Clinical trial NCT06004999: Effects of Whole Body Vibration in Pre-frail Individuals Over 65 Years of Age
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-frail
Keywords: Whole body vibration
Pre-frail
Anterior thigh muscle thickness
Frailty
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 58
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 65 years and older
2. Those who agreed to participate in the study
3. Groups that have the authority to understand and listen to the questions posed
4. Having no regular exercise habits

Exclusion Criteria:

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

Primary outcomes:
measure: Anterior thigh muscle thickness
timeFrame: Change from baseline anterior thigh muscle thickness at second, fourth and sixth weeks of intervention.
measure: Lower Extremity Muscle Strength
timeFrame: Change from baseline lower extremity muscle strength at sixth weeks of intervention
Secondary outcomes:
measure: Hand grip strength
timeFrame: Change from baseline hand grip strength at sixth weeks of intervention
measure: Skeletal muscle mass index (SMI)
timeFrame: Change from baseline skeletal muscle mass index at sixth weeks of intervention
measure: Physical performance
timeFrame: Change from baseline physical performance at sixth weeks of intervention
measure: Mobility
timeFrame: Change from baseline mobility at sixth weeks of intervention
measure: Physical activity
timeFrame: Change from baseline physical activity at sixth weeks of intervention
measure: Balance
timeFrame: Change from baseline balance at sixth weeks of intervention
measure: Kinesiophobia
timeFrame: Change from baseline kinesiophobia at sixth weeks of intervention
measure: Mood
timeFrame: Change from baseline mood at sixth weeks of intervention
measure: Life quality
timeFrame: Change from baseline life quality at sixth weeks of intervention
measure: Sleep quality
timeFrame: Change from baseline sleep quality at sixth weeks of intervention
measure: Fatigue
timeFrame: Change from baseline fatigue at sixth weeks of intervention
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
Study officials:
affiliation: Trakya University
name: Filiz Tuna
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.