Exercise-based Cardiac Rehabilitation Program on Hospitalized Heart Failure Patients Submitted to Cardiac Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Objective: To evaluate the effects of an early-based cardiac rehabilitation program on the functional capacity, inspiratory muscular strength and clinical outcomes in hospitalized heart failure patients before and after heart transplantation. Method: 30 hospitalized heart failure patients awaiting cardiac transplantation will be selected and randomized in 2 groups: conventional group (n = 15) - conventional exercise protocol: breathing exercises and global active exercises of upper and lower limbs in the sitting position; and Intervention group (n = 15) - cycle ergometer exercise protocol: each session consists of cycling on a stationary bicycle in the seated position for 20 minutes. In both groups, the exercise protocols will be applied twice a day until the hospital discharge, always supervised by a physiotherapist and a doctor. The evaluation procedures in all patients of the research will be: functional capacity measured by the 6 minute walk test and inspiratory muscle strength measured by manovacuometry. Evaluations will be repeated in 3 distinct moments: after 24h of hospital admission and/or clinical stabilization; before transplantation and after transplantation in hospital discharge.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Cardiac Rehabilitation (CR) on Functional Capacity and Cardiovascular Risk Factors

NCT02575976

Cardiovascular Disease Coronary Disease

COMPLETED NA

Effects a Rehabilitation Program in Patients With Left Ventricular Dysfunction After Coronary Artery Bypass Grafting

NCT02763774

Disorder; Heart, Functional, Postoperative, Cardiac Surgery

UNKNOWN NA

12-Week-Combined Physical Training In Heart Failure Patients

NCT02571270

Heart Failure Patients

COMPLETED NA

Activity Level and Barriers to Participate of Cardiac Rehabilitation in Advanced Heart Failure Patients

NCT03385837

Heart Failure，Congestive Cardiac Rehabilitation Physical Exercise

COMPLETED

The Research Aims to Study the Effectiveness of a Physical Exercise Program on Indicators of Quality of Life and Functionality: It Will be Applied at Home to People Undergoing Cardiac Surgery, in Phase II of Cardiac Rehabilitation

NCT07153874

Cardiac Surgery Rehabilitation Program Quality of Life +1 more

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure Transplant; Failure, Heart Physical Activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional exercise protocol

Conventional global exercise

Group Type EXPERIMENTAL

Conventional exercise protocol

Intervention Type OTHER

Breathing exercises and global active exercises of the upper and lower limbs while in the upright seated position

Cycle ergometer exercise protocol

Stationary cycle ergometer exercise

Group Type EXPERIMENTAL

Cycle ergometer exercise protocol

Intervention Type OTHER

Stationary cycle ergometer exercise while in the upright seated position for 20 minutes. The protocol will be performed intermittently with 5 periods; each period consists of 3 minutes of cycling followed by 1-minute of rest.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Conventional exercise protocol

Breathing exercises and global active exercises of the upper and lower limbs while in the upright seated position

Intervention Type OTHER

Cycle ergometer exercise protocol

Stationary cycle ergometer exercise while in the upright seated position for 20 minutes. The protocol will be performed intermittently with 5 periods; each period consists of 3 minutes of cycling followed by 1-minute of rest.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Heart Failure diagnosis determined by clinical presentation and confirmed on echocardiography by clinicians, with a left ventricular ejection fraction (LVEF) \< 40%
* New York Heart Association (NYHA) classes III and IV.

Exclusion Criteria

* chronic lung disease confirmed by pulmonary function testing
* unstable angina pectoris and acute coronary syndromes
* dialysis
* neuromuscular and psychiatric conditions that interfere in exercise

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No