Determining the effect of 12 weeks of submaximal aerobic training (swimming) on aerobic capacity and heart rate variability in girls with thalassemia major.
Design
The present study is a quasi-experimental study with parallel groups in which the allocation to intervention and control groups was non-randomized; the sample size included 30 girls with thalassemia major (10 in each group) and 15 healthy girls as the control group; this study was not blinded and did not have a trial phase because it is a non-randomized intervention study.
Settings and conduct
This study will be conducted to investigate the effect of exercise training on cardiovascular indices in patients with thalassemia major in Hamedan province. The method of implementation will include the evaluation of HRV indices and echocardiography before and after the exercise intervention. Due to the nature of the intervention (exercise in water), blinding was not performed in this study
Participants/Inclusion and exclusion criteria
The study includes girls aged 20 to 35 with a history of thalassemia major for more than 10 years, but those with neuropathy, cerebrovascular or ocular disorders, cardiorespiratory failure, high blood pressure, or taking medications that affect resting heart rate are excluded from the study
Intervention groups
The control group receives no intervention, the control group continues to take Desferal, and the experimental group participates in water aerobics in addition to Desferal.
Main outcome variables
Changes in HRV indices (time and frequency-based); Changes in structural and functional echocardiographic indices of the heart; Predictive model of the function of the cardiac autonomic system based on ECG and ECHO indices.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260209068813N1
Registration date:2026-02-28, 1404/12/09
Registration timing:retrospective
Last update:2026-02-28, 1404/12/09
Update count:0
Registration date
2026-02-28, 1404/12/09
Registrant information
Name
Tayyebe Baghian
Name of organization / entity
The university of bu-ali sina
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 9057
Email address
t.baghian@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-22, 1404/06/31
Expected recruitment end date
2025-12-20, 1404/09/29
Actual recruitment start date
2025-09-22, 1404/06/31
Actual recruitment end date
2025-12-05, 1404/09/14
Trial completion date
empty
Scientific title
The effect of 12 weeks of submaximal aerobic training (swimming) on aerobic capacity and heart rate variability in girls with thalassemia major
Public title
The effect of submaximal aerobic exercise on cardiac factors in patients with thalassemia major
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with thalassemia major
Women with thalassemia major should have no history of heart disease
Exclusion criteria:
Patients are able to do exercise
Non-smoking by the aforementioned patients
Individuals with neuropathy, cerebrovascular or ocular disorders, cardiorespiratory failure, high blood pressure, or taking medications that affect resting heart rate were excluded from the study.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Our study is a quasi-experimental design with non-random group assignment, no possibility of blinding, using a control group for comparison, and with sampling limitations.In this study, for the first time, the simultaneous effect of submaximal aerobic exercise (swimming) on changes in heart rate and cardiac structure and function has been investigated
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Floor 5, Central Headquarters of the University of Medical Sciences, Shahid Fahmideh Blvd., Pohachouz Square, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517733497
Approval date
2025-01-19, 1403/10/30
Ethics committee reference number
IR.BASU.REC.1403.028
Health conditions studied
1
Description of health condition studied
Cardiac factors in thalassemia major patients
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Detailed changes in HRV indices (SDNN, RMSSD, 5SDANN, PNN50 HF, LF, (VLF, LF / HF) and echocardiographic indices (LV- AO- LA- RV- FS- EF- MPI- PWTS-PWTD- IVSTS- IVSTD) from the beginning of the study to the end of the intervention
Timepoint
HRV, echocardiography, and blood factors were measured in the pre-test, one week after the last blood transfusion, and in the post-test, 48 hours after the end of the training intervention.
Method of measurement
HRV was measured using a Holter monitoring device, and cardiac structure and function were measured using echocardiography.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Thalassemia major exercise (3 days a week for 12 weeks of submaximal aerobic exercise and water rehabilitation), exercise duration will range from 20 to 60 minutes, and the exercise will begin with an intensity of 40% of the heart rate and will gradually increase to 75% of the heart rate in the twelfth week (the intensity of the exercise will be proportional to the patients' ability).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan Children's Hospital
Full name of responsible person
Dr. Maryam Nikofar
Street address
Taleqani Blvd
City
Hamadan
Province
Hamadan
Postal code
6517733497
Phone
+98 81 3838 9057
Email
Baghian.t@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of bu-ali Sina
Full name of responsible person
Sayyidah Manijeh Arabi
Street address
Shahid Mustafa Ahmadi Roshan's, Chaharbagh
City
Hamadan
Province
Hamadan
Postal code
6517733497
Phone
+98 81 3838 9057
Email
Baghian.t@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of bu-ali Sina
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of bu-ali Sina
Full name of responsible person
Farzad Nazem
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Cardiovascular physiology
Street address
Shahid Mustafa Ahmadi Roshan's Chaharbagh
City
Hamadan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3140 0000
Email
farzadnazem2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of bu-ali Sina
Full name of responsible person
Farzad Nazem
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Cardiovascular physiology
Street address
Shahid Mustafa Ahmadi Roshan's Chaharbagh
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۹۵
Phone
+98 81 3140 0000
Email
farzadnazem2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of bu-ali Sina
Full name of responsible person
Tayyebe Baghian
Position
student
Latest degree
Master
Other areas of specialty/work
Sports physiology
Street address
Shahid Mustafa Ahmadi Roshan's Chaharbagh
City
Hamadan
Province
Hamadan
Postal code
6517733497
Phone
+98 81 3838 9057
Email
baghian.t@gmail.com
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
I will preferably make a decision after carefully examining the aspects and consulting with other members of the research team