Completed

Exercise Training and Cardiac Resynchronization Therapy in Chronic Heart Failure Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to evaluate the impact of exercise training combined with cardiac resynchronization therapy on heart failure patients, focusing on improvements in clinical status, heart function, and exercise capacity.

What is being tested

Exercise training program

+ Cardiac resynchronization therapy (CRT)

BehavioralDevice
Who is being recruted

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorUniversity of Lisbon
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

This clinical trial focuses on heart failure patients who have recently undergone Cardiac Resynchronization Therapy (CRT), a treatment for moderate to severe heart failure. The main goal is to understand the effects of adding an exercise training (ExT) program to the CRT treatment. Heart failure patients often experience symptoms like shortness of breath, fatigue, and reduced exercise capacity. This study aims to improve these symptoms and overall quality of life by combining CRT with ExT. The study is particularly important for severe heart failure patients, as current research lacks information on the effects of this combined therapy for this group. During the trial, participants will follow an exercise training program that starts after their CRT. This program includes aerobic exercises, resistive exercises, and sensoriomotor exercises. The intensity of the exercises will gradually increase over time, allowing patients to improve their exercise capacity without causing undue stress or fatigue. The study will measure changes in heart function, exercise capacity, and quality of life. It will also evaluate the impact of the exercise program on the autonomic nervous system, which controls heart rate and blood pressure. The expected outcome is an improvement in symptoms, heart function, and overall quality of life for patients who participate in the exercise program.

Official TitleExercise Training Following Cardiac Resynchronization Therapy in Patients With Chronic Heart Failure
NCT02413151
Principal SponsorUniversity of Lisbon
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

62 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Patients with chronic heart failure (CHF), classified in NYHA functional class III or IV;

Receiving optimal medical therapy for CHF (including an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker and a beta-blocker unless a contraindication is evident) with a stable condition for more than 1 month (no hospitalization for HF, no change in medication, and no change in NYHA functional class);

Left ventricular ejection fraction (LVEF) < 35%;

QRS duration ≥ 120 ms.

4 exclusion criteria prevent from participating
If they are younger than 18 years or are unable to sign informed consent;

Patients who had been treated with an intravenous inotropic agent within the 30 days prior to implantation (these medications affect endothelial function after they are discontinued);

Unstable angina pectoris;

Orthopedic or neurological limitations to exercise.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The exercise sessions will be hospital-based, 3 times a week for 60 minutes each, on non-consecutive days for 6 months. Selected the aerobic interval training (AIT) method for the development of cardiopulmonary system and the inclusion of resistance and sensorimotores exercises. The AIT comprises 4 interval training periods (high intensity) and 3 active pauses (moderate intensity) between interval training periods.

Group II

Active Comparator
Regular lifestyle

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Santa Marta Hospital

Lisbon, PortugalOpen Santa Marta Hospital in Google Maps
CompletedOne Study Center