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IRCT20230515058202N1 IRCT 2024-01-24 Bandare-abbas University of Medical Sciences Evaluating the effects of exercises in patients with thalassemia major Evaluating the effects of cardiac rehabilitation exercises (aerobic and endurance exercises) on cardiac function, functional capacity, quality of life and mental health of patients with thalassemia major 2023-10-23 anticipated 50 Complete https://irct.ir/trial/72896 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: People are randomly divided into two groups. The first group receives rehabilitation intervention and the second group does not receive any intervention, Randomization description: In this study, randomization will be done in the form of simple random allocation to equalize the sample size in the groups. Randomization will be done through tables of random or random numbers and by computers that set the numbers randomly. The table of random numbers that will be used was produced by the Institute of RAND (www.rand.org). These tables have random numbers in both rows and columns. First, the names of all patients are numbered. Then, in order to select the people of the intervention group from the table of random numbers, the researcher randomly chooses a number from the table and then moves in the direction of the row or column and chooses the next numbers in order until the last person of the intervention group is identified. Then the unselected people They are in the control group, Blinding description: In this research, blinding was done using a single-blind method, and the patients were randomly assigned to two intervention and control groups, and the clinical caregiver recorded the relevant information after the rehabilitation. The group provides this information to the analyst. The analyzer remains unaware of which group the information belongs to. N/A Thalassemia major disease. Intervention 1: Intervention group: People in the intervention group do 8 weeks of planned rehabilitation exercises.The exercise program includes aerobic and resistance exercises. The aerobic exercise program consists of 1 hour of aerobic exercise, which consists of 10 minutes of warm-up (stretching of the upper and lower limbs), 20 to 30 minutes of exercise with a treadmill or cycle ergometer with an intensity of 70%. The maximum HR obtained from the exercise test is the cool-down (dynamic exercises with low intensity and stretching of the upper and lower limbs) and the resting phase (for 10 minutes). Aerobic exercise program is done twice a week for 8 weeks. In addition, in parallel and simultaneously, a resistance training protocol (twice a week, for 8 weeks, and on the days when the aerobic exercise program is not carried out) is implemented. Each session lasts for 1 hour and consists of warm-up periods, high-repetition/low-load resistance training program (HR/LL-RT) on the leg press and cool-down. The warm-up and cool-down sections also include body stretching. It is lower. Test subjects perform 3 sets in 2 minutes with a movement rhythm of 10 repetitions per minute and maintain the breathing rate. Each repetition takes 5 seconds (2 seconds of opening and 3 seconds of knee and hip flexion). ) with a rhythm controlled by verbal commands. The sets are separated by 5-minute rest intervals. The exercise intensity is 30% of 1 RM. These patients are also under routine medical care and follow-up (i.e., regular visits by Cardiologist) are placed. Intervention 2: Control group: These patients are followed up every 2 weeks for 8 weeks by phone call. This call is to provide more information about adherence to the study protocol and to remind and encourage patients to continue with future visits and to ascertain whether there are any new changes in medical events. And whether or not there has been a drug since the previous contact, it takes place. 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 There is no further information
public zahra saadat
Bandar Abbas, the beginning of Imam Hossein Blvd., University of Medical Sciences campus educational complex
bandar abbas Iran (Islamic Republic of) 791661388 076-33333280-9 saadatzahra@gmail.com Bandare-abbas University of Medical Sciences scientific saadat zahra
Bandar Abbas, the beginning of Imam Hossein Blvd., University of Medical Sciences campus educational complex
Bandar Abbas Iran (Islamic Republic of) 791661388 076-33333280-9 saadatzahra@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Thalassemia major patients who undergo regular blood transfusions and receive packed cells every month. Patients receiving iron chelator with regular blood transfusion such as desferal or deferiprone at the same time. Left ventricular ejection fraction equal to or more than 50% New York Heart Association (NYHA) functional class I, II, or III. Being in the age range of 18 to 40 years Having the desire and motivation to participate in the training program 18 years 40 years Both Severe exercise intolerance uncontrolled arrhythmia, uncontrolled angina pectoris, severe kidney or lung disease, musculoskeletal or neuromuscular conditions that preclude exercise or exercise testing, and signs or symptoms of ischemia and abnormal hemodynamic responses during previous incremental exercise test, suffering from severe mental and psychiatric diseases, use of psychoactive drugs, uncontrolled blood pressure and diabetes, clinical evidence of other secondary causes of pulmonary hypertension including HIV infection, hepatitis virus infection, Collagen vascular diseases, cirrhosis, chronic obstructive airway diseases and acquired heart disease associated with pulmonary hypertension. D56.1 Beta thalassaemia Rehabilitation Rehabilitation Intervention group: People in the intervention group do 8 weeks of planned rehabilitation exercises.The exercise program includes aerobic and resistance exercises. The aerobic exercise program consists of 1 hour of aerobic exercise, which consists of 10 minutes of warm-up (stretching of the upper and lower limbs), 20 to 30 minutes of exercise with a treadmill or cycle ergometer with an intensity of 70%. The maximum HR obtained from the exercise test is the cool-down (dynamic exercises with low intensity and stretching of the upper and lower limbs) and the resting phase (for 10 minutes). Aerobic exercise program is done twice a week for 8 weeks. In addition, in parallel and simultaneously, a resistance training protocol (twice a week, for 8 weeks, and on the days when the aerobic exercise program is not carried out) is implemented. Each session lasts for 1 hour and consists of warm-up periods, high-repetition/low-load resistance training program (HR/LL-RT) on the leg press and cool-down. The warm-up and cool-down sections also include body stretching. It is lower. Test subjects perform 3 sets in 2 minutes with a movement rhythm of 10 repetitions per minute and maintain the breathing rate. Each repetition takes 5 seconds (2 seconds of opening and 3 seconds of knee and hip flexion). ) with a rhythm controlled by verbal commands. The sets are separated by 5-minute rest intervals. The exercise intensity is 30% of 1 RM. These patients are also under routine medical care and follow-up (i.e., regular visits by Cardiologist) are placed. Control group: These patients are followed up every 2 weeks for 8 weeks by phone call. This call is to provide more information about adherence to the study protocol and to remind and encourage patients to continue with future visits and to ascertain whether there are any new changes in medical events. And whether or not there has been a drug since the previous contact, it takes place. Ferritin. Timepoint: Before the intervention and after the intervention. Method of measurement: Serum ferritin level by chemiluminescence method with Abbott Architect i1000SR Immunoassay System. Quality of Life. Timepoint: Before the intervention and after the intervention. Method of measurement: SF-36 questionnaire. Mental health. Timepoint: Before the intervention and after the intervention. Method of measurement: SCL-90-R questionnaire. HR Recovery. Timepoint: Before the intervention and after the intervention. Method of measurement: exercise test. Exercise capacity. Timepoint: Before the intervention and after the intervention. Method of measurement: 6-minute walk test. Cardiac function. Timepoint: Before the intervention and after the intervention. Method of measurement: Echocardiography. Bandare-abbas University of Medical Sciences Approved 2023-08-23 Ethics committee of Hormozgan University of Medical Sciences Bandar Abbas, the beginning of Imam Hossein Blvd., University of Medical bandar abbas Hormozgan Iran (Islamic Republic of)