Effects of Whole Body Vibration in Pre-frail Individuals Over 65 Years of Age: Randomized Clinical Trial

Pre-frail Clinical Trial

Official title:

The Relationship Between Whole Body Vibration and Muscle Strength and Thickness, Body Composition, Physical Performance, Balance, Kinesiophobia, Mood, Fatigue, Quality of Life, and Sleep in "Pre-frail" Individuals Over 65 Years of Age: Randomized Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06004999
• Other study ID #: TÜTF-GOBEAEK 2022/335
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: August 2023
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 progresion 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 58
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pre-frail

Intervention

Other:
• Whole body vibration
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 platform
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.

Locations

Country	Name	City	State
Turkey	Trakya University Medical Faculty	Edirne

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	Change from baseline hand grip strength at sixth weeks of intervention
Secondary	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).	Change from baseline skeletal muscle mass index at sixth weeks of intervention
Secondary	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.	Change from baseline physical performance at sixth weeks of intervention
Secondary	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.	Change from baseline mobility at sixth weeks of intervention
Secondary	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.	Change from baseline physical activity at sixth weeks of intervention
Secondary	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.	Change from baseline balance at sixth weeks of intervention
Secondary	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.	Change from baseline kinesiophobia at sixth weeks of intervention
Secondary	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.	Change from baseline mood at sixth weeks of intervention
Secondary	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 mesaured by SF-36. In this test every subgroup is scored between 0 to 100 and higher score means better outcome.	Change from baseline life quality at sixth weeks of intervention
Secondary	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.	Change from baseline sleep quality at sixth weeks of intervention
Secondary	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.	Change from baseline fatigue at sixth weeks of intervention