Protocol summary

Summary
Objectives:Telomeres are structures at the ends of DNA and protect chromosome ends. this study will investigate the effect of concurrent training on telomere length in Patients with Myocardial infarction. Design: this study is a Quasi-experimental pre-post intervention study. Setting and conduct: twenty male patients from Taleghani Hospital selected and randomly will assigned to training group (n=10) or control group (n=10). Training protocol will be eight weeks of concurrent training, 3 time pre week. Blood samples will be taken half hour before first training session and 24 hours after last training session. Inclusion criteria : stable of patient's condition; quitting smoking and alcohol during the study. Exclusion criteria : unstable pectoral angina; decompensated heart failure. Intervention: rehabilitation training (concurrent training). main outcome measures (variables): Telomere length; Telomerase activity; TRF1; TRF2.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015112225188N1
Registration date: 2016-03-21, 1395/01/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-21, 1395/01/02
Registrant information
Name
Behzad Saki
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 361 7803
Email address
b_saki@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-12-21, 1393/09/30
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
clinical trial : The effect of concurrent training on telomere length in patients with myocardial infarction
Public title
Concurrent training and telomere length in patients with myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : passing four to eight weeks since occurrence of myocardial infarction; stable of patient's condition; quitting smoking and alcohol during the study. Exclusion criteria : unstable pectoral angina; decompensated heart failure; ventricular arrhythmia; orthopedic problems.
Age
From 50 years old to 60 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 20
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
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo Boulevard, Velenjak, Tehran
City
Tehran
Postal code
Approval date
2016-01-24, 1394/11/04
Ethics committee reference number
IR.SBMU.RAM.REC.1394.485

Health conditions studied

1

Description of health condition studied
myocardial infarction
ICD-10 code
121.0
ICD-10 code description
Acute transmural myocardial infarction of anterior wall Transmural infarction (acute)(of): anterior (wall) NOS anteroapical anterolateral anteroseptal

Primary outcomes

1

Description
telomere length
Timepoint
pre-post test
Method of measurement
telomere length- quantitative polymerase chain reaction (qPCR)- t/s

2

Description
Telomerase activity
Timepoint
pre-post test
Method of measurement
Telomerase activity- quantitative polymerase chain reaction (qPCR)- t/s

3

Description
trf1
Timepoint
pre-post test
Method of measurement
trf1-Immunosorbent Assay (ELISA) -pg/ml

4

Description
trf2
Timepoint
pre-post test
Method of measurement
trf1-Immunosorbent Assay (ELISA) -pg/ml

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Intervention group: The training group will perform an 8-week exercise training protocol in three sessions per week.
Category
Rehabilitation

2

Description
Control group: The subjects in the control group will continue their daily lives during this period and wont carry out any exercise training.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran's Taleghani hospital
Full name of responsible person
Amirhossein Abedi Yekta
Street address
Tehran's Taleghani hospital, Daneshjoo Boulevard, Velenjak, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Behzad Saki
Street address
Tehran's Taleghani hospital, Daneshjoo Boulevard, Velenjak, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University
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
Shahid Beheshti University
Full name of responsible person
Behzad Saki
Position
phD
Other areas of specialty/work
Street address
No. 2, Khorram 1 alley, Kashani street, Aleshtar
City
Aleshtar
Postal code
Phone
+98 66 3252 0120
Fax
Email
b_saki@sbu.ac.ir; b.saki@ut.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Behzad Saki
Position
phD
Other areas of specialty/work
Street address
No. 2, Khorram 1 alley, Kashani street, Aleshtar
City
Aleshtar
Postal code
Phone
+98 66 3252 0120
Fax
Email
b_saki@sbu.ac.ir; b.saki@ut.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Behzad saki
Position
PhD
Other areas of specialty/work
Street address
No. 2, Khorram 1 alley, Kashani street, Aleshtar
City
Aleshtar
Postal code
Phone
+98 66 3252 0120
Fax
Email
b_saki@sbu.ac.ir; b.saki@ut.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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