Evaluation of the efficacy and safety of an integrated telerehabilitation platform for home-based cardiac REHABilitation in patients with heart failure (E-REHAB)

JRCT ID: jRCT2052200064

Registered date:13/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Heart failure, angina pectoris, after open heart surgery, aortic disease, peripheral artery disease
• Date of first enrollment: 26/04/2021
• Target sample size: 128
• Study type: Interventional
• Intervention(s): Home-based cardiac rehabilitation using RH-01 or center-based cardiac rehabilitation for 12 weeks

Outcome(s)

Primary Outcome

Change in 6-minute walk distance from the screening to the end of the intervention period*
*It is not set to be primary outcome for patients with angina pectoris, after open heart surgery, aortic diseases or peripheral arterial disease

Secondary Outcome

1)Change in knee-extensor muscle strength from primary registration to 20 weeks after
2)Change in NT-proBNP from primary registration to 20 weeks after
3)Change in Peak VO2 from baseline (day of discharge) to 20 weeks after
4)Implementation rate of CR from the start of the intervention period to 20 weeks after
5)Change in KCCQ from secondary registration (day of allocation) to 20 weeks after
6)Change in SF-36 from secondary registration to 20 weeks after
7)Change in score for HADS (Hospital Anxiety and Depression Scale) from primary registration to 20 weeks after
8)Success rate of home-based CR using RH-01 for 20 weeks
9)Number of hospital visits from secondary registration to 20 weeks after
10)Unexpected hospital visits due to worsening heart failure from secondary registration to 20 weeks after
11)Re-hospitalization due to HF and days lost due to hospitalization from the day of discharge to 20 weeks after

Key inclusion & exclusion criteria

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

Include criteria

1) Patients who are hospitalized with diagnosis of heart failure*a
2) Indication of cardiac rehabilitation in outpatient setting
3) 6 minutes walk distance for 200m or more and less than 550m*b
4) New York Heart Association class 2 or 3*c
5) Patients who are age 20 years and over at the day informed consent obtained
6) Patients who can obtain document consent with their own will before any study related procedure

a)The safety assessment cohort "other than heart failure" is replaced with "angina pectoris, after open heart surgery, aortic disease or peripheral arterial disease"
b)c) Not applied to patients with angina pectoris, after open heart surgery, aortic disease or peripheral arterial disease

Exclude criteria

Primary registration
1)Patients who do not have or prepare good net environments at their own home
2)Patients with contraindication of exercise
3)Patients who can not pedal cycle ergometers due to other diseases or pain
4)Patients who have difficulties in using the application of this trial due to vision impairment or hardness of hearing
5)Patients who experienced low blood pressure, lethal arrhythmia or other adverse events under cardiac rehabilitation, exercise stress test or exercise treatment
6)Patients who are planned to take inpatient cardiac rehabilitation program for 4 weeks and over
7)Acute myocardial infarction patients with untreated significant coronary stenosis (75% or more) in the main three branches [American Heart Association: # 1,2,3,5,6,7,11,13]
8)Patients who are planned to undergo cardiovascular operation or procedure within 24 weeks from the day obtained informed consent for the treatment
9)Patients who are planned to undergo cardiac transplantation within 24 weeks from the day obtained informed consent
10)Patients who have been performing intermediate or intensive exercise regularly (once a week or more) within past 6 weeks from the day obtained informed consent
11)Advanced heart failure
12)End-stage kidney disease (estimated GFR <15 ml/min/1.73m2)
13)End-stage liver disease
14)Severe Aortic stenosis
15)Patients who are suggested to be residual myocardial ischemia
16)Uncontrolled heart failure
17)Patients who are inplaneted the left ventricular assist device
18)Life expectancy would be 6 months and over
19)Patients who participate in other clinical trial or clinical study within past 12 weeks before the day obtained informed consent
20)Patients who are judged not to be able to follow the significance or observe compliance of this trial due to dementia or mental disorders by the principal investigators or sub investigators
21)Patients who are judged to be ineligible to this trial with other reasons by the principal investigators or sub investigators

Secondary registration
1)Patients who do not have or prepare good net environments at their own home
2)Patients who experienced low blood pressure, lethal arrhythmia or other adverse events under cardiac rehabilitation, exercise stress test or exercise treatment
3)Patients who took inpatient cardiac rehabilitation program for more than 4 weeks
4)Patients who are extended their hospitalization by unexpected reason
5)Patients who participated outpatient cardiac rehabilitation program less than 4 times during run-in period
6)Patients who are judged to be ineligible to this trial with other reasons by the principal investigators or sub investigators

Related Information

• Primary Sponsor: Sakata Yasushi
• Secondary Sponsor: Remohab.Inc.,AMED