The purpose of this research is to investigate the effect of resistance exercise with low load to concentric failure and resistance exercise with high load on hemodynamic response in coronary artery patients.
Design
The design of the current research is a randomized, crossover clinical trial
Settings and conduct
Patients referred to Noor Heart Heart Center in Rasht, perform initial measurements during one session and two types of resistance exercises with two different intensities and repetitions during two sessions.
Participants/Inclusion and exclusion criteria
Age range 50-70 years
Patients with a history of angioplasty
Occlusion of one to three coronary vessels
Patients with a history of rehabilitation exercises
Relative cardiorespiratory fitness (METs more than 5 and oxygen consumption equivalent to 18 ml/kg/minute)
no significant change in the ejection fraction
No cardiac arrhythmia
No musculoskeletal injury
Intervention groups
Low load resistance exercise group (40% of one repetition maximum to concentric failure)
High load resistance exercise group (70% of one repetition maximum, 10 repetitions)
Main outcome variables
Hemodynamic variables including rate pressure product, systolic and diastolic blood pressure, heart rate and Perceived exertion in response to these two types of resistance exercises to determine the safety of exercises to failure (low load, high repetition) compared to the traditional form of exercises (high load and low repetition) ) are measured.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180205038626N14
Registration date:2024-03-02, 1402/12/12
Registration timing:prospective
Last update:2024-03-02, 1402/12/12
Update count:0
Registration date
2024-03-02, 1402/12/12
Registrant information
Name
Zahra Ahmadnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
zahmadnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-09, 1402/12/19
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Hemodynamic response to low load to concentric failure resistance exercise and high load resistance exercise in coronary artery disease patients
Public title
Hemodynamic response to low load to failure resistance exercise and high load in coronary artery disease patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with coronary artery disease
Patients with a history of angioplasty and occlusion between one and three coronary arteries
Relative cardiorespiratory fitness (METs more than 5 and oxygen consumption equivalent to 18 ml/kg/minute)
No significant change in the ejection fraction variable according to the opinion of a specialist doctor
Not having cardiac arrhythmia with the opinion of a specialist doctor
No musculoskeletal injury or arthritis
Not having diabetes
Exclusion criteria:
Patients who do not have a history of resistance training (untrained)
Patients who have not reached relative compatibility in cardio-respiratory factors
Diabetic patients
Patients with arrhythmia and patients who have not reached stable conditions in terms of hemodynamics
Age
From 50 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethnic committees of university of guilan
Street address
5th Kilometer of Persian Gulf Highway, Rasht, Guilan Province, Iran
City
Rasht
Province
Guilan
Postal code
۴۱۹۹۶۱۳۷۷۶
Approval date
2023-11-08, 1402/08/17
Ethics committee reference number
IR.GUILAN.REC.1402.054
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Rate pressure product
Timepoint
At the beginning of the study or at rest, immediately after doing the exercise, 3 minutes after doing the exercise
Method of measurement
The Rate pressure product is determined by systolic blood pressure and heart rate. An analog sphygmomanometer is used to measure systolic blood pressure and a portable ECG device is used to measure heart rate.
Secondary outcomes
1
Description
Systolic blood pressure
Timepoint
At rest, immediately after exercise and 3 minutes after exercise
Method of measurement
Using an analog pressure gauge
2
Description
Diastolic blood pressure
Timepoint
At rest, immediately after exercise and 3 minutes after exercise
Method of measurement
Using an analog pressure gauge
3
Description
Heart rate
Timepoint
At rest, immediately after exercise and 3 minutes after exercise
Method of measurement
Using a portable ECG device
4
Description
Perceived Exertion
Timepoint
immediately after exercise
Method of measurement
Borg Rating of Perceived Exertion Scale (1-10)
Intervention groups
1
Description
Intervention group: Low-load to concentric failure resistance exercise
Category
Rehabilitation
2
Description
Intervention group: high-load resistance exercise
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
The Noor heart center
Full name of responsible person
Dr. payam saidie
Street address
Moalem St, Noor specialist heart clinic
City
Rasht
Province
Guilan
Postal code
۴۱۵۳۸۹۳۸۴۸
Phone
+98 13 9100 4044
Email
info@noor-hc.com
Web page address
https://noor-hc.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The university of guilan
Full name of responsible person
Dr. Payam saidie
Street address
5th Kilometer of Persian Gulf Highway, Rasht, Guilan Province, Iran
City
Rasht
Province
Guilan
Postal code
۴۱۹۹۶۱۳۷۷۶
Phone
+98 13 3369 0274
Email
int@guilan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of guilan
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
university of guilan
Full name of responsible person
Adel ghorbani
Position
Master's student in Applied exercise Physiology
Latest degree
Master
Other areas of specialty/work
Others
Street address
5th Kilometer of Persian Gulf Highway, Rasht, Guilan Province, Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
01333690274-8
Email
adel.ghorbani.pe@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university of guilan
Full name of responsible person
Payam Saidie
Position
Assistant Professor of the Department of Sports Physiology, Faculty of Sports Sciences, Gilan Univer
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
رشت، بزرگراه خلیج فارس، کیلومتر ۵ جاده تهران، مجتمع دانشگاه گیلان
City
Rasht
Province
Guilan
Postal code
۴۱۹۹۶۱۳۷۷۶
Phone
+98 13 3369 0274
Email
payam.saidie@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra Ahmadnia
Position
Rasht
Latest degree
Master
Other areas of specialty/work
پرستاری
Street address
Dr. Heshmat Hospital, Bayani St; Mosala Square, Rasht
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 9064
Email
zahmadnia1365@gmail.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