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IRCT20210104049939N1 IRCT 2023-06-01 Najaf Abadَ Islamic Azad University Comparison of the effect of 12 weeks of aerobic and combined training based on performance indicators and some other cardiovascular risk factors affected by amputation ectc The Comparison of Eeffect of Aerobic and Combined Exercise Training on Functional Indicators and some cardiovascular risk factors in lower-limb amputee 2023-03-21 anticipated 45 Complete https://irct.ir/trial/53494 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Randomization description: After the announcement of the call and examination of the medical files, the candidates are enrolled in the study, and after the examination, based on the criteria of entry and exit from the study, 45 veterans of lower body amputations are selected as a sample. 45 samples are selected through available sampling and randomly divided into one of 3 groups: aerobic training (15 people), combined training (15 people) and control (15 people). Randomization is done by block method and by an assistant outside the research. In this way, the samples are randomized in the form of 3:3:3 blocks in each of the studied groups, Blinding description: The subjects are blinded to the grouping and the training sessions of the groups are done on different days. N/A Lower limb amputation veterans. Intervention 1: Intervention group: Aerobic exercise: Aerobic group exercises include 12 weeks of exercises, 3 sessions per week and each session is between 30 and 50 minutes and with increasing load. Each training session consists of three parts: warm-up, main training body and cool-down. Exercises start in the first week with an intensity of 40% of the maximum heart rate and finally reach 70% of the maximum heart rate in the twelfth week. Maximum heart rate measurement is evaluated using the formula (220-Sen). Also, the assessment of the heart rate of exercise using a polar hourly heart rate monitor. Intervention 2: Intervention group: Combined exercise: Combined group exercises include aerobic and resistance exercises that are performed for 12 weeks, 3 sessions per week and each session between 30 and 60 minutes, with extra load. Each training session consists of three parts: warm-up, main training body and cool-down. The aerobic part of the exercises is performed in the same way as the aerobic exercise group, but with half the time of the aerobic exercise group. The resistance exercises section includes resistance exercises for the upper body with equipment and free weights for the main and large muscle groups of the upper body (head, forearm, chest, armpit, back of the arm, abdomen). Resistance exercises in the first week in 2 sets with 8-12 repetitions. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I am completing the information in the future for sure
public Maliheh Heydari
Isfahan, Najaf Abad, University Boulevard, Najaf Abad Azad University
Najaf Abad Iran (Islamic Republic of) 8514143131۸۵۱ +98 31 4229 2929 info @ iaun.ac.ir Najafabad Azad University scientific Maliheh Heydari
Najafabad branch, Islamic Azad University, Daneshgah Boulevard
Najaf Abad Iran (Islamic Republic of) 8514143131 +98 31 4229 2929 ict@iaun.ac.ir Islamic Azad University, Najaf Abad branch Iran (Islamic Republic of) Lower extremity amputation veteran Written consent to enter the research Do not have a history of regular sports activities Have no history of advanced metabolic disease Do not smoke Age 45 to 60 years old Being male 45 years 60 years Male Veterans of upper limb amputation and spinal cord amputation Having a regular sports record Having advanced metabolic disease smoking Infectious diseases such as influenza and covid Failure to participate in training Prevention Prevention Intervention group: Aerobic exercise: Aerobic group exercises include 12 weeks of exercises, 3 sessions per week and each session is between 30 and 50 minutes and with increasing load. Each training session consists of three parts: warm-up, main training body and cool-down. Exercises start in the first week with an intensity of 40% of the maximum heart rate and finally reach 70% of the maximum heart rate in the twelfth week. Maximum heart rate measurement is evaluated using the formula (220-Sen). Also, the assessment of the heart rate of exercise using a polar hourly heart rate monitor. Intervention group: Combined exercise: Combined group exercises include aerobic and resistance exercises that are performed for 12 weeks, 3 sessions per week and each session between 30 and 60 minutes, with extra load. Each training session consists of three parts: warm-up, main training body and cool-down. The aerobic part of the exercises is performed in the same way as the aerobic exercise group, but with half the time of the aerobic exercise group. The resistance exercises section includes resistance exercises for the upper body with equipment and free weights for the main and large muscle groups of the upper body (head, forearm, chest, armpit, back of the arm, abdomen). Resistance exercises in the first week in 2 sets with 8-12 repetitions Improvement of C-reactive protein level in the blood of lower limb amputees due to exercise.due to exercise. Timepoint: 24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects. Method of measurement: Blood tests. Improving the level of interleukin-6 in the blood of lower limb amputees due to aerobic and combined exercise. Timepoint: 24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects. Method of measurement: Blood tests. Improving the level of v-cam in the blood of lower limb amputees due to aerobic and combined exercise. Timepoint: 24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects. Method of measurement: Blood tests. Improving blood ESR levels of lower limb amputees due to aerobic and combined exercise. Timepoint: 24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects. Method of measurement: Blood tests. Improving the fasting blood sugar level of lower limb amputees due to aerobic and combined exercise. Timepoint: 24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects. Method of measurement: Blood tests. Improvement of systolic blood pressure of lower limb amputees due to aerobic and combined exercise. Timepoint: 24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training, the individual's resting blood pressure is taken. Method of measurement: Manometer. Improvement of diastolic blood pressure of lower limb amputees due to aerobic and combined exercise. Timepoint: 24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training, the individual's resting blood pressure is taken. Method of measurement: Manometer. Improving the red blood cell sedimentation rate of lower limb amputees due to aerobic and combined exercise. Timepoint: 24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects. Method of measurement: Blood test. Lowering blood cholesterol levels of lower limb amputees due to aerobic and combined exercise. Timepoint: 24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects. Method of measurement: Blood test. Reducing the level of low-density lipoprotein cholesterol in the blood of lower limb amputees due to aerobic and combined exercise. Timepoint: 24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects. Method of measurement: Blood test. Increasing the level of high-density lipoprotein cholesterol in the blood of lower limb amputees due to aerobic and combined exercise. Timepoint: 24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects. Method of measurement: Blood test. Reducing blood triglyceride levels of lower limb amputees due to aerobic and combined exercise. Timepoint: 24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects. Method of measurement: Blood test. Improvement of blood alanine aminotransferase levels of lower limb amputees due to aerobic and combined exercise. Timepoint: 24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects. Method of measurement: Blood test. Reduction of aspartate aminotransferase levels in the blood of lower limb amputees due to aerobic and combined exercise. Timepoint: 24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects. Method of measurement: Blood test. Improvement of the end-systolic and diastolic inner diameter of the heart due to aerobic and combined exercise. Timepoint: 24 hours before the start of the first exercise and 24 hours after the last exercise, each subject was asked to lie on his left side after choosing the most suitable image of the heart chambers in the resting state, the end-diastolic and systolic diameters (mm) were measured by one-dimensional method. will be. Method of measurement: Echocardiography device. Improvement of left ventricular ejection fraction due to aerobic and combined exercise. Timepoint: 24 hours before the start of the first exercise and 24 hours after the last exercise, each subject was asked to lie on his left side. After selecting the most appropriate image of the heart chambers in the resting state, the variables of the ejection fraction (percentage) are measured by the one-dimensional method. Method of measurement: Echocardiography device. Improving the thickness of the interventricular wall of the heart due to aerobic and combined exercise. Timepoint: 24 hours before the start of the first exercise and 24 hours after the last exercise, each subject was asked to lie on his left side after choosing the most appropriate image of the heart chambers in the resting state, varying the thickness of the interventricular septum (mm) with a one-dimensional measurement method. Method of measurement: Echocardiography device. Improving the thickness of the posterior wall of the left ventricle of the heart as a result of aerobic and combined exercise. Timepoint: 24 hours before the start of the first exercise and 24 hours after the last exercise, each subject was asked to lie on his left side after selecting the most suitable image of the heart chambers in the resting state, varying the thickness of the posterior wall of the left ventricle (mm) with a one-dimensional method. will be measured. Method of measurement: Echocardiography device. Najaf Abadَ Islamic Azad University Approved 2020-09-09 Ethics Committee of Islamic Azad University, Najaf Abad branch Arghavan Street Najafabad Isfehan Iran (Islamic Republic of)