Though doctors have promoted the value of exercise for a variety of disorders for years, "exercise training has not been definitively established as safe in the group of patients who primarily have heart failure," said Dalane W. Kitzman M.D., a cardiologist who is principal investigator at Wake Forest Baptist, and colleagues, writing in the American Heart Journal.
"Controlled clinical trials have shown that exercise training improves physiological measurements" such as the distance that patients can walk in six minutes, they said after analyzing 14 trials. "None of these trials enrolled a sufficient number of patients to properly evaluate the impact of exercise training on death and hospitalization."
The new trial, called Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) "is the largest randomized clinical trial of exercise training ever performed," Kitzman said. "The trial represents a critical step in establishing exercise as a therapy for patients with left ventricular dysfunction" (reduced heart contractions).
He added, "The patient population enrolled in this trial will be a broad representation of heart failure patients, including large numbers of women, minorities and people from low socio-economic status."
"The HF-ACTION trial has been designed so that if the intervention is beneficial, the treatment can be translated rapidly into general practice," Kitzman said. In fact, the study leaders have met with Centers for Medicare & Medicaid Services, the office that assesses whether there is enough proof that a treatment is effective and safe in order to be paid for by Medicare, to help ensure that exercise programs would qualify for Medicare if the study is positive.
There are 84 clinical study sites in the trial across North America and Europe. At the Wake Forest Baptist site, 120 participants have been enrolled so far, the second-highest number across all sites.
The patients in the study will receive either exercise training or "usual care." Those in the exercise arm will receive 36 supervised exercise training sessions at a facility, using either bikes or walking. After the first 18 sessions, the patients will start home-based exercise, and will exercise exclusively at home after the second 18 sessions. They'll come back for facility-based training every three months.
The supervised training protocol is based on the traditional cardiac rehabilitation program of 36 sessions currently covered by insurers for patients after heart bypass surgery.
All patients in HF-ACTION will receive a self-management education program on topics such as medicines and their side effects, managing fluids, the importance of adhering to a low sodium diet.
The patients will be followed for up to four years through clinic visits, specialized tests, and telephone calls. In their comparison of the two groups, the investigators will record deaths and hospitalizations for all causes. They'll also measure changes in the maximum exercise time and quality of life.
Vinay Thohan, M.D., director of the heart failure service at Wake Forest Baptist, said "Five million Americans have heart failure with 550,000 new cases diagnosed each year. Despite optimal drug treatment, many heart failure patients die and others are faced with repeated hospitalizations, and have difficulty getting around, even for a few steps.
"Exercise training represents an intervention that if proven beneficial should be accessible to most heart failure patients due to its relatively low cost, high availability and ease of use," Thohan said.
Karen Richardson | EurekAlert!
Drone vs. truck deliveries: Which create less carbon pollution?
31.05.2017 | University of Washington
New study: How does Europe become a leading player for software and IT services?
03.04.2017 | Fraunhofer-Institut für System- und Innovationsforschung (ISI)
An international team of scientists has proposed a new multi-disciplinary approach in which an array of new technologies will allow us to map biodiversity and the risks that wildlife is facing at the scale of whole landscapes. The findings are published in Nature Ecology and Evolution. This international research is led by the Kunming Institute of Zoology from China, University of East Anglia, University of Leicester and the Leibniz Institute for Zoo and Wildlife Research.
Using a combination of satellite and ground data, the team proposes that it is now possible to map biodiversity with an accuracy that has not been previously...
Heatwaves in the Arctic, longer periods of vegetation in Europe, severe floods in West Africa – starting in 2021, scientists want to explore the emissions of the greenhouse gas methane with the German-French satellite MERLIN. This is made possible by a new robust laser system of the Fraunhofer Institute for Laser Technology ILT in Aachen, which achieves unprecedented measurement accuracy.
Methane is primarily the result of the decomposition of organic matter. The gas has a 25 times greater warming potential than carbon dioxide, but is not as...
Hydrogen is regarded as the energy source of the future: It is produced with solar power and can be used to generate heat and electricity in fuel cells. Empa researchers have now succeeded in decoding the movement of hydrogen ions in crystals – a key step towards more efficient energy conversion in the hydrogen industry of tomorrow.
As charge carriers, electrons and ions play the leading role in electrochemical energy storage devices and converters such as batteries and fuel cells. Proton...
Scientists from the Excellence Cluster Universe at the Ludwig-Maximilians-Universität Munich have establised "Cosmowebportal", a unique data centre for cosmological simulations located at the Leibniz Supercomputing Centre (LRZ) of the Bavarian Academy of Sciences. The complete results of a series of large hydrodynamical cosmological simulations are available, with data volumes typically exceeding several hundred terabytes. Scientists worldwide can interactively explore these complex simulations via a web interface and directly access the results.
With current telescopes, scientists can observe our Universe’s galaxies and galaxy clusters and their distribution along an invisible cosmic web. From the...
Temperature measurements possible even on the smallest scale / Molecular ruby for use in material sciences, biology, and medicine
Chemists at Johannes Gutenberg University Mainz (JGU) in cooperation with researchers of the German Federal Institute for Materials Research and Testing (BAM)...
19.06.2017 | Event News
13.06.2017 | Event News
13.06.2017 | Event News
27.06.2017 | Earth Sciences
27.06.2017 | Earth Sciences
27.06.2017 | Life Sciences