Protocol summary
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Study aim
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Effects of six weeks aerobic, resistance, and combined exercises on inflammatory markers, anti-inflammatory markers, cross sectional area and muscle architecture, kinematic and kinetic parameters in overweight patients moderate hemophilia A
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Design
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A randomized, controlled, Blood sample, sonography, MRI, kinematic and kinetic assessor-blinded, six-week trial, three times weekly
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Settings and conduct
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The exercise training and parameters measurement are done in the Department of Physiotherapy,School of Rehabilitation Sciences, IUMS. Muscle thickness and pennation angle is measured using the B-mode ultrasound , cross sectional area using MRI (Axial planes) at 50% of the arm and thigh length. Kinematic parameters using motion analysis (vicon) and kinetic parameters using force plate (kistler) system are measured.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: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
Exclusion criteria: 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)
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Intervention groups
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Resistance Exercise Group
Aerobic Exercise Group
Combined Exercise Group
Control Group
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Main outcome variables
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IL-6, IL-10, TNF. hs-CRP, Adiponectine, muscle thickness, pennation angle, cross section area of biceps, triceps,vastus medialis and vastus lateralis, angular displacement and velocity of joints, mean and standard deviation, velocity and total displacement of center of pressure
General information
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Reason for update
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Add previously Measured variables with the same proposal, material, methods and study population
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180128038541N1
Registration date:
2018-02-13, 1396/11/24
Registration timing:
retrospective
Last update:
2020-04-23, 1399/02/04
Update count:
1
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Registration date
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2018-02-13, 1396/11/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-10-21, 1396/07/29
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Expected recruitment end date
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2018-01-19, 1396/10/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effects of exercises on inflammatory markers, anti-inflammatory markers, cross sectional area , muscle architecture, kinematic and kinetic parameters in moderate hemophilia A patients
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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)
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Age
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From 35 years old to 55 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-06-28, 1395/04/08
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Ethics committee reference number
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IR.IUMS.REC.1395.9211342206
Health conditions studied
1
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Description of health condition studied
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Moderate Hemophilia A
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ICD-10 code
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D66
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ICD-10 code description
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Hereditary factor VIII deficiency
Primary outcomes
1
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Description
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IL-6: Inflammatory marker
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Timepoint
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Before and after six weeks exercise
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Method of measurement
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ELISA kit, Invitrogen, San Diego,USA
2
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Description
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TNF: Inflammatory marker
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Timepoint
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Before and after six weeks exercise
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Method of measurement
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ELISA kit, Invitrogen, San Diego,USA
3
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Description
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hs-CRP:Inflammatory marker
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Timepoint
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Before and after six weeks exercise
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Method of measurement
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ELISA kit, Invitrogen, San Diego,USA
4
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Description
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IL-10: Anti inflammatiry marker
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Timepoint
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Before and after six weeks exercise
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Method of measurement
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ELISA kit, Invitrogen, San Diego,USA
5
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Description
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Adiponectine: Anti inflammatiry marker
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Timepoint
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Before and after six weeks exercise
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Method of measurement
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ELISA kit, Invitrogen, San Diego,USA
6
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Description
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Muscle Thickness and pennation angle
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Timepoint
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Before and after six weeks exercise
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Method of measurement
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Ultrasonography, B mode
7
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Description
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Muscle cross sectional area
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Timepoint
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Before and after six weeks exercise
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Method of measurement
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Axial plane scans using MRI scanner
8
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Description
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Angular displacement and velocity of the knee and hip joints in three planes including sagital, frontal and transverse planes
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Timepoint
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Before and after six weeks exercise
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Method of measurement
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Marking the knee and hip joints and recording by the camera of the motion analysis (Vicon)
9
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Description
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Mean, standard deviation, total displacement and velocity of center of pressure during walking and sit to stand in the frontal and sagital planes
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Timepoint
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Before and after six weeks exercise
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Method of measurement
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Force plate (Kistler) With a sampling rate of 100 Hz
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
3
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Description
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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.
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Category
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Rehabilitation
4
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Description
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Control group: The control group is requested not to change their daily physical activity during the 6 weeks.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information about serum markers, MSK sonography and MRI, kinematic and kinetic parameters
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When the data will become available and for how long
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Starting 6 months after publication
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To whom data/document is available
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Physiotherapist and orthopadist related with hemophilia patients
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Under which criteria data/document could be used
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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
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From where data/document is obtainable
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Behrouz Parhampour, first email and then call phone: 02144925035
behrouz.parhampour@gmail.com
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What processes are involved for a request to access data/document
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Sending email and answering within 2 next weeks
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Comments
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