Protocol summary

Summary
Objective:The effect of upper limb exercise on outcomes of myocardial infarction patient’s at Velayat medical center. Main inclusion criteria: Age of 45-65, Diagnosis of myocardial infarction according to the cardiologist, 14 to 21 days from the time of discharging,Ejection Fraction of left ventricular >30% according of Echo in the file, Unsuccessful primary PTCA, Type of Uncomplicated cardiac infarction except for a extensive myocardial infarction, Ability to exercise according to the cardiologist. Main exclusion criteria: Suffering of disease of moderate to severe cardiac valve,Uncontrolled Tachycardia of ventricular and auricular, Angina pectoris or typical chest pain while doing the exercise, BP Systolic>140 before exercise, BP Diastolic>90 before exercise, BP Systolic< 100 before exercise, BP Diastolic< 60 before exercise, Myocarditis or Pericarditis, Thrombophlebitis, Moderate to Severe COPD according of cardiologist,Severe Kidney failure or severe disease according of cardiologist, Anemia(Heb <10), Extensive myocardial infarction, Successful primary PCI, Musculoskeletal problems. Participants: Sum of 54 patients with myocardial infarction admitted to CCU and the internal part of the heart selected by random sampling method and will be divided into two groups: Control and intervention.Interventions: In the control group, routine care was performed in all the centers and the quality of life questionnaire was initially admitted and after six weeks, and the referral to the physician was completed after six weeks from the date of infection. In the intervention group, in addition to routine care, upper limb exercise will be performed twice a week for six weeks and 40 minutes every 9 to 10 hours, the intervention will be 5 minutes Warm up and 30 minutes of upper limb exercise and 5 minutes Cooling will be done at the end of the session.Each session of vital signs was recorded before and after the intervention, and the quality of life questionnaire was completed in the first and last session, and the check list of readmission and referral to the physician were completed in the last session.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017100936674N1
Registration date: 2017-11-16, 1396/08/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-16, 1396/08/25
Registrant information
Name
Maryam Joodaki
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
m.joodaki@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of upper extremity exercise on the outcomes of myocardial infarction
Public title
Effect of upper limb exercise on the outcomes of patients with myocardial infarction
Purpose
Supportive
Inclusion/Exclusion criteria
Entry criteria: Age of 45-65, Diagnosis of myocardial infarction according to the cardiologist, 14 to 21 days from the time of discharging, Ejection Fraction of left ventricular >30% according of Echo in the file, Unsuccessful primary PTCA, Type of Uncomplicated cardiac infarction except for a extensive myocardial infarction, Ability to exercise according to the cardiologist. Exit criteria: Suffering of disease of moderate to severe cardiac valve, Uncontrolled Tachycardia of ventricular and auricular,Angina pectoris or typical chest pain while doing the exercise,BP Systolic>140 before exercise, BP Diastolic>90 before exercise, BP Systolic< 100 before exercise, BP diastolic< 60 before exercise, Myocarditis or Pericarditis, Thrombophlebitis, Moderate to Severe COPD according of cardiologist, Severe Kidney failure or severe disease according of cardiologist, Anemia(Heb <10), Extensive myocardial infarction, Successful primary PCI, Musculoskeletal problems
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences;Shahid Bahonar Boulevard;
City
Qazvin
Postal code
3419759811
Approval date
2017-05-13, 1396/02/23
Ethics committee reference number
IR.QUMS.REC.1396.110

Health conditions studied

1

Description of health condition studied
Myocardial Infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction

Primary outcomes

1

Description
Quality of life
Timepoint
Before and after intervention
Method of measurement
Questionnaire

2

Description
Readmission
Timepoint
After the intervention
Method of measurement
check list

3

Description
Refer to doctor
Timepoint
After the intervention
Method of measurement
check list

Secondary outcomes

empty

Intervention groups

1

Description
present study is a semi-tentative research in form of clinical trial and random assignation of participants into two groups Case and Control. I n this study, in addition to routine care, upper limb exercise will be performed twice a week for six weeks and 40 minutes each session.The intervention is 5 minutes warm up, then 30 minutes of upper limb exercise and 5 minutes cooling.Selected patients patients will do twice a week every 9 -10 in the morning, for six weeks. Before and after the intervention, vital signs were recorded and the quality of life questionnaire was completed before intervention and at the end of the intervention, a check list for referral to the physician and readmission at the end of the intervention were completed.
Category
Rehabilitation

2

Description
Control group: In this study, the control group received the usual care, and also recorded vital signs, completing the quality of life questionnaire, and a check list for readmission and referral to the physician.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Maryam Joodaki Master student of intensive care nursing
Street address
Qazvin- minoodar- Elaheye- 22 bahman- Velayat hospital
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Maryam Joodaki
Full name of responsible person
Maryam Joodaki
Street address
Plaque 13;Second Street;Shaghayegh Street;Iranpars Highway;Janat Abad Shomali;Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Maryam Joodaki
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
Qazvin University of Medical Sciences
Full name of responsible person
Maryam joodaki
Position
Master student of intensive care nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery; Qazvin University of Medical Sciences; Shahid Bahonar Boulevard;Qazvin
City
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Fax
+98 28 3323 7268
Email
"m.joodaki@qums.ac.ir" "maryam_joodaki@yahoo.com"
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Leili Yekefallah
Position
PHD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery; Qazvin University of Medical Sciences; Shahid Bahonar Boulevard; Qazvin
City
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Fax
+98 28 3323 7268
Email
"leili_fallah@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Maryam Joodaki
Position
Master student of intensive care nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery; Qazvin University of Medical Sciences; Shahid Bahonar Boulevard; Qazvin
City
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Fax
+98 28 3323 7268
Email
"m.joodaki@qums.ac.ir" "maryam_joodaki@yahoo.com"
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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