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The effect of a selected exercise course on physical and cognitive function and some factors affecting cognition in elderly women with type 2 diabetes

Protocol summary

Study aim
The effect of a combined exercise training on physical fitness, cognitive function and glycemic control indices in women with type 2 diabetes
Design
The subjects were voluntarily selected and randomly divided into two groups of 12 (experimental and control), of which three in the control group withdrew for personal reasons, and finally 12 in the experimental group and 9 in the control group until the end of the study.
Settings and conduct
From people with diabetes in Sabzevar city who are 55 to 65 years old and . The study was performed for 3 months 3 days a week in Chamran Sports Hall located in Sabzevar city. Exercises were performed in three ways: aerobic, balance and strength
Participants/Inclusion and exclusion criteria
having type 2 diabetes for more than five years, age range 55-65 years, not having a specific disease that conflicts with exercise, not having severe depression due to the effects of mood swings and depression In memory tests, subjects were tested for depression (Beck) and subjects with a score higher than 13 were not included in the study (a score greater than 13 is a sign of depression) (Kokok 2013), literacy , Was sedentary lifestyle and ability to do sports. Exclusion criteria include absenteeism for more than three consecutive or seven non-consecutive sessions, injury, and inability to perform training programs
Intervention groups
The study consisted of two groups of exercise and control. The exercise group received combined exercise (aerobic, strength and balance) for 3 months 3 days a week and the control group did not receive exercis
Main outcome variables
Measurement of physical function (static dynamic balance, muscle strength, vo2max) Measuring cognitive function Measurement of cognitive blood indices related to cognition (bdnf, irisin, hemoglobin a1c, blood sugar)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220112053699N1
Registration date: 2022-01-18, 1400/10/28
Registration timing: retrospective

Last update: 2022-01-18, 1400/10/28
Update count: 0
Registration date
2022-01-18, 1400/10/28
Registrant information
Name
nafiseh Ghodrati
Name of organization / entity
Hakim sabzevari university
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 9128
Email address
nafise.ghodrati@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-04-30, 1398/02/10
Actual recruitment start date
2019-05-20, 1398/02/30
Actual recruitment end date
2019-05-20, 1398/02/30
Trial completion date
2019-10-07, 1398/07/15
Scientific title
The effect of a selected exercise course on physical and cognitive function and some factors affecting cognition in elderly women with type 2 diabetes
Public title
The Effect of Exercise on Physical and Cognitive Function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria include having type 2 diabetes for more than five years, age range 65-55 years, not having a specific disease that is inconsistent with exercise, not having severe depression due to the effects of mood swings and depression In memory tests, subjects were tested for depression (Beck) and people with a score higher than 13 were not included in the study (a score higher than 13 is a sign of depression), literacy, sedentary lifestyle And was the ability to perform sports movements
Exclusion criteria:
Exclusion criteria include absenteeism for more than three consecutive or seven non-consecutive sessions, injury, and inability to perform training programs.
Age
From 55 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. After determining the sample size using Cochran software, 24 people were included in the study according to the inclusion criteria and then 11 people were selected by lot for the control group and 13 people for the exercise group. Eventually, one person from the training group and two people from the control group gave up.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
دانشگاه حکیم سبزواری
Street address
tohid shahr sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
5465-7767-8889
Approval date
2019-04-30, 1398/02/10
Ethics committee reference number
IR.HSU.REC.1398.007

Health conditions studied

1

Description of health condition studied
type 2 diabetes
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Physical Function - Cognitive Function - Levels of Blood Factors bdnf Irisine Hemoglobin a1c Blood Glucose
Timepoint
Three months later the intervention currency
Method of measurement
Measuring Cognitive Function Using Moka Questionnaire - Measuring Physical Function Using Rickley-Jones Tests - Measuring Blood Indices Using Special Blood Kits

Secondary outcomes

1

Description
Long-term memory score. Information processing score
Timepoint
tthree month
Method of measurement
Long-term memory using forward digit width test. Data processing using symbol and digit testing

Intervention groups

1

Description
Intervention group:
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
HESHMATIYE HOSPITAL
Full name of responsible person
AKRAM FAGHIHI
Street address
HAJ MOLA HADI SCOU
City
SABZEVAR
Province
Razavi Khorasan
Postal code
2392-3424-4234
Phone
+98 51 4464 9128
Email
name@domain.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
hakim sabzevari university
Full name of responsible person
دکتر امیر حسین حقیقی
Street address
tohid shahr, hakim sabzevari university
City
sabzevar
Province
Razavi Khorasan
Postal code
3565-7787-798
Phone
+98 51 4401 8798
Email
nafise.ghodrati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
hakim sabzevari university
Proportion provided by this source
20
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
hakim sabzevari university
Full name of responsible person
nafiseh ghodrati
Position
student
Latest degree
Master
Other areas of specialty/work
Others
Street address
sabzevar simetri daneshghah.
City
sabzevar
Province
Razavi Khorasan
Postal code
8768-76786-798
Phone
+98 51 4464 9128
Email
nafise.ghodrati@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
hakim sabzevari university
Full name of responsible person
nafise ghodrati
Position
student
Latest degree
Master
Other areas of specialty/work
Others
Street address
sabzevar si metri daneshgah
City
sabzevar
Province
Razavi Khorasan
Postal code
8869-7878-890
Phone
+98 51 4464 9128
Email
nafise.ghodrati@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
the hakim sabzevari university
Full name of responsible person
nafiseh ghodrati
Position
student
Latest degree
Master
Other areas of specialty/work
Others
Street address
sabzevar si metri daneshaghah
City
sabzevar
Province
Razavi Khorasan
Postal code
8979-7090-7998
Phone
+98 51 4464 9128
Email
nafise.ghodrati@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All the information obtained in this study can be published after statistical analysis and unidentifiable individual
When the data will become available and for how long
1401
To whom data/document is available
free
Under which criteria data/document could be used
Any use of published statistical analyzes is unrestricte
From where data/document is obtainable
Email the responsible author
What processes are involved for a request to access data/document
An email to the responsible author will be answered within a week
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