Protocol summary

Summary
The purpose of this study is to reduce aggravating factors of heart failure with exercise training. patients are randomly selected. A clinical trial study of the most important aggravating factors, MI, renal, pulmonary, diabetes and hypertension was determined. 38 Patients of Heart Failure with grade II-III ,in the age range of 40-70 years are divided into intervention and control groups. The patients develops symptoms of heart failure, arrhythmia, ischemia and HTN crisis, they are excluded from the study. And patients with neurological, orthopedic, speech and hearing problems are not included in the study. In the intervention group, a 8-week of training program is performed to Pre-exercise with warm-up, and cool down post-exercise for 5 to 10 minutes. Twice a week treadmill with an intensity of 70-60% maximum heart rate in 20 minutes, Arm ergometer for 3 minutes in the first week and 6 minutes in the last week, Incentive spirometry 10 minutes for 3 days a week, 30 minute walking exercises, Weighing for 30 minutes and 10-15 times at the start of week with 30-40% 1RM for hand weights and 50-60% 1RM for foot weights in two sets with 5 minutes rest between the two sets, red resistance band in the first two weeks with 10-8 repeats, green color for the third to fifth week with 12-10 repeats, and blue color from 6 to 8 weeks with 15-12 repeats and 5 minutes of rest between the two sets. Measurment tools are ECG, pulseoxymeter, echocardiography, CXR, 6-minute test, Peak Flowmeter, Spirometry, Blood test before and after exercise.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017070534911N1
Registration date: 2017-07-18, 1396/04/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-18, 1396/04/27
Registrant information
Name
Zahra Mahmoodi
Name of organization / entity
Heshmat Hospital/Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3366 9064
Email address
gicrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of effect of 8 weeks of exercise training on The most common aggravating factors of heart failure patients
Public title
The effect of exercise exercises on heart failure patient
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:The age range40-70 years; with II, III grade heart failure ; patient with the most important aggravating factors including kidney, lung, diabetes and hypertension difficulties Exclusion criteria: :Exacerbation of heart failure symptoms; arrhythmia ; ischemic ; HTN crisis; Psychiatric problem;orthopedic problem; speech problem; hearing problem
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
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 Guilan University of Medical Sciences
Street address
Shahid Beheshti freeway
City
Rasht
Postal code
4193893345
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.GUMS.REC.1396.107

Health conditions studied

1

Description of health condition studied
Heart Failure
ICD-10 code
I50.0
ICD-10 code description
Congestive heart disease

Primary outcomes

1

Description
Lung volume In the intervention group
Timepoint
Before and after 8 weeks of exercise training
Method of measurement
spirometry

2

Description
Lung Volume In the control group
Timepoint
Before and 8 weeks After the start of the study
Method of measurement
Spirometry

3

Description
Lung capacity In the intervention group
Timepoint
Before and 8 weeks after exercise training
Method of measurement
spirometry

4

Description
Function and structure of the heart include: LVEF left ventricular fraction (%), systolic ending volume (ESV) and diastolic end volume (EDV)
Timepoint
before and after 8 weeks of exercise training
Method of measurement
Echocardiogaphy

5

Description
Heart Rate
Timepoint
before and after of 8 week
Method of measurement
Pulseoximeter

6

Description
Blood Pressure
Timepoint
before and after of 8 weeks of exercise training
Method of measurement
pressure indicator

7

Description
cr(Creatine Blood)
Timepoint
before and after 8 weeks of exercise training
Method of measurement
Blood Test

8

Description
potency function
Timepoint
before and after 8 weeks of exercise training
Method of measurement
6-minute test

9

Description
HDL, LDL
Timepoint
before and after 8 weeks of exercise training
Method of measurement
Blood test

10

Description
BSو HbA1C
Timepoint
before and after 8 weeks of exercise training
Method of measurement
Blood Test

11

Description
Lung capacity In the controlgroup
Timepoint
before and 8 week After the start of the study
Method of measurement
Spirometry

12

Description
Blood Pressure in the control group
Timepoint
before and 8 week After the start of the study
Method of measurement
pressure indicator

13

Description
Cr(cratinine Blood) in the control group
Timepoint
before and 8 week After the start of the study
Method of measurement
Blood Test

14

Description
Heart rate in the control group
Timepoint
before and 8 week After the start of the study
Method of measurement
pulseoximetry

15

Description
potency function in the control group
Timepoint
before and 8 week After the start of the study
Method of measurement
6 minute test

16

Description
HDL, LDL Blood in the control group
Timepoint
before and 8 week After the start of the study
Method of measurement
Blood Test

17

Description
HbA1C, BS in the control group
Timepoint
before and 8 week After the start of the study
Method of measurement
Blood Test

18

Description
Function and structure of the heart include: LVEF left ventricular fraction (%), systolic ending volume (ESV) and diastolic end volume (EDV) in the control group
Timepoint
Before and 8 weeks After the start of the study
Method of measurement
EchoCardiography

Secondary outcomes

1

Description
Cardiac arrhythmia
Timepoint
During the exercise
Method of measurement
manitoring

2

Description
Ischemia
Timepoint
During the exercise
Method of measurement
manitoring

3

Description
HTN crisis
Timepoint
By indication symptoms
Method of measurement
pressure indicator

Intervention groups

1

Description
Intervention group: How to exercise sports interventions In the test group, that is For 8 weeks, 2 times a week for 30 minutes of treadmill, Then, the Arm ergometer first started for 3 minutes and up to 8 weeks to 6 minutes, then 10 minutes of incentive spirometry will be done. In addition, 3 times a week for a 30 minute walking, Then, for 30 minutes, the weight of the hand and foot should be repeated 10-15 times in two sets with 5 minutes of rest between the two sets, After that, for 30 minutes, the theraband (elastic band) is performed at the beginning of low resistance and then with medium resistance. In the exercise with weight and theraband, changes in any organ or repeat exercises, rest was considered for 2 minutes. Before and after the exercises, they will be warmed and cooled for 10-5 minutes.
Category
Rehabilitation

2

Description
Control group: There is no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Heshmate Hospital
Full name of responsible person
Zahra Mahmoodi
Street address
15 Khordad Street- Heshmat Hospital
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chanceller for Research of Guilan University of Medical Sciences
Full name of responsible person
Shademan Nehmati
Street address
Shahid Beheshti freeway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanceller for Research of Guilan University of Medical Sciences
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
Guilan Guilan University of Medical Sciences
Full name of responsible person
Zahra Mahmoodi
Position
Ph.D Student in Sports Physiology / Nurse of responsible for patient education
Other areas of specialty/work
Street address
15 khordad Street- Heshmat Hospital
City
Rasht
Postal code
4193713194
Phone
+98 133366906466
Fax
+98 13 3366 8718
Email
gicrc@gums.ac.irfzmahmoodi@yahoo.comfmahmoodi1390@gmail.com
Web page address
http://heshmat.gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Zahra Mahmoodi
Position
Exercise Physiology of Masters
Other areas of specialty/work
Street address
15 Khordad Street- Heshmat Hospital
City
Rasht
Postal code
4193713194
Phone
+98 133366906466
Fax
+98 13 3366 8718
Email
gicrc@gums.ac.irfzmahmoodi@yahoo.comfmahmoodi1390@gmail.com
Web page address
http://heshmat.gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Zahra Mahmoodi
Position
Ph.D Student in Sports Physiology / Nurse of responsible for patient education
Other areas of specialty/work
Street address
15 khordad street- Heshmat Hospital
City
Rasht
Postal code
4193713194
Phone
+98 133366906466
Fax
+98 33668718
Email
gicrc@gums.ac.irfzmahmoodi@yahoo.comfmahmoodi1390@gmail.com
Web page address
http://heshmat.gums.ac.ir

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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