1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effect of aerobic training time (morning and evening) on the cognitive and physiological characteristics of the elderly with type 2 diabetes

Protocol summary

Study aim
Investigating the effect of 12 weeks of aerobic exercise in morning and evening on cognitive function and the predictor axis of Alzheimer's disease in elderly people with type 2 diabetes
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, on 45 patients.
Settings and conduct
All subjects will complete the written consent form and cooperation in the research before entering the study. Before and after the training session, physical fitness tests, anthropometry, cognitive performance and blood tests are taken from all participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria include having type 2 diabetes for more than five years, age range of 60-65 years, not suffering from a specific disease that interferes with doing sports, not suffering from severe depression due to the effect of mood changes and depression. In the memory tests, for the same reason, the depression test (Beck) will be taken from the subjects, and people with a score higher than 13 will not be included in the study (a score higher than 13 is a sign of depression. Also, a sedentary lifestyle and the ability to perform sports movements. Exclusion criteria will include injury and inability to perform exercise programs.
Intervention groups
The statistical population will include all women with type 2 diabetes with an average age of 60 ± 5.07 years who have a medical file in Shahrekord Diabetes Association. Sampling will be done based on a call from eligible women with type 2 diabetes and will be selected based on the available population.
Main outcome variables
Investigating the difference in the effect of aerobic activity in morning and evening on short-term memory in elderly people with type 2 diabetes Investigating the difference in the effect of aerobic activity in morning and evening on executive performance in elderly people with type 2 diabetes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181212041935N1
Registration date: 2024-02-18, 1402/11/29
Registration timing: retrospective

Last update: 2024-02-18, 1402/11/29
Update count: 0
Registration date
2024-02-18, 1402/11/29
Registrant information
Name
Azra Mohammadpanah Ardakan
Name of organization / entity
Ardakan University
Country
Iran (Islamic Republic of)
Phone
+98 35 3224 3027
Email address
azramohammadpanah@ardakan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-19, 1402/09/28
Expected recruitment end date
2024-02-17, 1402/11/28
Actual recruitment start date
2023-12-19, 1402/09/28
Actual recruitment end date
2024-02-17, 1402/11/28
Trial completion date
2024-02-17, 1402/11/28
Scientific title
Comparison of the effect of aerobic training time (morning and evening) on the cognitive and physiological characteristics of the elderly with type 2 diabetes
Public title
Comparison of the effect of aerobic training time (morning and evening) on the cognitive and physiological characteristics of the elderly with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria include having type 2 diabetes for more than five years, age range of 60-65 years, not suffering from a specific disease that interferes with doing sports, not suffering from severe depression due to the effect of mood changes and depression. In the memory tests, for the same reason, the depression test (Beck) will be taken from the subjects, and people with a score higher than 13 will not be included in the study (a score higher than 13 is a sign of depression (Kudreti et al., 2022). Also, a sedentary lifestyle and the ability to perform sports movements.
Exclusion criteria:
Exclusion criteria will include injury and inability to perform exercise programs.
Age
From 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
blocked randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yazd University Research Ethics Committee
Street address
Ardakan University, Ardakan
City
Ardakan
Province
Yazd
Postal code
9549189518
Approval date
2023-07-15, 1402/04/24
Ethics committee reference number
IR.YAZD.REC.1402.044

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Having type 2 diabetes for more than five years, not suffering from severe depression
Timepoint
before the start of the intervention and 12 weeks after the start of the intervention
Method of measurement
Before and after the training session, physical fitness tests, anthropometry, cognitive performance and blood tests are taken from all participants.

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: aerobic exercise in the morning
Category
Treatment - Other

2

Description
The second intervention group: aerobic exercise in the evening
Category
Treatment - Other

3

Description
Control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord Diabetes Association
Full name of responsible person
Alireza Badri - security officer
Street address
Shahrekord Medical University
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
Phone
+98 38 3333 0061
Email
azramohammadpanah@ardakan.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The Iran National Science Foundation (INSF)
Full name of responsible person
President
Street address
No. 33, No. 33, 5th St., above Jalal Al Ahmad Intersection, North Kargar St., Tehran
City
Tehran
Province
Tehran
Postal code
1439634665
Phone
+98 21 8216 1000
Email
info@insf.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Iran National Science Foundation (INSF)
Proportion provided by this source
100
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
Ardakan University
Full name of responsible person
Azra Mohammadpanah Ardakan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Khatami Blvd
City
Ardakan
Province
Yazd
Postal code
8951895491
Phone
+98 35 3224 3027
Fax
Email
azramohammadpanah@ardakan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardakan University
Full name of responsible person
Azra Mohammadpanah Ardakan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Khatami Blvd
City
Ardakan
Province
Yazd
Postal code
8951895491
Phone
+98 35 3224 3027
Fax
Email
azramohammadpanah@ardakan.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ardakan University
Full name of responsible person
Azra Mohammadpanah Ardakan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Khatami Blvd
City
Ardakan
Province
Yazd
Postal code
8951895491
Phone
+98 35 3224 3027
Fax
Email
azramohammadpanah@ardakan.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
The information and part of the data from the main outcome will be published in the form of articles extracted from the trial.
When the data will become available and for how long
After printing the results as an article
To whom data/document is available
For researchers working in academic and scientific institutions and people who are also engaged in industry
Under which criteria data/document could be used
In organizations with similar intervention work, they can get guidance from the results and process of this research and experiment.
From where data/document is obtainable
Researcher azramohammadpanah@ardakan.ac.ir
What processes are involved for a request to access data/document
After reviewing the request and going through the legal procedures of publishing information
Comments
Loading...