Protocol summary
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Study aim
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Investigating the effect of whole body vibration on muscle mass, muscle strength, biomechanical parameters of gait and balance, glucose metabolism factors and inflammatory factors in people with diabetic sarcopenia
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Design
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People with diabetic sarcopenia are randomly (with block randomization method) divided into intervention group (with whole body vibration) and control group (without vibration). The clinical trial has a randomized control group with a sample size of 60. There is no trial phase.
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Settings and conduct
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This study would be conducted at the Movement Disorders Research Center of Tarbiat Modares University and the Endocrine Center of Tehran University of Medical Sciences. The subjects under study are patients with diabetic sarcopenia.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Diabetic patients who have been diagnosed for at least 6 months and are diagnosed with sarcopenia according to the diagnostic parameters; age between 60 to 80 years old;
Exclusion criteria: History of acute ischemia in the past 6 months; GFR score above 30; neuropathy score above 13; suffering from thyroid problems.
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Intervention groups
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The intervention group will receive 12 weeks of whole body vibration. The control group will receive any intervention during 12 weeks.
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Main outcome variables
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Ground Reaction Force parameters, body sway parameters, quality of life questioner , body mass parameters
General information
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Reason for update
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Update study information
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201128049511N6
Registration date:
2024-01-16, 1402/10/26
Registration timing:
prospective
Last update:
2025-05-02, 1404/02/12
Update count:
1
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Registration date
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2024-01-16, 1402/10/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-01-20, 1402/10/30
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Expected recruitment end date
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2025-07-21, 1404/04/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of whole body vibration on muscle mass, biomechanical parameters and metabolic factors in diabetic patients with sarcopenia
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Public title
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The effect of whole body vibration on patients with diabetic sarcopenia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
At least 6 months history of diabetes
Diagnosis of sarcopenia in people with diabetes
Score less than 13 on Michigan Neuropathy Screening Instrument
Exclusion criteria:
Having thyroid disorders
GFR score above 30
History of acute ischemia such as infarction in less than 3 months
History of falling in the past year
Taking drugs and supplements that have known effects on the neuromuscular system (such as corticosteroids)
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Age
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From 60 years old to 80 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization in this study will be done by block randomization method. Participants will be randomly assigned into intervention or control groups. The size of blocks will be 4. Also, the blocks will be randomly placed in the envelopes. For random assignment, code 1 denotes the intervention group and code 0 denotes the control group in the envelopes. Subjects will choose an envelope and then, based on the chosen code, they are assigned to one of the groups.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-11-26, 1402/09/05
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Ethics committee reference number
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IR.MODARES.REC.1402.123
Health conditions studied
1
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Description of health condition studied
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Sarcopenia
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ICD-10 code
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M62.84
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ICD-10 code description
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Sarcopenia
2
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Description of health condition studied
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Type 2 diabetes
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ICD-10 code
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E11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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Ground Reaction Force Parameters
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Timepoint
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Before and after 12 weeks of intervention
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Method of measurement
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Force plate device
2
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Description
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Quality of Life Index
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Timepoint
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Before and after 12 weeks of interventions
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Method of measurement
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SarQoL questionnaire
3
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Description
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Parameters of the body sway
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Timepoint
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قبل و بعد از 12 هفته مداخله
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Method of measurement
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Force plate
4
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Description
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body mass parameters
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Timepoint
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قبل و بعد از 12 هفته مداخله
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Method of measurement
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DXA
Secondary outcomes
1
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Description
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Muscle strength
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Timepoint
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Before and after 12 weeks of intervention
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Method of measurement
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Dynamometer
2
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Description
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lipid profile
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Timepoint
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Before and after 12 weeks of intervention
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Method of measurement
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Blood test
3
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Description
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fasting blood sugar(FBS)
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Timepoint
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Before and after 12 weeks of intervention
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Method of measurement
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Blood test
4
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Description
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glycated hemoglobin (A1C)
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Timepoint
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Before and after 12 weeks of intervention
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Method of measurement
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Blood test
5
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Description
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inflammation factors
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Timepoint
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Before and after 12 weeks of intervention
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Method of measurement
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Blood test
Intervention groups
1
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Description
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Intervention group: The intervention consists of 12 weeks of whole body vibration for individuals with diabetic sarcopenia. In the first session, after registering the basic information and getting familiar with how to perform the tests, the subjects will perform biomechanical and blood tests and then the variables will be recorded. In the next sessions, people should perform 3 times a week for 12 weeks, 5 to 12 vibration sets each with 60 seconds of vibration and 30 seconds of rest. After the end of 12 weeks, the final assessment session will be done in the laboratory like the first session. If subjects complete 80% of the sessions, which includes at least 30 treatment sessions, they will be included in the statistical analysis.
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Category
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Treatment - Other
2
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Description
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Control group: This group will not receive any vibration and the subjects will be evaluated before and after 12 weeks. In the first session, after registering the basic information and getting familiar with how to perform the tests, the subject will perform biomechanical and blood tests and then the variables will be recorded. After the end of 12 weeks, the final assessment session will be done in the laboratory like the first session.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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University of Tarbiat Modares
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Proportion provided by this source
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50
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Research Institute of Endocrinology and Metabolism, Tehran Faculty of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information about the main outcome can be shared when the subjects be made unidentifiable.
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When the data will become available and for how long
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The access phase starts six months after the results publication
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To whom data/document is available
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Researchers in academic and research organizations will have access to the data.
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Under which criteria data/document could be used
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To do scientific research
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From where data/document is obtainable
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Sahar Boozari, Adress: Tarbiat Modares University; Jalal Al Ahmad Highway; Email: s.boozari@modares.ac.ir; Phone number: 00982182885053
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What processes are involved for a request to access data/document
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After sending the project plan and a complete evaluation of the persons and organizations involved in the project, the data will be sent following the approval.
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Comments
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