Effect of Physical Training in Patients With Heart Failure Caused by Chemotherapy for Cancer Treatment
- Conditions
- Heart FailureCardiotoxicityCancerInsufficiency;Cardiac
- Interventions
- Other: exercise training
- Registration Number
- NCT04047901
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief Summary
New therapies for cancer increased patient survival, but led to the recognition of adverse effects associated with cancer treatment, such as the use of chemotherapy. Cardiotoxicity is the most significant adverse effect, which affect the functional capacity and quality of life and is associated with high morbidity and mortality, regardless of the oncological prognosis. One of the manifestations of cardiotoxicity is ventricular dysfunction that can lead to heart failure. Neuro humoral hyperactivation with increased sympathetic nerve activity is a typical manifestation of heart failure and is associated with worse prognosis. Studies have shown that physical training significantly reduces sympathetic nerve activity in addition to improving muscle blood flow, reversing effects on skeletal muscle and improving quality of life. The hypothesis is that physical training may reduce sympathetic nerve activity and vasoconstrictor status in patients with heart failure caused by anthracyclines, as well as improving baroreflex and chemoreflex sensibility, mechanoreflex and metaborreflex control and skeletal myopathy.
- Detailed Description
The investigators included patients\> 18 years, left ventricular ejection fraction \<= 0.55, functional class (NYHA) I-III, under medical treatment for heart failure. Patients with coronary artery disease, moderate to severe valve disease, positive Chagas serology, inability to participate in an exercise program are excluded.
Primary outcome: Muscle sympathetic nerve activity Secondary outcome: arterial baroreflex sensitivity, peripheral chemorreflex sensitivity, mecanic and muscuclar metaborreflex control, ubiquitin proteasome system activity.
Patients were divided into 2 groups-trained (n = 10) and non-trained (n = 10). Patients in the trained group will complete 16 weeks of aerobic training. Evaluation of cardiac function, functional capacity, quality of life and biochemical evaluation (troponin, hs-CRP and BNP). For muscle evaluation will be performed biopsy of the vastus lateralis muscle
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- age 18 years old
- Funcional Class I-III (NYHA)
- Ejection fraction < o,55
- treated for heart failure
- Coronary artery disease
- Moderate to major valve disease
- Positive serology for Chagas
- Inability to perform physical exercises
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Training group exercise training Patients will complete 16 weeks of training including 40 minutes of aerobic training, 15 minutes of resistive exercise and 5 minutes of relaxation.
- Primary Outcome Measures
Name Time Method Measure muscular sympathetic nervous activity 16 weeks The sympathetic nervous activity is assessed by the microneurography technique
- Secondary Outcome Measures
Name Time Method Evaluate quimiorreflex sensibility 16 weeks Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique
Evaluate Mecanorreflex control 16 weeks Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique
Evaluate baroreflex activity 16 weeks Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique
Evaluate metaborreflex control 16 weeks Evaluation of muscular sympathetic nervous activity at rest by the technique of microneurography, evaluation of the muscular blood flow by venous occlusion plethysmography technique
Evaluation of skeletal myopathy 16 weeks muscle biopsy
Trial Locations
- Locations (1)
Heart Institute of University of São Paulo
🇧🇷São Paulo, Sao Paulo, Brazil