibration will be applied for 10 minutes (30 seconds rest, 30 seconds training, 10 reps) in total with a low frequency (20 HZ) and low amplitude (2mm). Participants will be asked to stand in a squatting position by semi-flexing (30°) their knees during the 30-second vibration period.

Intervention Type OTHER

Sham-Whole body vibration

The sham-whole body vibration treatment will follow the same procedures with the vibration machine off.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with advanced idiopathic knee OA and scheduled for unilateral total knee arthroplasty will be considered candidates for the present study and will be asked to participate

Exclusion Criteria

* if they had undergone another hip or knee joint replacement in the previous year
* if they had any medical condition in which exercise was contraindicated
* if they had any disease that affected functional performance
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gulhane Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Sevim Beyza Ölmez

Principal Investigator, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeynep Hazar

Role: STUDY_DIRECTOR

Gazi University

Cemil Yıldız

Role: STUDY_CHAIR

Gulhane Training and Research Hospital

Sevim Beyza Ölmez

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Beyza Yazgan

Role: PRINCIPAL_INVESTIGATOR

Gazi University

İnci Ayaş

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

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Gazi University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023-874

Identifier Type: -

Identifier Source: org_study_id

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