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Comparison of the effect of two different modes of concurrent training on heart performance, biochemical and functional factors associated with sarcopenia in patients with heart failure

Protocol summary

Study aim
Comparison of the effect of two different modes of concurrent training on heart performance, biochemical and functional factors associated with sarcopenia in patients with heart failure
Design
A clinical trial with control group, with parallel groups, randomized, phase 3 on 30 patients. For randomization, restricted randomization with the random allocation rule is used.
Settings and conduct
In order to get familiar with the research implementation process, completion of the consent form and initial assessment, 2 meetings will be held. Then patients participate in 8 weeks of 2 concurrent training methods in Ghalb Al-Zahra Hospital. After 8 weeks of training intervention, 2 more sessions will be held with an interval of 48 hours from the last training session in order to measure the secondary level.
Participants/Inclusion and exclusion criteria
The participants are male and female heart failure patients. The conditions for entering include the age range of 55 to 65 years, ejection fraction equal to and less than 49, and hemodynamic stability for at least 3 months before participating in the research. Also, the conditions of not entering include infection, pulmonary restriction, smoking, significant cardiac arrhythmia, restriction and prohibition of sports activities due to angina or peripheral artery occlusion disease.
Intervention groups
Concurrent training on the same days (resistance training and high intensity interval training on the same day), concurrent training on different days (resistance training and high intensity interval training on different days) and control (they don't do any exercise training).
Main outcome variables
Peak oxygen consumption; 6-minute walking distance test; Appendicular skeletal muscle index; Handgrip strength; Gait speed; Static balance; Left ventricular ejection fraction; Fractional shortening; C-reactive protein; Testosterone; Cortisol

General information

Reason for update
Acronym
نارسایی قلبی یا Heart Failure با اختصار HF
IRCT registration information
IRCT registration number: IRCT20240124060802N1
Registration date: 2024-02-07, 1402/11/18
Registration timing: registered_while_recruiting

Last update: 2024-02-07, 1402/11/18
Update count: 0
Registration date
2024-02-07, 1402/11/18
Registrant information
Name
Zahra Karimi Ahmadabadi
Name of organization / entity
The University of Shiraz
Country
Iran (Islamic Republic of)
Phone
+98 71 3720 6158
Email address
zahrakarimi374@hafez.shirazu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-03, 1402/11/14
Expected recruitment end date
2024-03-17, 1402/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two different modes of concurrent training on heart performance, biochemical and functional factors associated with sarcopenia in patients with heart failure
Public title
Comparison of the effect of two different modes of concurrent training on heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 55 to 65 years Ejection fraction equal to and less than 49 Hemodynamic stability for at least 3 months before participating in the research
Exclusion criteria:
Infection Pulmonary restriction Smoking Significant cardiac arrhythmia Limiting or prohibiting exercise due to angina or peripheral arterial occlusive disease
Age
From 55 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization method with random allocation rule is used. The randomization unit is an individual that is done using a ball in a container. Also, the allocation concealment method is used with sequentially numbered, sealed, opaque envelopes.
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
Research Ethics Committees of Faculty of Psychology and educational Sciences- Shiraz University
Street address
2nd Unit Right Side, 5/12 Alley, Ahmadabad Soghad Town, Allah Sq., Modarres Blvd.
City
Shiraz
Province
Fars
Postal code
7159643447
Approval date
2023-11-08, 1402/08/17
Ethics committee reference number
IR.US.PSYEDU.REC.1402.080

Health conditions studied

1

Description of health condition studied
Heart failure, Sarcopenia
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
Peak oxygen consumption: In this research, peak oxygen consumption is the maximum aerobic power, which is measured by the modified Bruce test and the respiratory gas analysis device.
Timepoint
Measuring peak oxygen consumption before the intervention and 48 hours after the end of the intervention
Method of measurement
Treadmill and respiratory gas analysis device

2

Description
6-minute walking distance: In this research, 6-minute walking distance means the distance traveled in 6 minutes, which is evaluated by the 6-minute walking test.
Timepoint
Measuring the distance of 6 minutes of walking before the intervention and 48 hours after the end of the intervention
Method of measurement
Stopwatch

3

Description
Appendicular skeletal muscle index: In this research, appendicular skeletal muscle index refers to the mass of upper and lower body skeletal muscles in terms of height, which is measured by DEXA.
Timepoint
Measuring the appendicular skeletal muscle index before the intervention and 48 hours after the end of the intervention
Method of measurement
DEXA device

4

Description
Hand grip strength: It means the maximum hand grip strength, which is measured with a hand grip dynamometer.
Timepoint
Measuring the hand grip strength before the intervention and 48 hours after the end of the intervention
Method of measurement
Handgrip device

5

Description
Gait speed: It means the most comfortable walking speed on the 8-meter path, which is measured by recording the time.
Timepoint
Measuring the gait speed before the intervention and 48 hours after the end of the intervention
Method of measurement
Stopwatch

6

Description
Static balance: means the ability or lack of ability to perform the static balance test of one leg for 10 seconds.
Timepoint
Measuring the static balance before the intervention and 48 hours after the end of the intervention
Method of measurement
Stopwatch

7

Description
Left ventricular ejection fraction: In this study, left ventricular ejection fraction is a percentage of the end-diastolic volume that is ejected from the heart in each beat and is measured by echocardiography.
Timepoint
Measurement of left ventricular ejection fraction before the intervention and 48 hours after the end of the intervention
Method of measurement
Echocardiography device

8

Description
Fractional shortening: Fractional shortening refers to the percentage change in the dimensions of the left ventricle during systole, which is measured by echocardiography.
Timepoint
Measurement of fractional shortening before the intervention and 48 hours after the end of the intervention
Method of measurement
Echocardiography device

9

Description
C-reactive protein: It means its serum concentration, which is measured by ELISA method using a special kit.
Timepoint
Measurement of C-reactive protein before the intervention and 48 hours after the end of the intervention
Method of measurement
Special kit for measuring C-reactive protein amount and required blood collection equipment

10

Description
Testosterone: It means its serum concentration which is measured by ELISA method using a special kit.
Timepoint
Testosterone measurement before the intervention and 48 hours after the end of the intervention
Method of measurement
A special kit for measuring the amount of testosterone and the necessary blood collection equipment

11

Description
Cortisol: It means its serum concentration which is measured by ELISA method using a special kit.
Timepoint
Cortisol measurement before the intervention and 48 hours after the end of the intervention
Method of measurement
A special kit for measuring the amount of cortisol and the necessary equipment for blood sampling

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: It is the concurrent training group on the same days, where a combination of resistance training and high intensity interval training are performed on the same day for 8 weeks. The resistance training protocol includes 1 to 2 sets of 10 to 15 repetitions, with a 1-minute rest between sets and a 2-minute rest between movements. Exercises with dumbbells are performed with an intensity of 50 to 65% of 1 repetition maximum, and in exercises with elastic bands, start with low resistance elastic bands (yellow) and if the person can perform the exercise in question with the rate of perceived exertion below 5 on the modified Borg scale, it also goes to colors with more resistance (red, green and blue). High intensity interval training also includes 4 repetitions of 4 minutes of exercise with an intensity of 80-90% of the peak oxygen consumption on the ergometer cycle, which are separated by 3 active rests with an intensity of 50% of the peak oxygen consumption on the cycle ergometer.
Category
Rehabilitation

2

Description
Intervention group: It is the concurrent training group on different days, where resistance training and high intensity interval training are performed on different for 8 weeks. The resistance training protocol includes 1 to 2 sets of 10 to 15 repetitions, with a 1-minute rest between sets and a 2-minute rest between movements. Exercises with dumbbells are performed with an intensity of 50 to 65% of 1 repetition maximum, and in exercises with elastic bands, start with low resistance elastic bands (yellow) and if the person can perform the exercise in question with the rate of perceived exertion below 5 on the modified Borg scale, it also goes to colors with more resistance (red, green and blue). High intensity interval training also includes 4 repetitions of 4 minutes of exercise with an intensity of 80-90% of the peak oxygen consumption on the ergometer cycle, which are separated by 3 active rests with an intensity of 50% of the peak oxygen consumption on the cycle ergometer.
Category
Rehabilitation

3

Description
Control group: The control group is that in this group, patients do not do any type of exercise for 8 weeks.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghalb Al-Zahra hospital
Full name of responsible person
حجت الله روستا
Street address
Ghalb Al-Zahra Hospital, Astane Junction, Siboyeh Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۶۴۹۵۴۹۳۷
Phone
+98 71 3739 8813
Email
paymanizadpanah@gmail.com
Web page address
https://hfhc.sums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghalb Al-Zahra hospital
Full name of responsible person
Hojjatollah Roosta
Street address
Ghalb Al-Zahra Hospital, Astane Junction, Sibooyeh Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
5493771649
Phone
+98 71 3739 7813
Email
paymanizadpanah@gmail.com
Web page address
https://hfhc.sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghalb Al-Zahra hospital
Proportion provided by this source
80
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
Other

2

Sponsor
Name of organization / entity
The University of Shiraz
Full name of responsible person
Mohammad Moazeni
Street address
Shiraz University, Eram Sq., Jomhoori Eslami Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7194684334
Phone
+98 71 3613 4000
Email
pr@shirazu.ac.ir
Web page address
https://shirazu.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 Shiraz
Proportion provided by this source
20
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
The University of Shiraz
Full name of responsible person
Zahra Karimi Ahmadabadi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
2nd Unit Right Side, 5/12 Alley, Ahmadabad Soghad Town, Allah Sq., Modarres Blvd.
City
Shiraz
Province
Fars
Postal code
7159643447
Phone
+98 71 3720 6158
Fax
Email
zahrakarimi374@hafez.shirazu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Shiraz
Full name of responsible person
Zahra Karimi Ahmadabadi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
2nd Unit Right Side, 5/12 Alley, Ahmadabad Soghad Town, Allah Sq., Modarres Blvd.
City
Shiraz
Province
Fars
Postal code
7159643447
Phone
+98 71 3720 6158
Fax
Email
zahrakarimi374@hafez.shirazu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Shiraz
Full name of responsible person
Zahra Karimi Ahmadabadi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
2nd Unit Right Side, 5/12 Alley, Ahmadabad Soghad Town, Allah Sq., Modarres Blvd.
City
Shiraz
Province
Fars
Postal code
7159643447
Phone
+98 71 3720 6158
Fax
Email
zahrakarimi374@hafez.shirazu.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All subjects' data (non-identifiable), study protocol, statistical analysis map, informed consent form and clinical study report will be published.
When the data will become available and for how long
Access starts 6 months after results and article are published
To whom data/document is available
Researchers working in academic, scientific and medical institutions
Under which criteria data/document could be used
In order to be used for future research
From where data/document is obtainable
1. Zahra Karimi Ahmadabadi by email: setarekarimi374@gmail.com Faculty of Educational Sciences and Psychology, Shiraz University 2. Dr. Javad Nemati by email: nemati_phy@yahoo.com Faculty of Educational Sciences and Psychology, Shiraz University
What processes are involved for a request to access data/document
Correspondence by email
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