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IRCT20180128038541N1 IRCT 2018-02-13 Iran University of Medical Sciences Effects of exercises on inflammatory markers, anti-inflammatory markers, cross sectional area , muscle architecture, kinematic and kinetic parameters in moderate hemophilia A patients Effects of six weeks aerobic, resistance, and combined exercises on inflammatory markers, anti-inflammatory markers, cross sectional area , muscle architecture, kinematic and kinetic parameters in overweight moderate hemophilia A patients 2017-10-21 anticipated 50 Complete https://irct.ir/trial/29356 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The probability sampling method is simple randomization.Randomization was performed by an external observer using closed envelopes in blocks of 8, each assigned to two subjects, Blinding description: The person collecting , determining the blood samples, sonography and MRI measurements, kinematic parameters, kinetic parameters and data analyser and Data Saftey and Monitoring Committee are blinded to the grouping, but the physiotherapist for training( researcher) and participants is not masked to the group assignment. 3 Moderate Hemophilia A. Intervention 1: Intervention group 1: Resistanve exercise: Resistance training group require to perform six weeks trunk, upper and lower limb exercises (65-75% 1RM) , 40 min per session , three days per week.Strength-training exercises consist of knee flexion, knee extension, shoulder press, chest press, leg press, calf raise, and squat. Subjects perform 10 repetitions of each exercise during the first, third and fifth weeks and 12 repetitions of each exercise during the second, fourth and sixth weeks of training. Intervention 2: Intervention group 2: Aerobic exercise: Aerobic exercise perform on treadmill and cycle ergometer . Aerobic exercise intensity is adjusted based on maximum heart rate (220 - age = MHR). In the first, second, and third of each two-week period, the target intensity is 65%, 70%, and 75% of MHR,respectively. Each exercise session consist of aerobic training on a treadmill for 22 minutes ,and cycle ergometer for 22 minutes. Each step include warm up, training at constant workload, and cool down. A 3-minute warm-up phase followed by 12 minutes training at constant workload phase and a 2-minute cool down phase is used for the aerobic exercises. Intervention 3: Intervention group3: Combined exercise:In the combined resistance with aerobic training group, the intensity of the resistance exercises is similar to that for the resistance training group, but there is five repetitions of each exercise in the first, third, and fifth weeks and six repetitions during the second, fourth, and sixth weeks of training. After 22 minutes of aerobic exercises, patients perform 20 minutes resistance exercises. Each exercise session consisted of aerobic training on a treadmill for 11 minutes ,and cycle ergometer for 11 minutes. Each step include warm up, training at constant workload, and cool down. A 3-minute warm-up phase followe by 6 minutes training at constant workload phase and a 2-minute cool down phase is used for the aerobic exercises. Intervention 4: Control group: The control group is requested not to change their daily physical activity during the 6 weeks. Yes - There is a plan to make this available What will be shared: Information about serum markers, MSK sonography and MRI, kinematic and kinetic parameters When: Starting 6 months after publication To whom: Physiotherapist and orthopadist related with hemophilia patients Conditions: Coopration for article publishing using our data for investigation of effect of exercise with more duration on the muscle cross section area and architecture, kinematic and kinetic parameters Where to obtain: Behrouz Parhampour, first email and then call phone: 02144925035 behrouz.parhampour@gmail.com How to obtain: Sending email and answering within 2 next weeks Comments:
public Behnoosh Vasaghi Gharamaleki
Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS
Tehran Iran (Islamic Republic of) 1545913187 +98 21 2222 8051 bvasaghi@gmail.com Iran University of Medical Sciences scientific Behnoosh Vasagh Gharamaleki
Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS
Tehran Iran (Islamic Republic of) 1545913187 +98 21 2222 8051 bvasaghi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Men with moderate haemophilia A (factor VIII 1% -5 %) Aged 35–55 years; Body mass index 25–30 kg/m2; No history of an inhibitor; Total Hemophilia Joint Health Score (HJHS) ≤10 Factor VIII prophylaxis before and during treatment protocol 35 years 55 years Male Clinical signs of active bleeding Participation in regular physical training activities (more than two times per week) in the previous six months High blood pressure at rest (systolic >160 mmHg, diastolic >10 mmHg) D66 Hereditary factor VIII deficiency Rehabilitation Rehabilitation Rehabilitation Rehabilitation Intervention group 1: Resistanve exercise: Resistance training group require to perform six weeks trunk, upper and lower limb exercises (65-75% 1RM) , 40 min per session , three days per week.Strength-training exercises consist of knee flexion, knee extension, shoulder press, chest press, leg press, calf raise, and squat. Subjects perform 10 repetitions of each exercise during the first, third and fifth weeks and 12 repetitions of each exercise during the second, fourth and sixth weeks of training. Intervention group 2: Aerobic exercise: Aerobic exercise perform on treadmill and cycle ergometer . Aerobic exercise intensity is adjusted based on maximum heart rate (220 - age = MHR). In the first, second, and third of each two-week period, the target intensity is 65%, 70%, and 75% of MHR,respectively. Each exercise session consist of aerobic training on a treadmill for 22 minutes ,and cycle ergometer for 22 minutes. Each step include warm up, training at constant workload, and cool down. A 3-minute warm-up phase followed by 12 minutes training at constant workload phase and a 2-minute cool down phase is used for the aerobic exercises. Intervention group3: Combined exercise:In the combined resistance with aerobic training group, the intensity of the resistance exercises is similar to that for the resistance training group, but there is five repetitions of each exercise in the first, third, and fifth weeks and six repetitions during the second, fourth, and sixth weeks of training. After 22 minutes of aerobic exercises, patients perform 20 minutes resistance exercises. Each exercise session consisted of aerobic training on a treadmill for 11 minutes ,and cycle ergometer for 11 minutes. Each step include warm up, training at constant workload, and cool down. A 3-minute warm-up phase followe by 6 minutes training at constant workload phase and a 2-minute cool down phase is used for the aerobic exercises. Control group: The control group is requested not to change their daily physical activity during the 6 weeks. IL-6: Inflammatory marker. Timepoint: Before and after six weeks exercise. Method of measurement: ELISA kit, Invitrogen, San Diego,USA. TNF: Inflammatory marker. Timepoint: Before and after six weeks exercise. Method of measurement: ELISA kit, Invitrogen, San Diego,USA. Hs-CRP:Inflammatory marker. Timepoint: Before and after six weeks exercise. Method of measurement: ELISA kit, Invitrogen, San Diego,USA. IL-10: Anti inflammatiry marker. Timepoint: Before and after six weeks exercise. Method of measurement: ELISA kit, Invitrogen, San Diego,USA. Adiponectine: Anti inflammatiry marker. Timepoint: Before and after six weeks exercise. Method of measurement: ELISA kit, Invitrogen, San Diego,USA. Muscle Thickness and pennation angle. Timepoint: Before and after six weeks exercise. Method of measurement: Ultrasonography, B mode. Muscle cross sectional area. Timepoint: Before and after six weeks exercise. Method of measurement: Axial plane scans using MRI scanner. Angular displacement and velocity of the knee and hip joints in three planes including sagital, frontal and transverse planes. Timepoint: Before and after six weeks exercise. Method of measurement: Marking the knee and hip joints and recording by the camera of the motion analysis (Vicon). Mean, standard deviation, total displacement and velocity of center of pressure during walking and sit to stand in the frontal and sagital planes. Timepoint: Before and after six weeks exercise. Method of measurement: Force plate (Kistler) With a sampling rate of 100 Hz. Iran University of Medical Sciences Approved 2016-06-28 Ethics committee of Iran University of Medical Sciences Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS Tehran Tehran Iran (Islamic Republic of)