High-intensity Interval Training in Heart Failure Patients With Preserved Ejection Fraction

NCT03184311 | Unknown DMC

• 1 other identifier: 2019-00188
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effects of a 12-week high-intensity interval training (HIT) on exercise tolerance, functional status and quality of life in patients with chronic heart failure with preserved ejection fraction (HFpEF), in comparison to a control group undergoing a 12-week moderate-intensity continuous training.

Conditions

Heart Failure With Normal Ejection Fraction

Keywords

Therapy response prediction; Exercise tolerance; High-intensity interval training

Outcome Measures

Primary Outcomes (1)

• Change in peak oxygen uptake (VO2peak) due to training

  VO2peak will be measured by spiroergometry at the baseline and post-intervention visit: an incremental symptom-limited exercise test on an electronically operated bicycle ergometer (eBike, General Electric Company, Fairfield, Connecticut, USA) using a fixed ramp protocol (start at 10 watts, increase of 10 watts/minute) will be conducted. The test will be performed in an air-conditioned laboratory in the early afternoon under non-fasting conditions. After a 2-minute warm-up at 10 watts, patients will be instructed to pedal at a constant rate of 60 rpm to exhaustion or until signs of ischemia or serious cardiac arrhythmias appear. The exercise bout will be followed by a cool-down at 25 watts for 10 minutes or until HR is dropping down below 100 beats/minute. VO2peak will be defined as the highest value reached during exercise.

  Baseline and 12 weeks

Secondary Outcomes (17)

• Change in disease-specific biomarkers

  Baseline and 12 weeks

• Change in echocardiographic parameters of the left ventricular systolic and diastolic function

  Baseline and 12 weeks

• Change in arteriovenous oxygen difference (Da-vO2)

  Baseline and 12 weeks

• Change in pulse wave velocity (PWV)

  Baseline and 12 weeks

• Change in daily physical activity

  Baseline and 12 weeks

Study Arms (2)

High-intensity interval training (HIT)

EXPERIMENTAL

A 12-week HIT will be performed 3 times per week on a bicycle ergometer according to the protocol of Wisløff et al. In the first 4 weeks of the program, all sessions will consist of moderate continuous training (MCT) at 60-80% of peak heart rate (HRpeak) for 40 minutes in order that patients get used to exercising. For weeks 4-12, the following HIT protocol is intended: Patients will warm up for 10 minutes at moderate intensity (60-70% of HRpeak, Borg 11-13) before cycling four 4-minute intervals at high intensity (85-95% of HRpeak, Borg 15-17). Each interval will be separated by a 3-minute active pause at 60-70% of HRpeak (Borg 11-13). The training session will end with a 5-minute cool-down at moderate intensity (60-70% of HRpeak). Total exercise time will be 40 minutes.

Other: High-intensity interval training (HIT)

Moderate-intensity continuous training (MCT)

PLACEBO COMPARATOR

A 12-week MCT will be performed 3 times per week on a bicycle ergometer. All sessions will consist of moderate continuous training (MCT) at 60-70% of peak heart rate (HRpeak) for 47 minutes.

Other: Moderate-intensity contiuous training (MCT)

Interventions

High-intensity interval training (HIT) OTHER

Supervised 12-week HIT 3 times per week on a bicycle ergometer.

High-intensity interval training (HIT)

Moderate-intensity contiuous training (MCT) OTHER

Supervised 12-week MCT 3 times per week on a bicycle ergometer.

Moderate-intensity continuous training (MCT)

Eligibility Criteria

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

You may qualify if:

• Informed consent as documented by the patient's signature
• NYHA functional classes II-III
• Signs and symptoms of chronic HF:
• Dyspnea, paroxysmal nocturnal dyspnea
• Reduced exercise capacity, extended recovery after exercising
• Fatigue
• Peripheral edema (lower leg, ankle)
• EF (Ejection fraction) \>50%
• Structural or functional changes in echocardiography:
• LAVI (left atrial volume index) \>34 ml/m2 OR
• LVMI (left ventricular mass index) \>115 g/m2 (men), \>95 g/m2 (women) OR
• E/E' (ratio between mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E')) \>13 AND mean E' septal and lateral wall \<9 cm/s
• NT-proBNP \>125 pg/ml
• At least 4 weeks on stable medical treatment or without signs and symptoms of cardiac decompensation
• Trainable: Ventilatory threshold \>40% of predicted VO2max AND VO2peak \>10 ml/kg/min at the screening visit

You may not qualify if:

• Planned cardiac interventions in the following 6 months
• Unstable angina pectoris
• Paroxysmal atrial fibrillation
• Severe uncorrected valvular heart disease
• Uncontrolled brady- or tachyarrhythmia and hypertonic blood pressure
• Clinically significant concomitant disease states (e.g. advanced renal failure, hepatic dysfunction, insulin-dependent diabetes, COPD (chronic obstructive pulmonary disease) in grades III-IV, on-going cancer treatment)
• Significant musculoskeletal disease limiting exercise tolerance
• Active infection
• Immunosuppressive medical therapy
• Earlier hypersensitivity to parenteral iron preparation
• Anemia and iron deficiency due to active and/or chronic bleeding
• Blood transfusion within the previous 30 days
• Vulnerable persons (age \<18 years, pregnant and breastfeeding women)
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the study procedures due to insufficient language skills, psychological disorders, dementia, etc.

Sponsors & Collaborators

• University of Basel: lead
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator

Study Sites (1)

Department for Sport, Exercise and Health, Section Sports and Exercise Medicine, University of Basel

Basel, 4052, Switzerland

RECRUITING

Related Publications (1)

• Gasser BA, Boesing M, Schoch R, Brighenti-Zogg S, Kropfl JM, Thesenvitz E, Hanssen H, Leuppi JD, Schmidt-Trucksass A, Dieterle T. High-Intensity Interval Training for Heart Failure Patients With Preserved Ejection Fraction (HIT-HF)-Rational and Design of a Prospective, Randomized, Controlled Trial. Front Physiol. 2021 Sep 24;12:734111. doi: 10.3389/fphys.2021.734111. eCollection 2021.

  PMID: 34630155 DERIVED

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

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

Study Officials

• Arno Schmidt-Trucksäss, MD

  University of Basel

  PRINCIPAL INVESTIGATOR

• Thomas Dieterle, MD

  University of Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arno Schmidt-Trucksäss, MD

CONTACT

+41 61 2074741; arno.schmidt-trucksaess@unibas.ch

Thomas Dieterle, MMed

CONTACT

thomas.dieterle@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study personnel involved in the study measurements will be blinded to whether patients are allocated to the intervention or control group. Furthermore, the statistician will be blinded to treatment allocation. To ensure blinding, the study measurements will be performed in different rooms and by different staff than those involved in the training intervention. It is not possible to blind participating patients and investigators performing the randomization and training sessions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Model Details: * Intervention group: 12-week high-intensity interval training on a bicycle ergometer. * Control group: 12-week moderate-intensity continuous training on a bicycle ergometer.

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 12, 2017
• Study Start: July 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)