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
Design
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 40. There is no trial phase.
Settings and conduct
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. The study is single blind in which the assessor is not aware of the grouping.
Participants/Inclusion and exclusion criteria
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 45 to 78 years old; without osteoporosis and vitamin D deficiency.
Exclusion criteria: History of acute ischemia in the past 6 months; GFR score above 30; neuropathy score above 13; suffering from thyroid problems.
Intervention groups
The intervention group will receive 8 weeks of whole body vibration. The control group will receive any intervention during 8 weeks.
Main outcome variables
Ground Reaction Force parameters, body sway parameters, TNF-a, IL-6, FBS, A1c and HSCRP factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201128049511N6
Registration date:2024-01-16, 1402/10/26
Registration timing:registered_while_recruiting
Last update:2024-01-16, 1402/10/26
Update count:1
Registration date
2024-01-16, 1402/10/26
Registrant information
Name
Sahar Boozari
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 5053
Email address
s.boozari@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of whole body vibration on muscle mass, biomechanical parameters and metabolic factors in diabetic patients with sarcopenia
Public title
The effect of whole body vibration on patients with diabetic sarcopenia
Purpose
Treatment
Inclusion/Exclusion criteria
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
Normal Vitamin D level
t-score above -2.5
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)
Age
From 45 years old to 78 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person registering the laboratory data and the participants in the project are not aware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2023-11-26, 1402/09/05
Ethics committee reference number
IR.MODARES.REC.1402.123
Health conditions studied
1
Description of health condition studied
Sarcopenia
ICD-10 code
M62.84
ICD-10 code description
Sarcopenia
2
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Ground Reaction Force Parameters
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Force plate device
2
Description
fasting blood sugar (FBS)
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Blood test
3
Description
Quality of Life Index
Timepoint
Before and after 8 weeks of interventions
Method of measurement
SarQoL questionnaire
4
Description
Parameters of the body sway
Timepoint
before and after 8 weeks of intervention
Method of measurement
Force plate
5
Description
Three month blood sugar(hbA1C)
Timepoint
before and after 8 weeks of intervention
Method of measurement
Blood test
6
Description
inter Lucien 6 (IL-6)
Timepoint
before and after 8 weeks of intervention
Method of measurement
Blood test
7
Description
Tumor necrosis factor alpha(TNF-a)
Timepoint
before and after 8 weeks of intervention
Method of measurement
Blood test
8
Description
High-sensitivity C-reactive protein (hsCRP)
Timepoint
before and after 8 weeks of intervention
Method of measurement
Blood test
Secondary outcomes
1
Description
Muscle strength
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Dynamometer
2
Description
Triglyceride
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Blood test
3
Description
Cholesterol
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Blood test
4
Description
Low-density lipoprotein(LDL)
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Blood test
5
Description
High-density lipoprotein(HDL)
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: The intervention consists of 8 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 8 weeks, 5 to 10 vibration sets each with 60 seconds of vibration and 30 seconds of rest. After the end of 8 weeks, the final assessment session will be done in the laboratory like the first session.
Category
Treatment - Other
2
Description
Control group: This group will not receive any vibration and the subjects will be evaluated before and after 8 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 8 weeks, the final assessment session will be done in the laboratory like the first session.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Treatment Center for Movement Disorders of Tarbiat Modares University
Full name of responsible person
Sahar Boozari
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Fax
+98 21 8800 6544
Email
s.boozari@modares.ac.ir
Web page address
http://ptmodares.ir
2
Recruitment center
Name of recruitment center
Research Institute of Endocrinology and Metabolism, Tehran University of Medical Sciences
Full name of responsible person
Gita Shafiee
Street address
Research Institute of Endocrinology and Metabolism, Tehran University of Medical Sciences ,Next to Dr. Shariati Hospital, Jalal Al ahmad Highw
City
Tehran
Province
Tehran
Postal code
1411713119
Phone
+98 21 8863 1298
Fax
+98 21 8822 0052
Email
gshafiee.endocrine@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Tarbiat Modares
Full name of responsible person
Amir Abdollahzadeh
Street address
Tarbiat Modares University, Jalal Al Ahmad, Nasr Bridge
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Fax
+98 21 8288 3101
Email
Res@modares.ac.ir
Web page address
https://res.modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tarbiat Modares
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Research Institute of Endocrinology and Metabolism, Tehran Faculty of Medical Sciences
Full name of responsible person
azadeh shahbazi
Street address
Endocrinology and Metabolism Research Institute, Next to Shariati Hospital, Jalal Al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713119
Phone
+98 21 8863 1298
Fax
+98 21 8822 0052
Email
azadehshahbazi1392@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute of Endocrinology and Metabolism, Tehran Faculty of Medical Sciences
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Motahare Ababaf Behbahani
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Fax
+98 21 8800 6544
Email
m.behbahani@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sahar Boozari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Fax
+98 21 8800 6544
Email
s.boozari@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sahar Boozari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Fax
+98 21 8800 6544
Email
s.boozari@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared when the subjects be made unidentifiable.
When the data will become available and for how long
The access phase starts six months after the results publication
To whom data/document is available
Researchers in academic and research organizations will have access to the data.
Under which criteria data/document could be used
To do scientific research
From where data/document is obtainable
Sahar Boozari, Adress: Tarbiat Modares University; Jalal Al Ahmad Highway; Email: s.boozari@modares.ac.ir; Phone number: 00982182885053
What processes are involved for a request to access data/document
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.