Effects of Physical Training in Patients With Advanced Heart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Nove de Julho
About this trial
Heart failure is a condition where the heart cannot pump blood effectively. This can happen due to changes in the heart's structure or function, leading to symptoms like shortness of breath, fatigue, and reduced ability to exercise. These symptoms often worsen the patient's quality of life and increase hospital visits.
Exercise is known to help people with heart failure by improving blood flow to the muscles and increasing physical strength. Starting exercise early, even during hospitalization, may help prevent the negative effects of being inactive and improve recovery.
Some patients with advanced heart failure may need a heart transplant. While waiting for a transplant, these patients often receive intravenous medications to support heart function. However, they may become weaker and lose physical capacity during this time.
This study will test whether a supervised exercise program during hospitalization can help improve physical ability and exercise tolerance in patients with advanced heart failure who are on the heart transplant waiting list and receiving intravenous medication. The goal is to help these patients stay stronger and more stable while they wait for a transplant.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
heart failure regardless ; using positive inotropic support regardless of the dose administered, medical prescription to undergo physical therapy.
Disqualifiers
Patients under 18 years of age, atrial and ventricular arrhythmias that cause hemodynamic repercussions, patients with physical and/or cognitive limitations non-invasive ventilatory support to carry out the exercise.
Trial design
Design model
Single group
Treatments tested in this trial
physical training
Other interventionProtocol of aerobic and resistance exercises for patients with advanced heart failure on the heart transplant waiting list, and an evaluation of muscle strength, exercise tolerance, peripheral ultrasonography, and oxidative stress will be performed before and after completing 8 weeks of the protocol.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: EFFECTS OF PHYSICAL TRAINING IN PATIENTS WITH ADVANCED HEART FAILUREOther 1 intervention
Trial outcomes
Primary outcomes
1
The study aims to compare pre- and post-intervention 6MWT in a single-arm design. Sample size estimates will test 20-30m differences, assuming 0.5 correlation, SD of 42.4, and 5% type I error for power calculations.
The main objective of the study is to compare the six-minute walk test (6MWT) post-intervention with pre-intervention, using a one-arm intervention. The null hypothesis is that there are no differences between pre- and post-intervention. The alternative hypothesis will test differences of 20, 25, or 30 meters for possible sample size calculations. The dependence of pre- and post-measurements will be considered, represented by a correlation of 0.5. The standard deviation, which identified a value of 42.4. Considering a 5% type I error, we estimate possible sample sizes according to pre- and post-differences and the power of the test:
Time frame
2 days for evaluation, 8 weeks of rehabilitation protocol intervention, and 2 days for re-evaluationSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: