Determining the effect of two protocols of high-intensity intermittent training (HIIT) and moderate-intensity continuous training (MICT) on aerobic performance, anthropometric indices and ejection fraction in patients with chronic heart failure
Determining the effect of two protocols of high-intensity intermittent training (HIIT) and moderate-intensity continuous training (MICT) on aerobic performance, anthropometric indices and ejection fraction in patients with chronic heart failure
Design
Clinical trial without control group, with parallel groups, without blinding, on 70 patients, randomization by computer numbers.
Settings and conduct
Eligible patients referring to the rehabilitation clinic of Fatemeh Zahra Sari Hospital are assigned to one group of HIIT exercises and another group with MICT exercises.
The exercise program will be under cardiac monitoring 3 times a week for 4 weeks. The MICT session will consist of aerobic exercise starting at 40–50% and progressing to 70–80% HRR. Each HIIT session consists of work intervals of 30 sec to 4 min with a maximum intensity of 85%-90% HRR separated by 1-3 min rest intervals with an intensity of 50-70%.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) age 30 to 70 years 2) sinus rhythm 3) agreement and compliance with our study protocol 4) possibility to sign the informed consent form
Exclusion criteria: 1) people with peripheral vascular disease, 2) ventricular premature beats or other arrhythmias 3) cardiac conduction defects 4) history of pacemaker placement 5) significant valvular heart disease 6) arterial blood pressure greater than 180/100 mm mercury, 7) functional limitations (such as physical limitations) and 8) concurrent participation in another clinical trial.
Intervention groups
Our study will be conducted on patients with chronic heart failure referred to the Cardiovascular Rehabilitation Center of Fatemeh Zahra Sari Heart Hospital.
Main outcome variables
Primary outcomes includes ejection fraction and 6-minute walk test and secondary outcomes includes LV size، RV size، LV Global Strain، RV Function and anthropometric indices.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240126060809N1
Registration date:2024-01-30, 1402/11/10
Registration timing:prospective
Last update:2024-01-30, 1402/11/10
Update count:0
Registration date
2024-01-30, 1402/11/10
Registrant information
Name
Najmeh Ghorbanian Bahnamiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 6552
Email address
njm.ghorbanian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-31, 1402/11/11
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of two protocols of high-intensity intermittent training (HIIT) and moderate-intensity continuous training (MICT) on aerobic performance, anthropometric indices and ejection fraction in patients with chronic heart failure
Public title
Determining the effect of two protocols of high-intensity intermittent training (HIIT) and moderate-intensity continuous training (MICT) on aerobic performance, anthropometric indices and ejection fraction in patients with chronic heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30 to 70 years
sinus rhythm
Agreeing and complying with our study protocol
The possibility of signing an informed consent form
Exclusion criteria:
People with peripheral vascular disease
Ventricular premature beats or other arrhythmias
Cardiac conduction defects
History of cardiac pacemaker insertion
Significant valvular heart disease
Arterial blood pressure greater than 180/100 mm Hg
Functional limitations (such as physical limitations)
Concurrent participation in another clinical trial
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using computer generated random numbers from 1 to 70. Numbers will be placed in envelopes in the package. Participants with even numbers will be assigned to the HIIT exercise protocol group and odd numbers to the MICT exercise protocol group.
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 Mazandaran University of Medical Sciences, Fateme Zahra Hospital
Street address
Serah Joibar, the beginning of Vali Asr Highway, the headquarters of Mazandaran University of Medical Sciences and Health Services
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Approval date
2024-01-14, 1402/10/24
Ethics committee reference number
IR.MAZUMS.REC.1402.585
Health conditions studied
1
Description of health condition studied
Chronic Heart Failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Ejection fraction
Timepoint
Before the intervention and at the end of 12 cardiac rehabilitation sessions
Method of measurement
Echocardiography device
2
Description
Aerobic performance
Timepoint
Before the intervention and at the end of 12 cardiac rehabilitation sessions
Method of measurement
6-min Walking Test
Secondary outcomes
1
Description
Left ventricular size
Timepoint
Before starting cardiac rehabilitation and at the end of 12 rehabilitation sessions
Method of measurement
Echocardiography device
2
Description
left atrium size
Timepoint
Before starting cardiac rehabilitation and at the end of 12 rehabilitation sessions
Method of measurement
Echocardiography device
3
Description
Left ventricular global strain
Timepoint
Before starting cardiac rehabilitation and at the end of 12 rehabilitation sessions
Method of measurement
Echocardiography device
4
Description
Right ventricular function
Timepoint
Before starting cardiac rehabilitation and at the end of 12 rehabilitation sessions
Method of measurement
Echocardiography device
5
Description
Body mass index
Timepoint
Before starting cardiac rehabilitation and at the end of 12 rehabilitation sessions
Method of measurement
Body analyze device
6
Description
Skeletal muscle mass
Timepoint
Before starting cardiac rehabilitation and at the end of 12 rehabilitation sessions
Method of measurement
Body analyze device
7
Description
Body fat mass
Timepoint
Before starting cardiac rehabilitation and at the end of 12 rehabilitation sessions
Method of measurement
Body analyze device
Intervention groups
1
Description
Intervention group: the first group of MICT exercise rehabilitation includes 20-60 minutes of progressive aerobic exercise including; Treadmill running, free running, manual ergometer, and stationary bike will receive VO2 reserve (HRR (Heart rate reserve)) starting at 40%–50% and progressing to 70%–80%.If HRmax is unknown, RPE (Rate of Perceived Exertion) is used to guide exercise intensity. Light, RPE less than 12 or equivalent to 40% HRR. A little hard with RPE 12-13 or average with 40-59% HRR. Hard with RPE 14-16 or equivalent to 60-80% HRR.
Category
Rehabilitation
2
Description
Intervention group: The second group receives a HIIT rehabilitation session including work intervals of 30 seconds to 4 minutes with a maximum intensity of 85%-90% HRR with rest intervals of 1-3 minutes with an intensity of 50-70%. If HRmax is unknown, RPE (Rate of Perceived Exertion) is used to guide exercise intensity. Light, RPE less than 12 or equivalent to 40% HRR. A little hard with RPE 12-13 or average with 40-59% HRR. Hard with RPE 14-16 or equivalent to 60-80% HRR.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatima Zahra Hospital, Sari
Full name of responsible person
Najmeh Ghorbanian Bahnamiri
Street address
Cardiopulmonary Rehabilitation Center, Fatemeh Zahra Hospital, Army Boulevard, Imam Hossein Square
City
Sari
Province
Mazandaran
Postal code
4818813371
Phone
+98 11 3332 3023
Email
njm.ghorbanian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Moalem Square,Sari City,Mazandaran Province, Research and Technology Deputy Building
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3354 3081
Email
pebrahimnejad@mazums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?