xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06004999</url>
    </required_header>
    <id_info>
      <org_study_id>TÜTF-GOBEAEK 2022/335</org_study_id>
      <nct_id>NCT06004999</nct_id>
    </id_info>
    <brief_title>Effects of Whole Body Vibration in Pre-frail Individuals Over 65 Years of Age: Randomized Clinical Trial</brief_title>
    <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 &quot;Pre-frail&quot; Individuals Over 65 Years of Age: Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Trakya University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Trakya University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this study, individuals aged 65 and over who applied to the physical medicine and&#xD;
        rehabilitation outpatient clinic with any complaint will be evaluated in terms of geriatric&#xD;
        syndromes. Patients identified as pre-frail will be randomized into the two exercise groups.&#xD;
        Exercises of the first group will be performed on the whole body vibration platform and the&#xD;
        second will be performed on a flat surface. Before and after the 6-weeks of exercise program;&#xD;
        handgrip strength, anterior thigh muscle thickness, body composition, physical performance,&#xD;
        mobility, physical activity, balance, kinesiophobia, mood, quality of life, sleep quality,&#xD;
        fatigue will be evaluated in both groups. The aim of the study is to show the possible&#xD;
        effects of whole body vibration. The results of the study may offer new treatment options&#xD;
        that may help prevent the progression of frailty in pre-frail individuals and may guide&#xD;
        similar studies.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Frailty is included in geriatric syndromes and is accepted as a precursor of other geriatric&#xD;
        syndromes. The elderly who do not meet all the frailty criteria but are at risk are defined&#xD;
        as &quot;pre-frail&quot;. In many studies %50 of individuals aged 65 and over who appear healthy have&#xD;
        been identified at an early stage and their progresion to frailty can be reduced or&#xD;
        prevented.&#xD;
  &#xD;
        Proven treatment approaches for physical frailty include aerobic and resistive exercise. As a&#xD;
        result of this study, it is predicted that whole body vibration may be an alternative&#xD;
        treatment modality for &quot;pre-frail &quot; individuals who cannot do aerobic and resistive exercises&#xD;
        or who are inconvenient to do these exercises.&#xD;
  &#xD;
        In the literature, the effect of whole body vibration on muscle strength, balance, physical&#xD;
        performance and spasticity in various age groups have been shown. There are no studies&#xD;
        showing the effect of whole body vibration in pre-frail individuals and investigating the&#xD;
        effect of whole body vibration on anterior thigh muscle thickness. In this study, pre-frail&#xD;
        patients will be randomized into exercise groups. 6-week exercise programme is planned to be&#xD;
        performed on whole body vibration platform for one group and on flat ground for the other&#xD;
        group. The relationship between whole body vibration application and anterior thigh muscle&#xD;
        thickness will be examined by measuring the anterior thigh muscle thickness of all&#xD;
        participants via ultrasonography (USG). In addition, the relationship between whole body&#xD;
        vibration application and body composition, physical performance, balance, kinesiophobia,&#xD;
        mood, fatigue, quality of life and sleep will be examined.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Anterior thigh muscle thickness</measure>
      <time_frame>Change from baseline anterior thigh muscle thickness at second, fourth and sixth weeks of intervention.</time_frame>
      <description>Anterior thigh muscle thickness will be measured in centimeters by ultrasonography.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lower Extremity Muscle Strength</measure>
      <time_frame>Change from baseline lower extremity muscle strength at sixth weeks of intervention</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hand grip strength</measure>
      <time_frame>Change from baseline hand grip strength at sixth weeks of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skeletal muscle mass index (SMI)</measure>
      <time_frame>Change from baseline skeletal muscle mass index at sixth weeks of intervention</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical performance</measure>
      <time_frame>Change from baseline physical performance at sixth weeks of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mobility</measure>
      <time_frame>Change from baseline mobility at sixth weeks of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity</measure>
      <time_frame>Change from baseline physical activity at sixth weeks of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Balance</measure>
      <time_frame>Change from baseline balance at sixth weeks of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Kinesiophobia</measure>
      <time_frame>Change from baseline kinesiophobia at sixth weeks of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mood</measure>
      <time_frame>Change from baseline mood at sixth weeks of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Life quality</measure>
      <time_frame>Change from baseline life quality at sixth weeks of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep quality</measure>
      <time_frame>Change from baseline sleep quality at sixth weeks of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue</measure>
      <time_frame>Change from baseline fatigue at sixth weeks of intervention</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">58</enrollment>
    <condition>Pre-frail</condition>
    <arm_group>
      <arm_group_label>Vibration group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Whole body vibration</intervention_name>
      <description>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.&#xD;
  Afterward, the following exercise program on the vibration platform will be applied to the 1st group.&#xD;
  Lunge,&#xD;
  Squat,&#xD;
  Deep squat,&#xD;
  Wide stance squat,&#xD;
  Calves,&#xD;
  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.</description>
      <arm_group_label>Vibration group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>The exercise program on flat ground without a vibration platform</intervention_name>
      <description>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.&#xD;
  Afterward, the following exercise program will be applied to the group.&#xD;
  The exercise program will be applied to the 2nd group (controls) on flat ground without a vibration platform.&#xD;
  Lunge,&#xD;
  Squat,&#xD;
  Deep squat,&#xD;
  Wide stance squat,&#xD;
  Calves,&#xD;
  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.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 65 years and older&#xD;
  &#xD;
            2. Those who agreed to participate in the study&#xD;
  &#xD;
            3. Groups that have the authority to understand and listen to the questions posed&#xD;
  &#xD;
            4. Having no regular exercise habits&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Communication disorder that prevents storytelling and cooperation&#xD;
  &#xD;
            2. Serious neurological disease (central nervous system disorders such as paralysis,&#xD;
               spinal cord injury, parkinsonism)&#xD;
  &#xD;
            3. Advanced cardiovascular disease (decongestive heart failure, recent myocardial&#xD;
               infarction)&#xD;
  &#xD;
            4. Serious pulmonary disease (COPD exacerbation, acute pulmonary embolism)&#xD;
  &#xD;
            5. Physical disability such as lower extremity amputation, surgery&#xD;
  &#xD;
            6. Implant (pacemaker, artificial heart valve, stent, hip replacement, knee replacement)&#xD;
  &#xD;
            7. Pregnancy&#xD;
  &#xD;
            8. Epilepsy&#xD;
  &#xD;
            9. Having gallstones, kidney stones, bladder stones&#xD;
  &#xD;
           10. Acute inflammation, infection&#xD;
  &#xD;
           11. Acute or previous deep vein thrombosis&#xD;
  &#xD;
           12. Presence of a history of malignant disease&#xD;
  &#xD;
           13. History of fracture in the last 6 months&#xD;
  &#xD;
           14. History of lower extremity surgery in the last 12 months&#xD;
  &#xD;
           15. Having a regular exercise habit&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Filiz Tuna</last_name>
      <role>Principal Investigator</role>
      <affiliation>Trakya University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Trakya University Medical Faculty</name>
        <address>
          <city>Edirne</city>
          <zip>22030</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <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>
      <PMID>16962845</PMID>
    </reference>
    <reference>
      <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>
      <PMID>31609229</PMID>
    </reference>
    <reference>
      <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>
      <PMID>28639859</PMID>
    </reference>
    <reference>
      <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>
      <PMID>22609157</PMID>
    </reference>
    <reference>
      <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>
      <PMID>23864514</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>32941253</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Trakya University</investigator_affiliation>
      <investigator_full_name>FİLİZ TUNA</investigator_full_name>
      <investigator_title>Assoc. Prof.</investigator_title>
    </responsible_party>
    <keyword>Whole body vibration</keyword>
    <keyword>Pre-frail</keyword>
    <keyword>Anterior thigh muscle thickness</keyword>
    <keyword>Fraility</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06004999
  org study id: TÜTF-GOBEAEK 2022/335
  nct id: NCT06004999
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Anterior thigh muscle thickness
  time frame: Change from baseline anterior thigh muscle thickness at second, fourth and sixth weeks of intervention.
  description: Anterior thigh muscle thickness will be measured in centimeters by ultrasonography.
  measure: Lower Extremity Muscle Strength
  time frame: Change from baseline lower extremity muscle strength at sixth weeks of intervention
  description: 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.
  measure: Hand grip strength
  time frame: Change from baseline hand grip strength at sixth weeks of intervention
  description: 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.
  measure: Skeletal muscle mass index (SMI)
  time frame: Change from baseline skeletal muscle mass index at sixth weeks of intervention
  description: 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).
  measure: Physical performance
  time frame: Change from baseline physical performance at sixth weeks of intervention
  description: 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.
  measure: Mobility
  time frame: Change from baseline mobility at sixth weeks of intervention
  description: 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.
  measure: Physical activity
  time frame: Change from baseline physical activity at sixth weeks of intervention
  description: 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.
  measure: Balance
  time frame: Change from baseline balance at sixth weeks of intervention
  description: 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.
  measure: Kinesiophobia
  time frame: Change from baseline kinesiophobia at sixth weeks of intervention
  description: 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.
  measure: Mood
  time frame: Change from baseline mood at sixth weeks of intervention
  description: 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.
  measure: Life quality
  time frame: Change from baseline life quality at sixth weeks of intervention
  description: 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.
  measure: Sleep quality
  time frame: Change from baseline sleep quality at sixth weeks of intervention
  description: 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.
  measure: Fatigue
  time frame: Change from baseline fatigue at sixth weeks of intervention
  description: 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.
  arm group label: Vibration group
  arm group type: Experimental
  description: 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.
  arm group label: Control group
  arm group type: Active Comparator
  description: 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.
  intervention type: Other
  intervention name: Whole body vibration
  description: 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.
  arm group label: Vibration group
  intervention type: Other
  intervention name: The exercise program on flat ground without a vibration platform
  description: 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.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Filiz Tuna
  role: Principal Investigator
  affiliation: Trakya University
  facility: 
  country: Turkey
  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.
  PMID: 16962845
  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.
  PMID: 31609229
  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.
  PMID: 28639859
  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.
  PMID: 22609157
  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.
  PMID: 23864514
  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.
  PMID: 32941253
  responsible party type: Principal Investigator
  investigator affiliation: Trakya University
  investigator full name: FİLİZ TUNA
  investigator title: Assoc. Prof.