Cardiac Rehabilitation
Conditions
Brief summary
A two-parallel, evaluator-blind, single-center, randomized controlled trial was designed to assess the effectiveness of a home-based mobile guided exercise-based cardiac rehabilitation among patients undergoing Transcatheter Aortic Valve Replacement.
Detailed description
The purpose of our study was to investigate the effect of home-based mobile-guided exercise-based cardiac rehabilitation on the improvement of exercise capacity among patients undergoing transcatheter aortic valve replacement. 90 subjects will be recruited and followed up for a six-minute walk distance, short physical performance battery, exercise adherence, quality of life, frailty, nutritional status, sleep status, readmission rate, and all-cause mortality et al. The subjects will be invited to participate in on-site visits at 1, 3, and 6 months. Patients in the interventional group will receive a home-based mobile-guided exercise-based cardiac rehabilitation for 3 months. The home-based mobile-guided exercise-based cardiac rehabilitation is a multi-component intervention strategy including the preparation for discharge, family support, motivational interviews, health education, telephone follow-up, wearable devices, APP, et al. While the patients in the control group will receive routine care. For example, the preparation for discharge of the control group does not include the guidance of mobile-guided exercise-based cardiac rehabilitation, family support, and motivational interviews. After discharge, nurses will conduct telephone follow-ups once a month for the control group. Baseline data and outcomes will be collected in a Case Report Form.
Interventions
BEHAVIORALHome-based mobile guided exercise-based cardiac rehabilitation
Discharge preparation, telerehabilitation, scheduled onsite follow-ups, telephone follow-ups, self-reporting, health education, online communication, family and peer support, mailing letters, institutional referrals, and security management.
BEHAVIORALRoutine Care
Discharge preparation, scheduled onsite follow-ups, telephone follow-ups
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 60 years and ≤ 89 years old; * Patients scheduled to be discharged after TAVR; * Those who have the ability to read and write, and have normal speech and communication skills; * Patients and their families are willing to participate in this study; * Patients or family members have the ability to use mobile and an app.
Exclusion criteria
* Serious complications occur before discharge (such as major bleeding, stroke, valve detachment, moderate or above perivalve leakage, coronary artery occlusion, etc.) ; * Patients who are unable to participate in postoperative exercise rehabilitation due to limb dysfunction; * Being in palliative care or treatment; * Those with other Contraindication to exercise-based cardiac rehabilitation (such as resting ECG changes indicating significant ischemia, acute myocardial infarction or other acute cardiac events, unstable angina, uncontrolled arrhythmia, heart failure decompensation, etc.); * Currently participating in other rehabilitation projects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6-minute Walk Distance | Month 3 | Distance walked in 6 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6-minute Walk Distance | Month 6 | Distance walked in 6 minutes |
| Change in Short Physical Performance Battery (SPPB) | Month 3 and Month 6 | The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function. |
| Exercise Adherence Assessed by the Exercise Adherence Rating Scale (EARS) | Month1, Month 3 and Month 6 | Evaluated by the Exercise Adherence Rating Scale (EARS) |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORZhiyun Shen
Fudan University
Outcome results
None listed