Comparison of the Effect of Two Types of Physical Exercises in Patients With Heart Failure With Preserved Ejection Fraction

NCT05726474 | Completed

• 1 other identifier: SBPLY/21/180501/000112
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Heart failure (HF) is a chronic disease with a very important and increasingly severe social and health impact with a prevalence of 6.8% in Spain. HF with preserved ejection fraction (HFpEF) represents approximately 50% of all patients with HF. In the absence of pharmacological treatments that have succeeded in reducing mortality or morbidity in this pathology, it is recommended that interventions be directed at prevention, symptomatic treatment of HF and treatment of comorbidities to avoid exacerbations, thus physical exercise is recognized as an important adjunct in the treatment of HF and is recommended by the guidelines of the American College of Cardiology (ACC)/American Heart Association (AHA) and the European Society of Cardiology (ESC). Currently, aerobic exercise is the most studied physical exercise in this population, but in recent years high-intensity interval training (HIIT) and the combination of aerobic exercise with strength training (combined exercise) have emerged. Objectives: The overall objective of this study is to compare the effectiveness of combined training and HIIT on exercise capacity, diastolic function, endothelial function, and arterial stiffness in patients with HFpEF. The specific objectives of this study are: a) to compare the effectiveness of combined training and HIIT on quality of life in patients with HFpEF and b) to analyze the cost-effectiveness of combined training and HIIT versus conventional treatment in patients with HFpEF. Methodology: The ExIC-FEp study will be a single-blind randomized clinical trial with 3 arms (combined exercise, HIIT and a control group), conducted at the Health and Social Research Center of the University of Castilla-La Mancha, to analyze two types of supervised physical exercise in patients with HFpEF for 6 months. Patients with HFpEF will be randomly assigned (1:1:1) to the combined exercise, HIIT or control group. All participants will be examined, at baseline (prior to randomization), at three months (mid-intervention) and at six months (at the end of the intervention). Participants will undergo physical examination, echocardiography, maximal cardiopulmonary stress test, and measurement of endothelial function and arterial stiffness. In addition, sociodemographic variables, quality of life, physical activity, adherence to the Mediterranean diet, strength, spirometry and blood sampling will be measured. Expected scientific contributions: this randomized clinical trial will represent a a significant advance in the scientific evidence available on the efficacy of physical exercise in the treatment of HFpEF, through: (a) transfer of the results to physicians, nurses and patients; (b) dissemination of results through scientific articles, doctoral theses and participation in congresses; (c) press releases and press conferences with the aim of disseminating the research results to the population; (d) dissemination through social networks to improve the social impact; and (e) design and content development of a web page.

Conditions

Heart Failure; Physical Exercise; Exercise Capacity; Diastolic Function; Endothelial Function; Arterial Stiffness

Outcome Measures

Primary Outcomes (16)

• Exercise capacity

  Maximal cardiopulmonary stress test with Ergoline600 ergometer bicycle.

  Change from Baseline exercise capacity at 3 months

• E velocity

  E velocity in m/s

  Change from Baseline E velocity at 3 months

• Endothelial function

  Carotid intima-media thickness: by ultrasound with the Sonosite SII device.

  Change from Baseline endothelial function at 3 months

• Arterial stiffness

  Pulse wave velocity and augmentation index

  Change from Baseline arterial stiffness at 3 months

• A velocity

  A velocity in m/s

  Change from Baseline A velocity at 3 months

• E/A ratio

  E/A ratio

  Change from Baseline E/A ratio at 3 months

• e' velocity

  e' velocity in m/s

  Change from Baseline e' velocity in m/s at 3 months

• E/e' ratio

  E/e' ratio

  Change from Baseline E/e' ratio at 3 months

• ejection fraction

  percentage of ejection fraction

  Change from Baseline ejection fraction at 3 months

• left ventricular volume index

  left ventricular volume index

  Change from Baseline left ventricular volume index at 3 months

• end-diastolic volume

  end-diastolic volume

  Change from Baseline end-diastolic volume at 3 months

• left ventricular mass

  left ventricular mass

  Change from Baseline left ventricular mass at 3 months

• left atrial diameter

  left atrial diameter

  Change from Baseline left atrial diameter at 3 months

• isovolume relaxation time

  isovolume relaxation time in seg

  Change from Baseline isovolume relaxation time at 3 months

• deceleration time

  deceleration time in m/s

  Change from Baseline deceleration time at 3 months

• left atrial volume index

  left atrial volume index

  Change from Baseline left atrial volume index at 3 months

Secondary Outcomes (23)

• Sociodemographic variables

  Baseline

• Patient's medical history

  Baseline

• Weight

  Change from Baseline weight at 3 months

• Muscular strength

  Change from Baseline Muscular strength at 3 months

• Spirometry

  Change from Baseline spirometry at 3 months

Study Arms (3)

Combined exercise

EXPERIMENTAL

Behavioral: Combined exercise

High interval training

EXPERIMENTAL

Behavioral: High interval training

Usual care

NO INTERVENTION

Interventions

Combined exercise BEHAVIORAL

Patients will exercise for 40 minutes three times a week on an ergometric bicycle at 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, without ergometer at 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, without shortness of breathing difficulty. In addition, strength training will be performed (bench press, leg press, leg curl, leg machine, bench press, leg press, leg curl, leg curl, leg machine). leg curls, leg curls, rowing machine, triceps dips, pectoral pull-ups) twice a week. week. Strength training will be performed with 15 repetitions per exercise and per session, with a corresponding workload of 15 repetitions. session, with a workload corresponding to 60% to 65% of the 1-repetition maximum (1RM) measured at (1RM) measured at the beginning and at the end of the intervention.

Combined exercise

High interval training BEHAVIORAL

Patients will perform three training sessions per week. Each training session begins with a 10-minute warm-up at moderate intensity (corresponding to 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, no shortness of breath) before cycling, four 4-minute intervals at high intensity (corresponding to 85-90% of VO2max, 90-95% of HRmax, 15-17 on the Borg scale, shortness of breath). Each interval will be separated by 3 minutes of active pauses, with a HRmax of 50-70%. The training session will end with 3 minutes of cool down at moderate intensity (corresponding to 50-60%). moderate intensity (corresponding to 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, without difficulty). Borg scale, no shortness of breath). The total exercise time will be 40 minutes for the HIIT group.

High interval training

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart Failure with preserved ejection fraction picture (diagnosis according to ESC 2021 criteria)
• Signs and symptoms of Heart Failure
• A left ventricular ejection fraction of ≥50%.
• Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of left ventricular diastolic dysfunction/elevated left ventricular filling pressures, including elevated natriuretic peptides.
• Sedentary men and women (structured exercise \<2 x 30 min/week).
• Age ≥40 years
• Written informed consent
• Clinically stable for 6 weeks
• Optimal medical treatment for ≥6 weeks

You may not qualify if:

• Non-cardiac causes of heart failure symptoms:
• Significant valvular or coronary artery disease - Uncontrolled hypertension or arrhythmias.
• Primary cardiomyopathies
• Significant pulmonary disease (FEV1\<50% predicted, GOLD III-IV)
• Inability to exercise or conditions that may interfere with exercise intervention.
• Myocardial infarction in the last 3 months
• Signs of ischaemia during maximal cardiopulmonary exercise test.
• Comorbidity that may influence one-year prognosis 7. Participation in another clinical trial.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

Universidad de Castulla-La Mancha

Cuenca, Cuenca, 16001, Spain

Location

Related Publications (1)

• Cavero-Redondo I, Saz-Lara A, Bizzozero-Peroni B, Nunez-Martinez L, Diaz-Goni V, Calero-Paniagua I, Matinez-Garcia I, Pascual-Morena C. Accuracy of the 6-Minute Walk Test for Assessing Functional Capacity in Patients With Heart Failure With Preserved Ejection Fraction and Other Chronic Cardiac Pathologies: Results of the ExIC-FEp Trial and a Meta-Analysis. Sports Med Open. 2024 Jun 18;10(1):74. doi: 10.1186/s40798-024-00740-6.

  PMID: 38886304 DERIVED

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: February 14, 2023
• Study Start: January 23, 2023
• Primary Completion: September 30, 2024
• Study Completion: May 15, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)