Prospective study on safety of remote cardiac rehabilitation for patients after TAVI

JRCT ID: jRCTs032200122

Registered date:01/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients undergoing TAVI due to severe aortic valve stenosis
• Date of first enrollment: 14/05/2021
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Remote cardiac rehabilitation using remote monitoring system

Outcome(s)

• Primary Outcome: Safety of remote cardiac rehabilitation
• Secondary Outcome: Peak oxygen uptake, Anaerobic threshold, 6-minutes walk distanse, Knee extension strength, NT-proBNP, Steps (per day), Short Physical Performance Battery, controlling nutritional status, Remote cardiac rehabilitation implementation rate, Cardiovascular prognosis, Total death

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who will perform outpatient cardiac rehabilitation
2. Patients who were hospitalized at St. Marianna University Hospital, received transcatheter aortic valve transplantation, and started cardiac rehabilitation during hospitalization
3. Patients who gained document consent by free will of the research subject after having sufficient explanation for participation in this research, with sufficient understanding.
4. Men and women over 20 years old
5. Patients who can be accompanied by an attendant every time remote cardiac rehabilitation is performed

Exclude criteria

1. Patients who are NYHA class 3 or 4
2. Patients who had cerebral infarction after TAVI
3. Patients who had myocardial infarction within one month
4. Patients who have unknown or untreated syncope or cardiac arrest
5. Patients who had history of proper and inappropriate operation of ICD/CRT-D, syncope, and cardiopulmonary arrest within the last 6 months
6. Patients who have uncontrolled angina pectoris
7. Patients with adverse events due to exercise at the anaerobic threshold during the first symptom limited exercise test and out-patients cardiac rehabilitation
8. Patients who have severe renal dysfunction
9. Patients who have severe liver dysfunction
10. Patients who are difficult to operate the system of remote cardiac rehabilitation
11. Patients who do not have an internet communication system at home
12. Patients who have already participated in or plan to participate in other clinical trials during this trial
13. Patients who are not able to understand the significanse of clinical investigation because of the dementia or other psychiatric disease
14. Any other person who is deemed inappropriate by the Research Director

Related Information

• Primary Sponsor: Ashikaga Kohei
• Source(s) of Monetary Support: Japan heart club research grant