Purpose of this study is to determine the effect of one session of Aerobic Discontinuous Training protocol with 65% heart rate reserve intensity on Hepcidin and plasma Ferritin in patients with Beta Thalassemia Intermedia.This study is semi-experimental with the experimental and control groups that will be run as pre and post-test.Twenty Beta Thalassemia Intermedia patients with Ejection fraction higher than 55%, and lower pulmonary artery pressure of 30 mm Hg and no history of heart disease with irregular blood transfusions or no blood transfusions will take part in this study.After determine eligibility for patients entry in study, in the form who are fasting refer to lab to take prototype. After that the patients take part in 10 minutes warm up include general and special movements such as running and Stretching. Then, each patient in the form single will done 3 period of 10 minutes running with 5 minutes of disabled rest between each period that monitor with cardiac screening to run with 65% heart rate reserve. Immediately and 3 hours after the workout the next blood samples will be obtained.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062516211N2
Registration date:2015-07-11, 1394/04/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-11, 1394/04/20
Registrant information
Name
Majid Mohabbat
Name of organization / entity
Education
Country
Iran (Islamic Republic of)
Phone
+98 28 3334 9035
Email address
m.mohabbat@srttu.edu
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical sciences and State Resources
Expected recruitment start date
2015-07-01, 1394/04/10
Expected recruitment end date
2015-08-01, 1394/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of one session of Aerobic Discontinuous Training protocol on Hepcidin and plasma Ferritin in patients with Beta Thalassemia Intermedia
Public title
The effect of exercise on main iron regulator hormone in patients with Beta Thalassemia Intermedia
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
1-Patients with Beta Thalassemia Intermedia.
2-Irregular blood transfusions or no blood transfusions.
3-Ejection Fraction more than 55%.
4-Pulmonary artery pressure or (PAP) less than of 30 mm Hg.
5-Lack of Hemochromatosis.
6-The absence of fractures in lower limbs.
7-Lack of diabetes.
Exclusion criteria:
1-Regular blood transfusions.
2-Iron overload in the heart.
3-Splenectomized patients.
4-Drugs such as Digoxin and other drugs associated with heart disease.
5-Personal desire, nausea, vomiting and headache during exercise.
Age
From 31 years old to 48 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
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
Baqiyatallah University of Medical sciences
Street address
Baqiyatallah University of Medical Sciences,Vanak Square, Sheikh Bahaii St, Tehran, Iran
City
Tehran
Postal code
Iran
Approval date
2014-11-02, 1393/08/11
Ethics committee reference number
340/5/5904/س
Health conditions studied
1
Description of health condition studied
Beta Thalassemia Intermedia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia
Primary outcomes
1
Description
Hepcidin
Timepoint
Before, immediately after and 3 hours after the intervention.
Method of measurement
Blood sample and ELISA method
2
Description
Ferritin
Timepoint
Before, immediately after and 3 hours after the intervention.
Method of measurement
Blood sample and Photometric method
Secondary outcomes
1
Description
24-hour dietary recall
Timepoint
24 hour before primary blood sample
Method of measurement
By 24-hour dietary recall questionnaire
2
Description
Blood pressure
Timepoint
Before and after each period of practice
Method of measurement
By manual manometer and according to mm Hg
3
Description
RPE or Rate of Perception Effort
Timepoint
Before and after each period of practice
Method of measurement
20-point Borg questionnaire
Intervention groups
1
Description
Control Group will be among those who did not have regular physical activity in the past six months.
Category
N/A
2
Description
The exercise group after the 10-minute warm-up in three 10-minute periods with 65% heart rate reserve run on the treadmill. Before and after each 10-minute period RPE is measured by using the Borg index.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Zafar Adult Thalassemia Clinic
Full name of responsible person
Azita azarkeivan
Street address
No. 1 Shariati St., St. Zafar, north of M. Nasiri Street in Front of shahin St,Zargandeh Plumbing,Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Exercise Physiology Research Center,Baqiyatallah University of Medical Sciences Baqiyatallah
Full name of responsible person
Vahid Sobhani
Street address
Baqiyatallah University of Medical Sciences,Vanak Square, Sheikh Bahaii St, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Exercise Physiology Research Center,Baqiyatallah University of Medical Sciences Baqiyatallah
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences,Exercise Physiology Research Center
Full name of responsible person
Vahid Sobhani
Position
Head of Department/Ph.D
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences,Vanak Square, Sheikh Bahaii St, Tehran, Iran
City
Tehran
Postal code
Iran
Phone
+98 21 8248 2391
Fax
Email
Sobhani518@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Education
Full name of responsible person
Majid Mohabbat
Position
Master of science
Other areas of specialty/work
Street address
No. 40, Nazeri Alley, Rah Ahan st., Qazvin, Iran
City
Qazvin
Postal code
3416879469
Phone
+98 28 3355 6082
Fax
Email
M.Mohabbat@srttu.edu
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Education
Full name of responsible person
Majid Mohabbat
Position
Master of Science
Other areas of specialty/work
Street address
No. 40 , Nazeri Alley, Rah Ahan st., Qazvin, Iran
City
Qazvin
Postal code
3416879469
Phone
+98 28 3355 6082
Fax
Email
M.Mohabbat@srttu.edu
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)