Verification of usefulness of cardiac telerehabilitation for elderly patients with heart failure

UMIN ID: UMIN000037560

Registered date:01/08/2019

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Heart failure
• Date of first enrollment: 2019/08/13
• Target sample size: 58
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Combination therapy of conventional outpatient CR and cardiac telerehabilitation

Outcome(s)

• Primary Outcome: Percentage of patients who improved peak VO2 by more than 6% after three months of CR
• Secondary Outcome: The rate of change of the following indicators during three months of CR 1. Peak VO2 2. Peak work rate 3. 6-minute walking distance 4. Brain natriuretic peptide 5. Body weight 6. Body composition 7. Nutritional index 8. Depression index 9. Serum lipid level 10. Blood sugar level, HbA1c 11. Renal function 12. Blood pressure 13. Heart failure self-care ability The following indicators during three months of CR 14. Physical activity 15. Rate of smoking cessation 16. Participation rate in CR

Key inclusion & exclusion criteria

• Age minimum: 60years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. NYHA class 4 2. Patients with LVEF of 40% or less who developed myocardial infarction within 90 days 3. History of syncope or cardiopulmonary arrest(CPA) with unknown cause or no treatment 4. History of syncope, CPA or ICD/CRT-D appropriate or inappropriate therapy within the past one year(Patients with implantable devices are excluded after April 24, 2020) 5. Unstable angina or lower threshold angina 6. Severe stenotic valvular disease 7. The Following adverse events occur when the exercise intensity is less than the anaerobic threshold at the time of symptom-limited exercise test or CR before cardiac telerehabilitation introduction 7.1 Nonsustained/sustained ventricular tachycardia or ventricular fibrillation 7.2 R on T type ventricular premature contraction (VPC) 7.3 Frequent VPC (more than 30%) 7.4 Couplet VPC (two or more times a minute) 7.5 Second- or third-degree atrioventricular block 7.6 progressive blood pressure drop during exercise 7.7 Vagal reflexes after exercise below the exercise prescription intensity (Vagal reflexes after symptom-limited exercise test are not included in the exclusion criteria) 8. Schedule within three months for cardiovascular surgery, and implantation of pacemakers (including CRT) and ICDs 9. Patients with ventricular assist devices 10. End-stage patients 11. Patients who have difficulty operating the cardiac telerehabilitation system 12. Patients who can not establish a telecommunication system at home 13. Patients who have difficulty in securing time for participation in CR due to working or schooling 14. Patients who have already participated in or plan to participate in other clinical trials (except for registry studies) 15. Patients for whom the study investigator or the attending physician judged inappropriate to participate in this study

Related Information

• Primary Sponsor: National Cerebral and Cardiovascular Center
• Secondary Sponsor: Remohab Inc.
• Source(s) of Monetary Support: Ministry of education, culture, sports, science and technology (Japan Society for the Promotion of Science)