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The purpose of this study is to determine if exercise training with or without testosterone replacement can improve cardiopathy in heart failure patients
In this study, we are evaluating:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise training | Other | Aerobic and strength exercise training |
|
| Testosterone replacement | Other | Testosterone replacement will be done quarterly |
|
| Testosterone replacement+Exercise | Other | Both Testosterone replacement and Exercise will done |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone replacement | Drug | Application quarterly of Testosterone Undecylate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microneurography | Muscle sympathetic nerve activity (MSNA) is recorded directly from the peroneal nerve using the microneurography technique. Multiunit postganglionic muscle sympathetic nerve recordings is made using a tungsten microelectrode. All of the recordings of MSNA met previously established and described criteria. MSNA is quantified as burst frequency (bursts per minute). | 4 months of exercise training/testosterone replacement |
| Forearm blood flow | Forearm blood flow is measured by venous occlusion plethysmography. The nondominant arm is elevated above heart level to ensure adequate venous drainage. A mercury-filled silastic tube attached to a low-pressure transducer is placed around the forearm and connected to a plethysmography. Forearm blood flow is determined on the basis of a minimum off four separate readings. Forearm vascular conductance is calculated by dividing forearm blood flow by mean arterial pressure times 100 and expressed in arbitrary units. | 4 months of exercise training/testosterone replacement |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiopulmonary exercise | The maximal cardiopulmonary test is carried out on a bike using a ramp protocol with workload increment every minute with energetic demand of about 1 metabolic equivalent(MET) per minute or 3.5 mL/Kg.min of oxygen uptake. | 4 months of exercise training/testosterone replacement |
| Body composition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Janieire N Alves, MD; PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Coração do Hospital da ClÃnicas da Universidade de Sao Paulo | São Paulo | São Paulo | 05403-900 | Brazil |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C010792 | testosterone undecanoate |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Exercise training | Other | Aerobic and strength exercise training |
|
Body composition and bone mineral density is determined by dual energy x-ray absorptiometry using densitometry equipment (Hologic), at the following regions: lumbar spine, femoral neck, total femur and total body. Appendicular lean mass is calculated as the sum of arms and legs lean soft tissue masses, assuming that all non-fat and non-bone tissue is skeletal muscle. The total body fat is expressed in grams and as a percentage of body weight. |
| 4 months of exercise training/testosterone replacement |
| Muscle biopsy | The muscle biopsy is obtained with a single entry into the muscle 5-10 minutes after administering the local anesthetic following an incision through the skin. A portion of the muscle (~10 mg) is processed to evaluate 1) muscle fiber type and 2) cross-sectional area | 4 months of exercise training/testosterone replacement |