The Effects of Multi-Component Exercise Training on Selected Intestinal Microbiomes, and Disease Status and Their Relationship with Cognitive Function in Elderly People with Type 2 Diabetes
Determining the relationship between gut bacteria changes and inflammatory indices with cognitive performance after a multiple exercise training course in the elderly with type 2 diabetes.
Design
The clinical trial has a control group without any intervention of 50 people, an intervention group of 50 people, phase 4 on 100 patients, sealed envelopes are used for randomization.
Settings and conduct
The field of the current study will be sports training and counseling for women with type 2 diabetes. After being diagnosed by telephone, the subjects will appear fasting in the pre- and post-test stages at Tarbiat Modares University. Exercises will be presented to the exercise group in the form of booklets and educational videos, and the coach will contact the patients of the exercise group every week to follow up on the exercises. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria : people with type 2 diabetes, age in the range of 50-75 years, Glaciated hemoglobin more than 6.5
Exclusion criteria: having heart and joint problems so that they are not able to perform the sports training protocol. Taking nerve pills and sleeping pills, having orthopedic problems
Intervention groups
50 people in the sports training group and 50 people in the control group without training intervention
The Effects of Multi-Component Exercise Training on Selected Intestinal Microbiomes, and Disease Status and Their Relationship with Cognitive Function in Elderly People with Type 2 Diabetes
Public title
the effect of exercise on cognitive functions and gut microbiom
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
type 2 diabetes
Age range 50-75 years
Exclusion criteria:
Severe orthopedic or respiratory problems
Severe cardiovascular patients
Dementia
Central nervous system disorders
A special diet such as vegetarianism
Carrying out a regular exercise program during the last 6 months
Age
From 50 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be determined by the random block method with blocks of 4 and using the random number table of the random allocation software. Blocking and allocation sequence will be done for concealment by a person not involved in the research (allocation concealment). The allocation ratio of the samples will be one to one and they will be placed in two sports intervention and control groups. Then, based on the obtained blocks and according to the allocation sequence, the multiple exercise training program will be given to the exercise intervention group. Blinding will not occur in this study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کارگروه کمیته اخلاق در پژوهش دانشگاه تربیت مدرس
Street address
Jalal ale Ahmad
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2022-08-27, 1401/06/05
Ethics committee reference number
IR.MODARES.REC.1401.113
Health conditions studied
1
Description of health condition studied
TYPE 2 DIABETES
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications
Primary outcomes
1
Description
Examining intestinal microbiome factors such as Lactobacillus bacteria due to diabetes -
Timepoint
Measurement of stool microbiomes before the intervention and 12 weeks after the intervention
Method of measurement
Through stools of patients and extraction of DNA from stools by Fioragin kit
Secondary outcomes
1
Description
Executive function
Timepoint
Before and after 3 months intervention
Method of measurement
Trail Making Test
2
Description
Respiratory and cardiovascular system, blood circulation and muscle
Timepoint
Trail Making Test
Method of measurement
6-Minute Walk Test
3
Description
Body Mass Index
Timepoint
6-Minute Walk Test
Method of measurement
Weight in kilograms divided by the square of height in meters
Intervention groups
1
Description
Intervention group: implementation of 12 weeks of combined sports training intervention that includes aerobic and strength training, balance, flexibility and cognitive training. The training will start from 3 days a week and will reach 5 days from the 9th week to the end of the 12th week, which includes walking. It is accompanied by cognitive exercises and weight or resistance exercises and yoga movements for balance and stretching the body.
Category
Other
2
Description
Control group: NO EXERCISE
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Research Institute
Full name of responsible person
Dr. Azam Kohkan
Street address
GOLZAR
City
TEHRAN
Province
Tehran
Postal code
1665659911
Phone
+98 21 2356 2000
Email
inf@royan.org
Web page address
http://royan.org
2
Recruitment center
Name of recruitment center
Endocrine and Metabolism Research Institute
Full name of responsible person
Dr. Hossein Adib
Street address
ENGHELAB
City
TEHRAN
Province
Tehran
Postal code
1411713119
Phone
+98 21 8880 8005
Email
dmclinic@tums.ac.ir
Web page address
http://emri.tums.ac.ir/DMC2/Home
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Mahdieh Melanori Shamsi
Street address
JALAL E ALE AHMAD
City
TEHRAN
Province
Tehran
Postal code
1411713116
Phone
+98 21 82880
Email
pres@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
TARBIAT MODARES UNIVERSITY OF TEHRAN
Proportion provided by this source
10
Public or private sector
Public
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
Tarbiat Modares University of Tehran
Full name of responsible person
Dr. Mahdieh Melanori Shamsi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
JALALE AL AHMAD
City
TEHRAN
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4683
Email
molanouri@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Mahdieh Melanori Shamsi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
JALAL E ALE AHMAD
City
TEHRAN
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4683
Email
molanouri@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
ALIEH VAHED
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
JALAL E ALE AHMAD
City
TEHRAN
Province
Tehran
Postal code
1411713116
Phone
82880 21 0098
Email
alieh.vahed@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data related to the main outcome can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
People approved by the supervisor
Under which criteria data/document could be used
For the purpose of additional research in the field of the present study
From where data/document is obtainable
supervisor
What processes are involved for a request to access data/document
E-mail correspondence with the supervisor molanouri@modares.ac.ir