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Pre-frailNCT06004999

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

A study testing Whole body vibration and The exercise program on flat ground without a vibration platform in people with Pre-frail, run by Trakya University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Pre-frail
What is being tested?
Whole body vibration and The exercise program on flat ground without a vibration platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2023to 1 Mar 2024
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 65 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

Who cannot join

  • 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)
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Trakya University Medical Faculty

    Edirne, 22030

Other trials in Turkey (Türkiye)

About this study

Official title: Differential Effects of Whole-Body Vibration and Floor Exercises on Muscle Architecture, Functional Performance, and Well-Being in Pre-Frail Seniors: A Randomized Controlled Trial

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.

Read the detailed description

Frailty is included in geriatric syndromes and is accepted as a precursor of other geriatric syndromes. The elderly who do not meet all the frailty criteria but are at risk are defined as "pre-frail". In many studies %50 of individuals aged 65 and over who appear healthy have been identified at an early stage and their progression to frailty can be reduced or prevented.

Proven treatment approaches for physical frailty include aerobic and resistive exercise. As a result of this study, it is predicted that whole body vibration may be an alternative treatment modality for "pre-frail " individuals who cannot do aerobic and resistive exercises or who are inconvenient to do these exercises.

In the literature, the effect of whole body vibration on muscle strength, balance, physical performance and spasticity in various age groups have been shown. There are no studies showing the effect of whole body vibration in pre-frail individuals and investigating the effect of whole body vibration on anterior thigh muscle thickness. In this study, pre-frail patients will be randomized into exercise groups. 6-week exercise programme is planned to be performed on whole body vibration platform for one group and on flat ground for the other group. The relationship between whole body vibration application and anterior thigh muscle thickness will be examined by measuring the anterior thigh muscle thickness of all participants via ultrasonography (USG). In addition, the relationship between whole body vibration application and body composition, physical performance, balance, kinesiophobia, mood, fatigue, quality of life and sleep will be examined.

Conditions
Pre-frail
Being tested
Whole body vibration, The exercise program on flat ground without a vibration platform
Keywords
Whole body vibration, Pre-frail, Anterior thigh muscle thickness, Frailty
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole body vibrationOther

    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.
  • The exercise program on flat ground without a vibration platformOther

    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.
Study groups in NCT06004999
Study groupRoleWhat they receive
Vibration groupExperimentalAn 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.
Receives: Other: Whole body vibration
Control groupActive comparatorAn 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.
Receives: Other: The exercise program on flat ground without a vibration platform

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anterior thigh muscle thickness

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

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

  2. 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.

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

Secondary outcomes (11)
  1. Hand grip strength

    Hand grip strength is a reliable measurement when standardised methods and calibrated equipment are used, even when there are different assessors or different brands of dynamometers. Hand grip strength will be measured by Jamar Analogue Hand Dynamometer in kilograms.

    Measured: Change from baseline hand grip strength at sixth weeks of intervention

  2. Skeletal muscle mass index (SMI)

    Skeletal muscle mass index (SMI) will be measured in kg/m² by dividing the appendicular skeletal muscle mass (kg) by the square of the height (m) using bioelectrical impedance analysis (BIA).

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

  3. Physical performance

    The Short Physical Performance Battery (SPPB) is used to determine physical performance. The SPPB is a composite test that includes assessment of walking speed, balance test, and chair rise test.

    Measured: Change from baseline physical performance at sixth weeks of intervention

  4. Mobility

    Mobility will be determined by the timed get-and-go test. The test measures speed during many functional maneuvers such as standing up, walking, turning, and sitting.

    Measured: Change from baseline mobility at sixth weeks of intervention

  5. Physical activity

    Physical activity will be assessed using the International Physical Activity Questionnaire - short form (IPAQ). It provides information about time spent walking, moderate- intensity activity, vigorous-intensity activity and sedentary activity.

    Measured: Change from baseline physical activity at sixth weeks of intervention

  6. Balance

    Balance will be scored by Berg balance test and Tinetti balance-gait tests. Berg balance test scores balance between 0 to 56 in which higher score means better outcome. Tinetti balance-gait test scores balance between 0 to 9 in which higher score means better outcome.

    Measured: Change from baseline balance at sixth weeks of intervention

  7. Kinesiophobia

    Kinesiophobia will be determined by the Tampa Kinesiophobia Scale. It consists of 17 questions including pain, injury, fear and avoidance parameters related to physical activities.

    Measured: Change from baseline kinesiophobia at sixth weeks of intervention

  8. Mood

    Depression will be assessed using Geriatric Depression Scale. This scale consists of 30 questions. A total score of 0-10 means no depression, 11-13 means likely depression, above 14 means definite depression.

    Measured: Change from baseline mood at sixth weeks of intervention

  9. Life quality

    The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, self-reported measure of health. Life quality will be measured by SF-36. In this test every subgroup is scored between 0 to 100 and higher score means better outcome.

    Measured: Change from baseline life quality at sixth weeks of intervention

  10. Sleep quality

    Sleep quality will be determined by The Pittsburgh Sleep Quality Index (PSQI). The scale includes 7 components. Every component is scored between 0 to 3. A total score above 5 is considered poor sleep quality.

    Measured: Change from baseline sleep quality at sixth weeks of intervention

  11. Fatigue

    Fatigue will be evaluated with the fatigue severity scale. The scale includes 9 questions, each of which consists of a score scale of 1-7. The scale determines the fatigue levels of the participants in the last 1 month.

    Measured: Change from baseline fatigue at sixth weeks of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2023
  2. Study start15 Sep 2023
  3. Primary completion1 Mar 2024
  4. Study completion1 Mar 2024

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06004999
Sponsor's protocol ID
TÜTF-GOBEAEK 2022/335
Status last verified
May 2025
First submitted
14 Jun 2023
Last updated
28 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 16962845
  • 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.

    PubMed 31609229
  • 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.

    PubMed 28639859
  • 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.

    PubMed 22609157
  • 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.

    PubMed 23864514
  • 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.

    PubMed 32941253

Questions about this trial

What is this clinical trial studying?

A study testing Whole body vibration and The exercise program on flat ground without a vibration platform in people with Pre-frail, run by Trakya 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 28 May 2025. 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?

Anterior thigh muscle thickness (time frame: Change from baseline anterior thigh muscle thickness at second, fourth and sixth weeks of intervention.). 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 NCT06004999, 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 28 May 2025.

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