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Effect of concurrent aerobic- resistance training on aerobic power, heart structure and function, heart rate variables, galectin-3 and N-terminal pro-brain natriuretic peptide in patients with chronic heart failure

Protocol summary

Study aim
the effect of a period of aerobic exercise on aerobic power, heart structure and function, heart rate variables, galectin-3 and NT proBNP in patients chronic heart failure With grade II-III NYHA classification.
Design
A clinical trial with a control group, 40 patients are selected in two groups of simple randomized in patients with Class II-III New York Heart Association(NYHA) of classification of heart failure with EF> 20%.
Settings and conduct
The present research is a semi-experimental study on patients with heart failure hospitalized in Hashamat Hospital in Rasht and referring to the specialized clinic of this hospital, after the introduction of cardiologists will participate in exercise training three days a week for 8 weeks.6-minute walk test, blood sampling and echocardiography is performed before and after eight weeks of training.
Participants/Inclusion and exclusion criteria
40 patients are included with a range of 52 to 78 years of age, II-III cardiac failure with a ejection fraction of more than 20% in the study. Patients are not included with psychiatric and nervous disorders treated with tranquilizers, orthopedic, speaking and hearing problems in the study.
Intervention groups
The control group receives the usual treatment and care that the hospital has in its work schedule. The experimental group, in addition to the usual treatment, performs regular exercises, including: eight weeks, three times a week for 60 to 90 minutes a day, progressive aerobic exercises with 60-90% of maximum heart rate, resistance training with intensity 70-50% one maximal repeat, walking 4 sessions per week with average intensity 70 -50% maximum resting heart rate
Main outcome variables
aerobic power, heart structure and functional, heart rate variables, galectin-3 and N-terminal pro-brain natriuretic peptide(NT Pro-BNP)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150531022498N24
Registration date: 2018-07-25, 1397/05/03
Registration timing: registered_while_recruiting

Last update: 2018-07-25, 1397/05/03
Update count: 0
Registration date
2018-07-25, 1397/05/03
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
2018-06-05, 1397/03/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of concurrent aerobic- resistance training on aerobic power, heart structure and function, heart rate variables, galectin-3 and N-terminal pro-brain natriuretic peptide in patients with chronic heart failure
Public title
The effect of exercise training on chronic heart failure patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic heart failure in NYHA II-III Classification with ejection fraction(EF) > 20%
Exclusion criteria:
Patients with NYHA IV class Patients with acute myocarditis Patients with disorder exercise (such as severe aortic stenosis, severe hypertrophic cardiomyopathy (HOCM), etc.) Patients are not able to perform 6MWT ''. For example, osteoarthritis, knee surgery, cerebrovascular infarct , and so on Patients with specific cognitive impairment Patients with psychiatric and nervous disorders who are being treated with sedative medicines Patients with orthopedic, verbal and auditory problems
Age
From 52 years old to 78 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random, Among the candidates who are qualified, the lottery method is performed after a justification session and expressing the possible benefits and disadvantages
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
4147654919
Approval date
2018-02-10, 1396/11/21
Ethics committee reference number
IR.IAU.RASHT.REC.1396.101

Health conditions studied

1

Description of health condition studied
Chronic Heart Failure
ICD-10 code
I50.0
ICD-10 code description
Congestive heart failure, Congestive heart disease Right ventricular failure (secondary to left heart failure)

Primary outcomes

1

Description
galectin-3
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Serum level by ELISA method(n mol/ ml)

2

Description
N-terminal pro-brain natriuretic peptide
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Serum level by ELISA method(n mol/ ml)

3

Description
Aerobic Power
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Maximum heart rate, 6-Minute Walk Test(6MWT)

4

Description
Structure and function of heart
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Echocardiography

5

Description
Heart rate variables
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Maximum heart rate

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Aerobic training and concurrent resistance for eight weeks and three days a week, 60 minutes a day that progressive aerobic exercise with 60 to 90 percent of maximum heart rate at rest and strength by 60 to 85% of one repetition maximum
Category
Prevention

2

Description
Control group: Without intervention
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Heshmat Hospital
Full name of responsible person
Zahra Mahmoodi
Street address
15 Khordad Avenue , Dr Heshmat Hospital
City
Rasht
Province
Guilan
Postal code
41446-83499
Phone
+98 13 3336 4861
Email
Shabani@iaurasht.ac.ir

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 Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3336 4861
Email
shabani_msn@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
zahra mahmoodi
Position
PHD 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
4147654919
Phone
+98 13 3336 4861
Email
fmahmoodi1390@Gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ramin Shabani
Position
Associate professore
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
4147654919
Phone
+98 13 3336 4861
Email
shabani_msn@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Mahmoodi
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
4147654919
Phone
+98 13 3336 4861
Email
fzmahmoodi@yahoo.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
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