Study of the effect of resistance-aerobic training on cardiovascular index, quality of life, body composition and physical fitness in beta thalassemia major patients
Assessing the effect of resistance- aerobic training on cardiovascular index, quality of life, body composition and physical fitness in beta thalassemia major patients
Design
Randomize clinical trail with parallel groups, non blinded, conducted between April and June of 2016
Settings and conduct
This clinical trial study was conducted between April and June of 2016 in Thalassemia department of Shahid Amini hospital of Langarud and the participants were randomly divided into two experimental and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient with beta thalassemia major disease, whom have regular blood transfusion, as well as a history of Desferal usage (19–25 years)
Exclusion criteria: have an acute heart disease and any abnormalities, which can limit exercise
Intervention groups
Experimental group: in addition to the usual treatment, they will be done 2-3 sessions of incremental resistance- aerobic training per week for six weeks
Control group: only the usual treatment will be done for them
Main outcome variables
Cardiovascular index; quality of life; body composition; physical fitness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150531022498N19
Registration date:2018-03-18, 1396/12/27
Registration timing:retrospective
Last update:2018-03-18, 1396/12/27
Update count:0
Registration date
2018-03-18, 1396/12/27
Registrant information
Name
Ramin Shabani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2715
Email address
shabani@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-02-19, 1394/11/30
Expected recruitment end date
2016-03-09, 1394/12/19
Actual recruitment start date
2016-02-19, 1394/11/30
Actual recruitment end date
2016-03-09, 1394/12/19
Trial completion date
empty
Scientific title
Study of the effect of resistance-aerobic training on cardiovascular index, quality of life, body composition and physical fitness in beta thalassemia major patients
Public title
Resistance-aerobic training in beta thalassemia major patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have beta thalassemia major disease
Have regular blood transfusion
19–25 years using of Desferal
Exclusion criteria:
Absence for more than three exercise sessions
Have acute heart disease
Musculoskeletal abnormalities or any other medical condition that can contribute to exercise limitation
Age
From 16 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of samples to experimental and control groups- Lottery
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
Ethics Committee of Islamic Azad University Rasht Branch
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Approval date
2016-09-17, 1395/06/27
Ethics committee reference number
IR.IAU.RASHT.REC.1395.29
Health conditions studied
1
Description of health condition studied
Patient with beta thalassemia major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Cardiovascular index
Timepoint
Before and 24 hours after the end of intervention
Method of measurement
Using by measuring heart rate, QTc distance, end systolic volume, end diastolic volume and ejection fraction
2
Description
Quality of life
Timepoint
Before and after the end of intervention
Method of measurement
Using by quality of life questionnaire (SF-36)
Secondary outcomes
1
Description
Body composition
Timepoint
Before and after the end of intervention
Method of measurement
Using by measuring body mass index and fat percent
2
Description
Physical fitness
Timepoint
Before and after the end of intervention
Method of measurement
Using by measuring maximum oxygen consumption (VO2max) and muscle endurance
Intervention groups
1
Description
Intervention group: doing six weeks, 2-3 time per week incremental resistance- aerobic training
Category
Other
2
Description
Control group: no intervention will be conducted
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Amini Hospital
Full name of responsible person
Seyedeh Fatemeh Banihashemi Bazarzadeh
Street address
Shahid Amini Hospital, Imam Khomeini Street, Langarud, Guilan Province
City
Langarud
Province
Guilan
Postal code
-
Phone
+98 13 4252 4005
Email
shabani_msn@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Delpasand
Street address
Islamic Azad University Rasht Branch, Taleshan Bredge
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3343 0503
Email
shabani_msn@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
personality, Researcher
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedeh Fatemeh Banihashemi Bazarzadeh
Position
MA
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3343 0503
Email
shabani_msn@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ramin Shabani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3343 0503
Email
shabani_msn@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Izaddoust
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3385 6174
Email
fa.izaddoust@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available