Effects of Physical Training in Patients With Advanced Heart Failure

NCT07501143 | Not Yet Recruiting DMC

• 2 other identifiers: heart failure and exercise89443225.4.0000.5462
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insuficiência Cardíaca; Transplante Cardíaco; Exercício Físico

Keywords

Heart Failure, Heart Transplant; Physical Exercise

Outcome Measures

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:

  2 days for evaluation, 8 weeks of rehabilitation protocol intervention, and 2 days for re-evaluation

Study Arms (1)

EFFECTS OF PHYSICAL TRAINING IN PATIENTS WITH ADVANCED HEART FAILURE

OTHER

Endurance training

Other: physical training

Interventions

physical training OTHER

Protocol 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.

EFFECTS OF PHYSICAL TRAINING IN PATIENTS WITH ADVANCED HEART FAILURE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• heart failure regardless ; using positive inotropic support regardless of the dose administered, medical prescription to undergo physical therapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

235 Vergueiro Street

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Luciana Malosá Sampaio

  Nove de Julho University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana Malosá Sampaio Luciana Malosá Sampaio, lead researcher

CONTACT

+55 11 996002075; lucianamalosa@uni9.pro.br

Lilian Oliveira dos Santos principal investigator, principal investigator

CONTACT

+55 11 952001738; lilian.o.santos@uni9.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pofessor Doctor

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: May 30, 2026
• Primary Completion: June 30, 2026
• Study Completion (Estimated): October 31, 2029
• Last Updated: April 8, 2026

Record last verified: 2026-03

Locations

BR (1)