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IRCT20240124060802N1 IRCT 2024-02-07 Ghalb Al-Zahra hospital Comparison of the effect of two different modes of concurrent training on heart failure نارسایی قلبی یا Heart Failure با اختصار HF 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 2024-02-03 anticipated 30 Complete https://irct.ir/trial/75177 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. N/A Heart failure, Sarcopenia. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control group: The control group is that in this group, patients do not do any type of exercise for 8 weeks. Yes - There is a plan to make this available What will be shared: All subjects' data (non-identifiable), study protocol, statistical analysis map, informed consent form and clinical study report will be published. When: Access starts 6 months after results and article are published To whom: Researchers working in academic, scientific and medical institutions Conditions: In order to be used for future research Where to obtain: 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 How to obtain: Correspondence by email Comments:
public Zahra Karimi Ahmadabadi
2nd Unit Right Side, 5/12 Alley, Ahmadabad Soghad Town, Allah Sq., Modarres Blvd.
Shiraz Iran (Islamic Republic of) 7159643447 +98 71 3720 6158 zahrakarimi374@hafez.shirazu.ac.ir The University of Shiraz scientific Zahra Karimi Ahmadabadi
2nd Unit Right Side, 5/12 Alley, Ahmadabad Soghad Town, Allah Sq., Modarres Blvd.
Shiraz Iran (Islamic Republic of) 7159643447 +98 71 3720 6158 zahrakarimi374@hafez.shirazu.ac.ir The University of Shiraz Iran (Islamic Republic of) 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 55 years 65 years Both Infection Pulmonary restriction Smoking Significant cardiac arrhythmia Limiting or prohibiting exercise due to angina or peripheral arterial occlusive disease I50 Heart failure Rehabilitation Rehabilitation Other 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. 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. Control group: The control group is that in this group, patients do not do any type of exercise for 8 weeks. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. The University of Shiraz Ghalb Al-Zahra hospital The University of Shiraz Approved 2023-11-08 Research Ethics Committees of Faculty of Psychology and educational Sciences- Shiraz University 2nd Unit Right Side, 5/12 Alley, Ahmadabad Soghad Town, Allah Sq., Modarres Blvd. Shiraz Fars Iran (Islamic Republic of)