A Comparison of the Effects of Eight Weeks of Combined Exercise Training with Two Different Intensities on Attentional Networks, Blood-Brain Barrier-Related Factors, and Explicit Motor Memory in Older Women with Type 2 DiabetesResearch ethics committi of Lourestan univercity
the effectiveness of eight weeks of combined resistance–endurance training at two different intensities on cognitive function and the modulation of biomarkers associated with astrocytic injury, blood–brain barrier dysfunction, and neuroinflammation in older women with type 2 diabetes mellitus
Design
This study is designed as a three-arm, parallel-group randomized controlled trial with pre- and post-intervention assessments to investigate the effects of eight weeks of combined exercise training at different intensities on cognitive function and biomarkers associated with astrocytic injury, blood–brain barrier dysfunction, and neuroinflammation in older women with type 2 diabetes mellitus.
Settings and conduct
this study will be conducted in Chaharmahal and Bakhtiari Province, Iran, at facilities equipped to perform the exercise interventions, cognitive assessments, and laboratory analyses.
Participants/Inclusion and exclusion criteria
Inclusion criteria
A confirmed diagnosis of type 2 diabetes mellitus (T2DM) by a physician.
HbA1c ≥ 6.5% and fasting blood glucose (FBG) ≥ 126 mg/dL.
Current treatment with oral antidiabetic medications.
No regular participation in structured exercise during the previous six months.
No use of medications known to affect cognitive function or memory.
Exclusion criteria included:
Musculoskeletal injuries
Neurological disorders or chronic inflammatory diseases
Intervention groups
Combined Hypertrophy Resistance Training plus Aerobic Endurance Training group
Combined Muscular Endurance Resistance Training plus Aerobic Endurance Training group
Active control group
Main outcome variables
Combined aerobic exercise and hypertrophy resistance training (HRT)
Combined aerobic exercise and muscular endurance resistance training (ERT)
Aerobic exercise (AET)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260714070191N1
Registration date:2026-07-27, 1405/05/05
Registration timing:prospective
Last update:2026-07-27, 1405/05/05
Update count:0
Registration date
2026-07-27, 1405/05/05
Registrant information
Name
Razieh Kooshki
Name of organization / entity
Lorestan University
Country
Iran (Islamic Republic of)
Phone
+98 916 856 8557
Email address
kooshki.r@lu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-09-02, 1405/06/11
Expected recruitment end date
2026-09-21, 1405/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of the Effects of Eight Weeks of Combined Exercise Training with Two Different Intensities on Attentional Networks, Blood-Brain Barrier-Related Factors, and Explicit Motor Memory in Older Women with Type 2 DiabetesResearch ethics committi of Lourestan univercity
Public title
Effects of Exercise on Cognitive Factors in Elderly Women with Diabetes
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Participants must have a physician-confirmed diagnosis of type 2 diabetes mellitus, HbA1c ≥ 6.5%, fasting blood glucose (FBG) ≥ 126 mg/dL (7.0 mmol/L), and be receiving oral antidiabetic medication.
Exclusion criteria:
Age
From 60 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the nature of the exercise intervention, blinding of participants and exercise trainers is not feasible. However, outcome assessors (responsible for cognitive, laboratory, and functional measurements) and data analysts will be blinded to participants’ group allocation. The group assignment information will be maintained by the principal investigator.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lorestan University Research Ethics Committee
Street address
Golshan 2 Street
City
Khorramabad
Province
Lorestan
Postal code
6814988156
Approval date
2025-11-19, 1404/08/28
Ethics committee reference number
IR.UL.REC.1404.001
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10.4
ICD-10 code description
Type 1 diabetes mellitus with neurological complications
2
Description of health condition studied
Diabetes
ICD-10 code
E10.4
ICD-10 code description
Type 1 diabetes mellitus with neurological complications
Primary outcomes
1
Description
AQP4 (Aquaporin-4)
Timepoint
Study Start and End Dates
Method of measurement
Using specialized laboratory kits
2
Description
Calpain
Timepoint
Study Start and End Dates
Method of measurement
kit
3
Description
GFAP
Timepoint
Study Start and End Dates
Method of measurement
kits
4
Description
S100B
Timepoint
Study Start and End Dates
Method of measurement
kit
Secondary outcomes
empty
Intervention groups
1
Description
Hypertrophy Resistance Training Group
Category
Treatment - Other
2
Description
Intervention group: Endurance Resistance Training Group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز بهزیستی شهرستان فارسان
Full name of responsible person
زهرا همتی
Street address
No. 1, Alley 4, North Farabi Street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815716891
Phone
+98 913 772 8628
Email
zhemati@ardakan.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Science Foundation of Iran (INSF)
Full name of responsible person
Razieh Kooshki
Street address
Golshan 2 Street
City
Khorramabad
Province
Lorestan
Postal code
6814988156
Phone
+98 916 856 8557
Email
kooshki.razieh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Science Foundation of Iran (INSF)
Proportion provided by this source
100
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
دانشگاه اردکان
Full name of responsible person
Zahra Hemati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 1, Alley 4, North Farabi Street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815716891
Phone
0989137728628
Email
zhemati@ardakan.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Ardakan
Full name of responsible person
Zahra Hemati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 1, Alley 4, North Farabi Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815716891
Phone
+98 913 772 8628
Email
zhemati@ardakan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardakan University
Full name of responsible person
zahra hemati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 1, Alley 4, North Farabi Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815716891
Phone
+98 913 772 8628
Email
zhemati@ardakan.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more information
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study results and data will only be published in the form of a scientific article.
When the data will become available and for how long
There is no specific time frame
To whom data/document is available
Researchers
Under which criteria data/document could be used
The data may be made available for research purposes at the discretion of the Principal Investigator.
From where data/document is obtainable
Principal Investigator (PI)
What processes are involved for a request to access data/document
The data will be made available for research purposes upon submission of a formal and well-justified request to the Principal Investigator (PI).