HIIT Effects on Long-term Survival in Heart Failure Patients

NCT05487716 | Completed

• 1 other identifier: 202200856B0
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

The American Heart Association announces that exercise training should be considered for all stable cardiac patients (Class I, Level A). Therefore, exercise is an important issue for cardiac patients. It has also been reported that high-intensity interval training (HIIT) brings benefits on reversal of cardiac remodeling and long-term survival for HF patients. This study explores high-intensity interval training (HIIT) effects on long-term survivals in heart failure (HF) patients, diagnosed according to the Framingham criteria. This retrospective cohort study is going to analyze HF patients diagnosed between January 1, 2009 and May 31, 2022 in a tertiary care hospital. All HF patients underwent the multidisciplinary disease management program (MDP) in the hospital were initially surveyed. Participants were further categorized into HF with reduced ejection fraction (HFrEF) (left ventricle ejection fraction \[LVEF\]\<40%), HF with mildly reduced EF (HFmrEF) (LVEF\>=40% and LVEF\< 50%), and HF with preserved EF (HFpEF) ( LVEF\>=50%) based on the initial 2-D echocardiography. Participants will be further divided into HIIT+MDP or MDP only in each group based on patient preference. Age, sex, body height, body weight, disease duration, etiology for HF, co-morbidities, and medication were documented during follow-up (F/U). B-type natriuretic peptide, natriuretic peptide (BNP), cardiopulmonary exercise test (CPET) for peak oxygen consumption (VO2peak) and 2-D echocardiography for LV geometry were repeatedly assessed during follow-up. The end-point is the death of the patients or the date of May 31, 2022. All mortality causes and overall survival rates will be determined at the end of F/U. HIIT effects on long-term survival (Kaplan-Meier survival curve) for patients with different heart failure phenotypes will be estimated by log rank test. Continuous variables between different groups were analyzed by student t-test, while continuous variables before and after HIIT within groups were assessed by paired t-test. Other non-continuous variables such as sex, and co-morbidities were compared by chi-square test.

Conditions

Morality; Remodeling, Ventricular; Heart Failure

Keywords

Aerobic exercise; Heart failure; Cardiac remodeling; Survival

Outcome Measures

Primary Outcomes (1)

• Mortality

  Death registration on our chart

  From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Secondary Outcomes (7)

• VO2peak in MET

  From date of inclusion until 12-16 weeks after inclusion date

• VE-VCO2 slope in (mL/min)/(mL/min)

  From date of inclusion until 12-16 weeks after inclusion date

• LVEF in %

  through study completion, up to 12 years

• LVEDD in mm

  through study completion, up to 12 years

• LVESD in mm

  through study completion, up to 12 years

Study Arms (1)

Heart failure patients (HF)

Subjects in HF were subgrouped according to their baseline left ventricular ejection fraction obtained by 2-D echocardiography as HFrEF (LVEF\<40%), HFmrEF (LVEF\>=40% and \<50%), and HFpEF (LVEF\>50%) Subjects underwent an additional 36 sessions of high-intensity interval training (alternating 80% and 40% peak oxygen consumption) were considered HIIT participants in each subgroup (HFrEF, HFmrEF, HFpEF). Others without exercise intervention were considered multidisciplinary disease management program (MDP) participants.

Behavioral: High-intensity interval training (HIIT)

Interventions

High-intensity interval training (HIIT) BEHAVIORAL

Included subjects who underwent an additional 36 sessions (2-3 sessions per week) of supervised bicycle ergometer (Ergoselect 150P, ergoline GmbH, Germany) training as in the previous protocol5 were classified as the HIIT participant. They exercised alternatively at 3-min interval of 80% VO2peak and 3-min interval of 40% VO2peak for 30 min each session.

Heart failure patients (HF)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Included subjects with divided into three subgroups * Heart failure with reduced ejection fraction (HFrEF): LVEF \<40%. * Heart failure with mildly reduced ejection fraction (HFmrEF): LVEF\>=40% and \< 50%. * Heart failure with preserved ejection fraction (HFpEF): LVELVEF\>=50%. Among each group * High-intensity interval training (HIIT) participants: Included subjects who underwent 36 sessions (2-3 sessions per week) of hospital-based supervised bicycle ergometer training with alternatively at 3-min interval of 80% VO2peak and 3-min interval of 40% VO2peak for 30 min each session for 3-4 months * Multidisciplinary disease managment program (MDP) participants: Included subjects without hospital-based HIIT.

You may qualify if:

• Patients with a diagnosis of heart failure according to the Framingham HF diagnostic criteria
• Stable heart failure clinical presentation for \> 4 weeks.

You may not qualify if:

• Pregnancy
• Chance of cardiac transplantation within 6 months
• Moderate to severe chronic obstructive pulmonary disease
• Uncompensated heart failure
• Estimated glomerular filtration rate \< 30 ml/min/1.73m\^2
• Absolute contraindications for exercise suggested by the American College of Sports Medicine
• Unable to perform exercise caused by non-cardiac disease

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chih-Chin Hsu

Keelung, 204, Taiwan

Location

MeSH Terms

Conditions

Ventricular Remodeling; Heart Failure

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Chih-Chin Hsu, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: August 4, 2022
• Study Start: January 1, 2009
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-07

Locations

TW (1)