Effects of Whole Body Vibration in Pre-frail Individuals Over 65 Years of Age

NCT06004999 | Completed DMC

• 1 other identifier: TÜTF-GOBEAEK 2022/335
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, individuals aged 65 and over who applied to the physical medicine and rehabilitation outpatient clinic with any complaint will be evaluated in terms of geriatric syndromes. Patients identified as pre-frail will be randomized into the two exercise groups. Exercises of the first group will be performed on the whole body vibration platform and the second will be performed on a flat surface. Before and after the 6-weeks of exercise program; handgrip strength, anterior thigh muscle thickness, body composition, physical performance, mobility, physical activity, balance, kinesiophobia, mood, quality of life, sleep quality, fatigue will be evaluated in both groups. The aim of the study is to show the possible effects of whole body vibration. The results of the study may offer new treatment options that may help prevent the progression of frailty in pre-frail individuals and may guide similar studies.

Conditions

Pre-frail

Keywords

Whole body vibration; Pre-frail; Anterior thigh muscle thickness; Frailty

Outcome Measures

Primary Outcomes (2)

• Anterior thigh muscle thickness

  Anterior thigh muscle thickness will be measured in centimeters by ultrasonography.

  Change from baseline anterior thigh muscle thickness at second, fourth and sixth weeks of intervention.

• Lower Extremity Muscle Strength

  The lower extremities will be evaluated by chair rise test ( also called chair stand test). This test can be used as a proxy for strength of leg muscles (quadriceps muscle group). The chair stand test measures the amount of time needed for a patient to rise five times from a seated position without using his or her arms; the timed chair stand test is a variation that counts how many times a patient can rise and sit in the chair over a 30-second interval.

  Change from baseline lower extremity muscle strength at sixth weeks of intervention

Secondary Outcomes (11)

• Hand grip strength

  Change from baseline hand grip strength at sixth weeks of intervention

• Skeletal muscle mass index (SMI)

  Change from baseline skeletal muscle mass index at sixth weeks of intervention

• Physical performance

  Change from baseline physical performance at sixth weeks of intervention

• Mobility

  Change from baseline mobility at sixth weeks of intervention

• Physical activity

  Change from baseline physical activity at sixth weeks of intervention

Study Arms (2)

Vibration group

EXPERIMENTAL

An exercise program organized by the researchers on the vibration platform will be applied to the pre-frail participants in the vibration group. The exercises will be applied 5 days a week for 6 weeks.

Other: Whole body vibration

Control group

ACTIVE COMPARATOR

An exercise program organized by the researchers (same exercise program as the vibration group) will be applied to the pre-frail participants in the control group on a flat surface. The exercises will be applied 5 days a week for 6 weeks.

Other: The exercise program on flat ground without a vibration platform

Interventions

Whole body vibration OTHER

All patients will be pedaling for 5 minutes, followed by a warm-up phase with 5 minutes of stretching for the hamstring, gastrocnemius, soleus, and quadriceps muscles. Afterward, the following exercise program on the vibration platform will be applied to the 1st group. * Lunge, * Squat, * Deep squat, * Wide stance squat, * Calves, * Deep calves. The exercise time will be 6 minutes in the first week, and the exercise time will be increased in the following weeks, and the total exercise time will continue at 18 minutes in the last week.

Vibration group

The exercise program on flat ground without a vibration platform OTHER

All patients will be pedaling for 5 minutes, followed by a warm-up phase with 5 minutes of stretching for the hamstring, gastrocnemius, soleus, and quadriceps muscles. Afterward, the following exercise program will be applied to the group. The exercise program will be applied to the 2nd group (controls) on flat ground without a vibration platform. * Lunge, * Squat, * Deep squat, * Wide stance squat, * Calves, * Deep calves. The exercise time will be 6 minutes in the first week, and the exercise time will be increased in the following weeks, and the total exercise time will continue at 18 minutes in the last week.

Control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years and older
• Those who agreed to participate in the study
• Groups that have the authority to understand and listen to the questions posed
• Having no regular exercise habits

You may not qualify if:

• Communication disorder that prevents storytelling and cooperation
• Serious neurological disease (central nervous system disorders such as paralysis, spinal cord injury, parkinsonism)
• Advanced cardiovascular disease (decongestive heart failure, recent myocardial infarction)
• Serious pulmonary disease (COPD exacerbation, acute pulmonary embolism)
• Physical disability such as lower extremity amputation, surgery
• Implant (pacemaker, artificial heart valve, stent, hip replacement, knee replacement)
• Pregnancy
• Epilepsy
• Having gallstones, kidney stones, bladder stones
• Acute inflammation, infection
• Acute or previous deep vein thrombosis
• Presence of a history of malignant disease
• History of fracture in the last 6 months
• History of lower extremity surgery in the last 12 months
• Having a regular exercise habit

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University Medical Faculty

Edirne, 22030, Turkey (Türkiye)

Location

Related Publications (6)

• Morley JE, Haren MT, Rolland Y, Kim MJ. Frailty. Med Clin North Am. 2006 Sep;90(5):837-47. doi: 10.1016/j.mcna.2006.05.019.

  PMID: 16962845 BACKGROUND

• Dent E, Martin FC, Bergman H, Woo J, Romero-Ortuno R, Walston JD. Management of frailty: opportunities, challenges, and future directions. Lancet. 2019 Oct 12;394(10206):1376-1386. doi: 10.1016/S0140-6736(19)31785-4.

  PMID: 31609229 BACKGROUND

• Stania M, Juras G, Slomka K, Chmielewska D, Krol P. The application of whole-body vibration in physiotherapy - A narrative review. Physiol Int. 2016 Jun 1;103(2):133-145. doi: 10.1556/036.103.2016.2.1.

  PMID: 28639859 BACKGROUND

• Lam FM, Lau RW, Chung RC, Pang MY. The effect of whole body vibration on balance, mobility and falls in older adults: a systematic review and meta-analysis. Maturitas. 2012 Jul;72(3):206-13. doi: 10.1016/j.maturitas.2012.04.009. Epub 2012 May 18.

  PMID: 22609157 BACKGROUND

• Zhang L, Weng C, Liu M, Wang Q, Liu L, He Y. Effect of whole-body vibration exercise on mobility, balance ability and general health status in frail elderly patients: a pilot randomized controlled trial. Clin Rehabil. 2014 Jan;28(1):59-68. doi: 10.1177/0269215513492162. Epub 2013 Jul 17.

  PMID: 23864514 BACKGROUND

• Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.

  PMID: 32941253 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Filiz Tuna

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: August 22, 2023
• Study Start: September 15, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

TU (1)