Exercise-induced Epigenetic Adaptations

NCT07582094 | Completed

• 2 other identifiers: 201902170A3109-2314-B-182-026-MY3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Among all patients, aged between 20 and 80 years old, with heart failure (HF) underwent guideline-directed medical therapy (GDMT) in a tertiary care hospital, 40 of them with stable clinical status greater than 4 weeks were sequentially enrolled in the study. Thery were further allocated into the high-intensity interval training (HIIT) and GDMT groups. The 20 HIIT participants underwent additional 36 sessions of exercise training with alternating 80% of peak oxygen consumption (VO2peak) and 40% of VO2peak for 30 mins, whereas the remaining 20 GDMT participants received regular medication treatement. Baseline clinical information was recorded. Cardiopulmonary exercise test (CPET), 2-D echocardiography, bioimpedance analysis, questionnaire for quality of life, serum b-type natriuretic peptide (BNP), circulating microRNA (miRNA) profile and serum metabolomics before intervention were assessed. Cardiomyocytes and/or cardiac fibroblasts were harvested in 10% patient serum for cell activities, western blot, and messenger RNA studies. All the above examinations were followed after completing the exercise training in HIIT participants and 3-4 months after initial visit in GDMT participants. Parametric anslysis was used to assess the differences of continuous parameters with normal distributions. Those without normal distributions were estimated with non-parametric analysis. 2x2 ANOVA was conducted to compare differences of the circulating miRNA between the two groups of participants before and after interventions. Non-continous parameters between the two groups were assessed by chi-square test.

Conditions

Heart Failure

Keywords

Heart failure; MicroRNAs; Metabolomics; Exercise; Ventricular remodeling

Outcome Measures

Primary Outcomes (16)

• Peak oxygen consumption (VO2peak)

  Peak oxygen consumpation in metabolic equivalent (MET) obtained from the cardiopulmonary exercise test.

  4 months

• Oxygen uptake efficiency slope (OUES)

  OUES in mL/min per log L/min obtained from the cardiopulmonary exercise test.

  4 months

• minute ventilation to minute CO2 ventilation slope (Ve-VCO2)

  Ve-VCO2 slope obtained from the cardiopulmonary exercise test.

  4 months

• Heart rate reserve (HRR)

  heart rate reserve in beat per minute obtained from the cardiopulmonary exercise test

  4 months

• Left ventricular ejection fraction (LVEF)

  LVEF in % obtained 2-D echocardiography

  4 months

• Left ventricle end-diastolic volume (LVEDV)

  LVEDV in mL obtained 2-D echocardiography

  4 months

• Left ventricle end-systolic volume (LVESV)

  LVESV in mL obtained from 2-D echocardiography

  4 months

• Left ventricle mass (LVM)

  LVM in gram obtained from 2-D echocardiography

  4 months

• Left ventricle mass index (LVMI)

  LVMI in kg/m\^2 obtained from 2-D echocardiography

  4 months

• early diastolic mitral inflow velocity-to-early diastolic mitral annular tissue velocity ratio (E/e')

  E/e' obtained from 2-D echocardiography

  4 months

• b-type natriuretic peptide (BNP)

  BNP in pg/mL obtained from participant's serum

  4 months

• Appendicular skeletal muscle index (ASMI)

  ASMI in kg/m\^2 obtained from bioimpedance analysis

  4 months

• skeletal muscle mass (SMM)

  SMM in % obtained from bioimpedance anslysis divided by body weight

  4 months

• body fat mass (BFM)

  BFM in % obtained from bioimpedance anslysis divided by body weight

  4 months

• Physical component score (PCS)

  Medical Outcomes Study Short Form-36 health survey for physical health in quality of life

  4 months

• Mental component score (MCS)

  Medical Outcomes Study Short Form-36 health survey for mental health in quality of life

  4 months

Study Arms (2)

GDMT

NO INTERVENTION

Patients with heart failure (HF) had stable clinical presentations for greater than 4 weeks and received individualized patient education under optimized guideline-directed medical therapy by our HF care team. The HF care team provided only individualized education related to HF and methods for self-monitoring, optimized guideline-based HF medication, and further laboratory assessments (Lee et al. Int Heart J. 2012;53:364-369). The GDMT participants did not have any additional training programs.

HIIT

EXPERIMENTAL

Patients with heart failure (HF) had stable clinical presentations for greater than 4 weeks and received individualized patient education under optimized guideline-directed medical therapy by our HF care team. The HF care team provided only individualized education related to HF and methods for self-monitoring, optimized guideline-based HF medication, and further laboratory assessments (Lee et al. Int Heart J. 2012;53:364-369). In addition to the GDMT, the HIIT participants underwent additional 36 sessions of alternating 3-min of 80% peak oxygen consumption (VO2peak) and 3-min of 40% VO2peak for 30-min.

Behavioral: high-intensity interval training

Interventions

high-intensity interval training BEHAVIORAL

The participants underwent 36 sessions of alternating 3-min of 80% peak oxygen consumption (VO2peak) and 40% VO2peak for 30-min

HIIT

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with heart failure, diagnosed according to the Framingham HF diagnostic criteria (McKee et al. N Engl J Med 1971, 285:1441-1446), who had stable clinical presentations greater than 4 weeks and received individualized patient education under optimized guideline-based management (Mao et al. J Cardiovasc Med (Hagerstown) 2015, 16:616-624), were initially surveyed.

You may not qualify if:

• Individuals aged \<20 years and \>80 years
• Pregnancy
• Cardiac transplantation within the next 6 months
• Moderate to severe chronic obstructive pulmonary disease
• Decompensated HF
• Non-cardiac disease prohibiting cycling exercise
• Estimated glomerular filtration rate of \< 30 mL/min/1.73 m\^2
• Absolute contraindications for exercise suggested by the American College of Sports Medicine (Pescatello et al. ACSM's guidelines for exercise testing and prescription. 9th ed. Philadelphia, PA.: Wolters Kluwer/Lippincott Williams \& Wilkins; 2014).

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Keelung Chang Gung Memorial Hospital

Keelung, 204, Taiwan

Location

MeSH Terms

Conditions

Heart Failure; Motor Activity; Ventricular Remodeling

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

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

  Department of Physical Medicine and Rehabilitation, Keelung Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The care provider did not know the classification of the included participants. The GDMT participants did not know the treatment plan of the HIIT participants and vice versa.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We compares the pre- and post-high-intensity interval training (HIIT) effects between pateients with heart failure (HF) underwent guideline-directed medical therapy (GDMT) and those with additional HIIT. All patients with HF under GDMT in a tertiary care hospital were sequentially recruited. Among these participants, part of them were allocated to receive the regular medical treatment, and part of the remaining participants underwent additional 36 sessions of high-intensity interval training. Exercise performance, left ventricle morphology, body compositions, serum b-type natriuretic peptide, circulating microRNA, and serum metabolomics in the two groups before and after interventions were compared. We also compared cardiomyocytes and/or cardiac fibroblasts behaviors harvested in the serum obtained from before and after interventions in the two groups of participants.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: August 1, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2023
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)