Investigation and comparison of clinical status improvement following an exercise rehabilitation period in cardiac patients after right coronary artery (RCA) or left anterior descending coronary artery (LAD) angioplasty.
This research aims to compare the effectiveness of a sports rehabilitation course on improving the clinical condition in cardiac patients who have experienced coronary artery angioplasty.
Design
Non-randomized trial with non-blinded postoperative care and outcome assessment. Trial with a parallel group design of 30 patients, enrolled between July 2023 and September 2023.
Settings and conduct
A clinical trial will involve an 8-week rehabilitation program at Hamedan Farshchian Hospital's Cardiac Rehabilitation Center. Participants will attend three sessions per week for a total of 24 sessions.
Participants/Inclusion and exclusion criteria
Two groups of 15 patients will be studied after performing right coronary artery (RCA) and left coronary artery (LAD) angioplasty, who refer to the cardiac rehabilitation department of Farshchian Heart and Vascular Hospital in Hamedan.
Intervention groups
Training session includes aerobic exercise based on individual capacity, followed by light resistance exercises using body weight and dumbbells. Cooling down at the end helps prevent reflexes. It is necessary to explain that in the aerobic training section, each person will train with a treadmill, foot ergometer, and manual ergometer.
Main outcome variables
Quality of Life, Respiratory efficiency, Cardiovascular function, Prevalence rate of myocardial infarction, coronary angioplasty, angina pectoris, and Coronary artery reocclusion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230501058035N1
Registration date:2023-05-23, 1402/03/02
Registration timing:prospective
Last update:2023-05-23, 1402/03/02
Update count:0
Registration date
2023-05-23, 1402/03/02
Registrant information
Name
Ramin Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 939 013 1815
Email address
raminmn4@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-21, 1402/03/31
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation and comparison of clinical status improvement following an exercise rehabilitation period in cardiac patients after right coronary artery (RCA) or left anterior descending coronary artery (LAD) angioplasty.
Public title
Investigation improvement following an exercise rehabilitation period in cardiac patients after angioplasty.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have undergone coronary artery angioplasty and refer to the cardiac rehabilitation department
Exclusion criteria:
The patient has not undergone valve repair surgeries.
Absence of severe heart failure.
Absence of movement problems and debilitating environmental joint diseases, and severe skeletal disorders
Absence of debilitating cognitive disorders
No history of heart or thorax surgery
Not involving more than one coronary vessel in angioplasty
No history of congenital heart problems
The patient does not have pericardial perfusion experience.
Age
From 40 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not 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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh st, Hamadan, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2023-05-11, 1402/02/21
Ethics committee reference number
IR.UMSHA.REC.1401.475
Health conditions studied
1
Description of health condition studied
cardiac patients after coronary artery
ICD-10 code
Z95.5
ICD-10 code description
Presence of coronary angioplasty implant and graft
Primary outcomes
1
Description
The percentage of heart patients who underwent coronary artery angioplasty.
Timepoint
The systolic and diastolic function of the heart's left ventricle will be measured in two stages (before the beginning of the training period and after its completion).
Method of measurement
Using an echocardiography device using the Simpson method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The said test consists of seven stages of three minutes. The first stage starts with a treadmill slope of 10%, and in each stage, 2% is added to the slope. Also, the treadmill's speed in the first stage is 2.74 km/h, which increases increasingly in the later stages. In sports training sessions, each session will begin with a standard warm-up phase, which includes 5 minutes of light-intensity activity and static and dynamic stretching exercises. The main part of the training session consists of two separate parts. In the aerobic exercise section, each person exercises with moderate intensity (Met 3-6 or pressure perception scale 12-13 on the 15-value Borg scale) according to his maximum aerobic capacity obtained in the test. In the second part of the training session, after the aerobic exercise, light resistance exercises using body weight and dumbbells are performed for the patients by the physiotherapist. At the end of the training session, cooling is adopted to prevent parasympathetic reflexes. It is necessary to explain that in the aerobic training section, each person will train alternately in three sessions a week with a treadmill, foot ergometer, and manual ergometer. The exercises will be carried out three days a week and finally for eight weeks.
Category
Rehabilitation
2
Description
Intervention group: The said test consists of seven stages of three minutes. The first stage starts with a treadmill slope of 10%, and in each stage, 2% is added to the slope. Also, the treadmill's speed in the first stage is 2.74 km/h, which increases increasingly in the later stages. In sports training sessions, each session will begin with a standard warm-up phase, which includes 5 minutes of light-intensity activity and static and dynamic stretching exercises. The main part of the training session consists of two separate parts. In the aerobic exercise section, each person exercises with moderate intensity (Met 3-6 or pressure perception scale 12-13 on the 15-value Borg scale) according to his maximum aerobic capacity obtained in the test. In the second part of the training session, after the aerobic exercise, light resistance exercises using body weight and dumbbells are performed for the patients by the physiotherapist. At the end of the training session, cooling is adopted to prevent parasympathetic reflexes. It is necessary to explain that in the aerobic training section, each person will train alternately in three sessions a week with a treadmill, foot ergometer, and manual ergometer. The exercises will be carried out three days a week and finally for eight weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiology subspecialty medical center Farshchian
Full name of responsible person
Amirhossein Yazdi
Street address
Shahid Fahmideh Ave., Hamadan Town, Iran
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1740
Email
hcvc@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
School of Health, Health Sciences Research Center, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 4058
Email
reza.shokohi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
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
Hamedan University of Medical Sciences
Full name of responsible person
Amir Hossein Yazdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Farshchian Cardiovascular Subspecialty Medical Center, Shahid Fahmideh Ave, Hamadan City, Iran
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1740
Email
amirhoseyn.yazdi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Lobat Majidi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Farshchian Cardiovascular Subspecialty Medical Center, Shahid Fahmideh Ave, Hamadan City, Iran
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 918 315 8983
Email
l.majidi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Shaghaghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Farshchian Cardiovascular Subspecialty Medical Center, Shahid Fahmideh Ave, Hamadan City, Iran
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1740
Email
z.shaghaghi@umsha.ac.ur
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Only a part of the data, such as the information related to the main outcome or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Our data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Our data will be available to all scientific researchers who request via official email.
From where data/document is obtainable
z.shaghaghi@umsha.ac.ur via email
What processes are involved for a request to access data/document
Researchers will receive the data by sending a data access request six months after the article's publication by sending an email to z.shaghaghi@umsha.ac.ur.