Protocol summary

Study aim
1.Evaluate effects of 8-week aerobic exercise on cardiac function in elderly men post-myocardial infarction. 2.Assess effects of 8-week aerobic-resistance exercise on cardiac function in the same group. 3.Compare effects of aerobic vs. aerobic-resistance exercise on cardiac variables in elderly men after myocardial infarction
Design
This applied, semi-experimental study uses a pre-post design to compare the effects of aerobic and aerobic-resistance training on cardiovascular outcomes in men with coronary artery disease.
Settings and conduct
The study is conducted at Modares Hospital, Tehran, on men aged 45–65 with coronary artery disease. After medical clearance, the training and assessments are carried out before and after the 8-week intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Men 45-65 years, healthy or with coronary artery disease/post-heart procedures, medically cleared, non-smokers, and no recent alcohol use. Exclusion Criteria: Cardiac warning signs during exercise, chronic disabling diseases, or lower limb disabilities preventing exercise.
Intervention groups
Aerobic Group:3 weekly sessions of aerobic exercise (cycling, elliptical) at 50–80% max heart rate with warm-up and cool-down, intensity increasing over 8 weeks; vital signs monitored. Aerobic-Resistance Group:Same aerobic protocol plus 2 weekly resistance sessions (30–50% 1RM, 12–15 reps).
Main outcome variables
Systolic Blood Pressure, 2. Diastolic Blood Pressure, 3. Resting Heart Rate, 4. Left Ventricular Systolic Function, 5. Cardiac Capacity and Performance

General information

Reason for update
Acronym
Cardiac Rehabilitation/Secondary Prevention (CRSP)
IRCT registration information
IRCT registration number: IRCT20250603066054N1
Registration date: 2025-06-20, 1404/03/30
Registration timing: prospective

Last update: 2025-06-20, 1404/03/30
Update count: 0
Registration date
2025-06-20, 1404/03/30
Registrant information
Name
Heydar Sadeghi
Name of organization / entity
Department of Biomechanics and Sports Injury, Faculty of Physical Education and Sports Sciences, Kha
Country
Iran (Islamic Republic of)
Phone
+98 912 245 3175
Email address
h.sadeghi@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-06, 1404/04/15
Expected recruitment end date
2025-09-01, 1404/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effectiveness of Two Cardiac Rehabilitation Approaches in Middle-Aged and Elderly Men with Coronary Artery Disease
Public title
Considering the effect of Two Cardiac Rehabilitation Approaches in Middle-Aged and Elderly Men with Coronary Artery Disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Middle-aged men (45-65 years) with myocardial infarction Physician’s approval for participation in the exercise program Non-smokers No alcohol consumption
Exclusion criteria:
Presence of warning signs during exercise Unstable angina pectoris Dyspnea at rest or severe arrhythmias Chronic diseases causing discomfort during exercise ST segment elevation or depression on ECG during exercise Respiratory disturbances during exercise Inability or unwillingness to complete the exercise program
Age
From 45 years old to 65 years old
Gender
Male
Phase
2
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
This study used a randomized controlled trial design. Thirty-two men with coronary artery disease were randomly assigned to two intervention groups: aerobic training and concurrent (combined) training. Participants were stratified by age (middle-aged and elderly) and then randomly allocated within each stratum using a simple randomization method. Randomization was conducted by an independent researcher using a random number table. Allocation concealment was maintained through coded identifiers, and outcome assessors were blinded to group assignments.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the intervention (supervised exercise training), blinding of participants, care providers, and investigators was not feasible. However, outcome assessors and data analysts were blinded to group allocation to minimize detection and analysis bias. This single-blind approach helped ensure objectivity in data evaluation and result interpretation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kharazmi University Ethics Committee
Street address
Kharazmi University, Shahid Haghani Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15719-14911
Approval date
2025-06-01, 1404/03/11
Ethics committee reference number
IR.KHU.REC.1404.039

Health conditions studied

1

Description of health condition studied
Cardiovascular disease including myocardial infarction in men aged 45 to 65
ICD-10 code
ICD-10: I2
ICD-10 code description
Ischemic heart diseases (I20–I25)

Primary outcomes

1

Description
Primary outcomes include changes in systolic and diastolic blood pressure, resting heart rate, left ventricular ejection fraction, and cardiac capacity and performance as assessed by stress testing, measured before and after the 8-week intervention.
Timepoint
Primary outcome variables will be measured at two time points: baseline (before the intervention) and immediately after the 8-week exercise program.
Method of measurement
Systolic Blood Pressure: Measured using a blood pressure monitor in mmHg.Diastolic Blood Pressure: Measured using a blood pressure monitor in mmHg.Resting Heart Rate: Measured by counting heartbeats per minute at rest.Left Ventricular Systolic Function: Calculated by echocardiography using ejection fraction (stroke volume/end-diastolic volume).Cardiac Capacity and Performance: Assessed using a cardiac stress test (exercise test).

Secondary outcomes

empty

Intervention groups

1

Description
Aerobic Exercise Group:Three weekly sessions of aerobic training including warm-up, main activities (cycling and elliptical at 50–80% max heart rate), and cool-down, with gradual increase over 8 weeks.Aerobic-Resistance Exercise Group:Same aerobic protocol plus two weekly resistance training sessions targeting major muscle groups at 30–50% one-rep max, 12–15 reps.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Modares Hospital
Full name of responsible person
Reza Arefizadeh
Street address
Army University of Medical Sciences (AJA), Shahid Etemadzadeh St, West Fatemi Ave, Tehran 14356, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 912 928 2729
Email
r.arefizadeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Self-funded by the investigators
Full name of responsible person
Heydar Sadeghi
Street address
Faculty of Physical Education and Sport Sciences, Kharazmi University, End of Southern Razan (Shahid Hessari) Street, next to Shahid Keshvari Sports Complex, Mohseni (Mirdamad) Square, Mirdamad Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3311115447
Phone
+98 912 245 3175
Fax
Email
h.sadeghi@khu.ac.ir
Web page address
Grant name
Supervisor’s funding
Grant code / Reference number
none
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Supervisor’s funding
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Heydar.Sadeghi
Position
Full Professor
Latest degree
Subspecialist
Other areas of specialty/work
Department of Biomechanics and Sports Pathology
Street address
Faculty of Physical Education and Sport Sciences, Kharazmi University, End of Southern Razan (Shahid Hessari) Street, next to Shahid Keshvari Sports Complex, Mohseni (Mirdamad) Square, Mirdamad Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3311115447
Phone
0212228001
Email
h.sadeghi@khu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Heydar Sadeghi
Position
Full professor
Latest degree
Subspecialist
Other areas of specialty/work
2. Department of Biomechanics and Sports Pathology
Street address
Faculty of Physical Education and Sport Sciences, Kharazmi University, End of Southern Razan (Shahid Hessari) Street, next to Shahid Keshvari Sports Complex, Mohseni (Mirdamad) Square, Mirdamad Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3311115447
Phone
+98 21 2222 8001
Email
h.sadeghi@khu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Heydar Sadeghi
Position
Full professor
Latest degree
Subspecialist
Other areas of specialty/work
2. Department of Biomechanics and Sports Pathology
Street address
Faculty of Physical Education and Sport Sciences, Kharazmi University, End of South Razan Street (Shahid Hesari), near Shahid Keshvari Sports Complex, Mirdamad Boulevard, Mohseni Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1544733111
Phone
+98 21 2222 8001
Email
h.sadeghi@khu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Title: Clinical Trial Data on Cardiac Rehabilitation in Middle-Aged and Elderly Men with Coronary Artery Disease Details: This dataset includes de-identified participant data collected during pre- and post-intervention phases of the cardiac rehabilitation study, including demographic information, physiological measurements (blood pressure, heart rate, echocardiography results), and exercise protocol details.
When the data will become available and for how long
The data will be available starting 6 months after the publication of the study results. The dataset will remain accessible for a minimum of 5 years through an online data repository.
To whom data/document is available
Available to researchers upon request
Under which criteria data/document could be used
The data will be available for academic and research purposes only. Users must agree to a data use agreement ensuring confidentiality and ethical use. Access to the data will be granted after approval by the principal investigator. Additional note: If the journal requests, the data and related documents will be made available to the journal editors and reviewers upon reasonable request to verify the study findings.
From where data/document is obtainable
Data and documents will be available from the corresponding author upon reasonable request.
What processes are involved for a request to access data/document
Interested researchers should submit a formal request via email to the corresponding author detailing the purpose of data use. The request will be reviewed by the principal investigator for approval. Upon approval, a data use agreement ensuring confidentiality and ethical use must be signed. After completing these steps, access to data/documents will be granted.
Comments
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