Clinical trial NCT05989594: Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing TAVR
Official title: A Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing Transcatheter Aortic Valve Replacement (REHAB-TAVR): a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Rehabilitation
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in 6-minute Walk Distance
timeFrame: Month 3
Secondary outcomes:
measure: Change in 6-minute Walk Distance
timeFrame: Month 6
measure: Change in Short Physical Performance Battery (SPPB)
timeFrame: Month 3 and Month 6
measure: Exercise Adherence Assessed by the Exercise Adherence Rating Scale (EARS)
timeFrame: Month1, Month 3 and Month 6
Other outcomes:
measure: All-cause Rehospitalizations and death
timeFrame: Month 3 and Month 6
measure: Handgrip Strength
timeFrame: Month 3 and Month 6
measure: Frailty Status Assessed by the Fried Frailty Criteria
timeFrame: Month 3 and Month 6
measure: Frailty Status Assessed by the Essential Frailty Toolset
timeFrame: Month 3 and Month 6
measure: Cognitive Function Assessed by the Mini-mental State Examination
timeFrame: Month 3 and Month 6
measure: Quality of Life Assessed by the EuroQol 5-dimension 5-level (EQ-5D-5L)
timeFrame: Month 3 and Month 6
measure: Nutrition Status Assessed by the Mini-Nutritional Assessment
timeFrame: Month 3 and Month 6
measure: Anxiety Assessed by the General Anxiety Disorder-7 （GAD-7）
timeFrame: Month 3 and Month 6
measure: Depression Assessed by the Geriatric Depression Scale (GDS-15)
timeFrame: Month 3 and Month 6
measure: Sleep Assessed by the Pittsburgh Sleep Quality Index
timeFrame: Month 3 and Month 6
measure: Functional capacity Assessed by the Duke Activity Status Index (DASI)
timeFrame: Month 3 and Month 6
measure: Economic Analysis Assessed by direct medical costs, direct non-medical costs, and the cost of rehabilitation therapy.
timeFrame: Month 3 and Month 6
measure: Body Mass Index (BMI)：weight and height will be combined to report BMI in kg/m^2
timeFrame: Month 3 and Month 6
measure: Systolic and Diastolic Blood Pressure Assessed by a medical electronic sphygmomanometer at the outpatient.
timeFrame: Month 3 and Month 6
measure: Heart Rate Calculated by the number of heartbeats per minute.
timeFrame: Month 3 and Month 6
measure: New York Heart Association classification (NYHA) Presented by LevelⅠ, LevelⅡ, Level Ⅲ, Level Ⅳ.
timeFrame: Month 3 and Month 6
measure: Symptoms and Signs Assessed by the patients' self-reported whether they have palpitations, chest tightness, chest pain, dyspnea, edema, fatigue, loss of appetite, or other symptoms and signs that need to be elaborated on in detail.
timeFrame: Month 3 and Month 6
measure: Left Ventricular Ejection Fraction Assessed by the echocardiogram and presented by the unit of percentage (%)
timeFrame: Month 3 and Month 6
measure: Biomarkers for the cardiac function Assessed by N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) and Cardiac Troponin T (cTnT)
timeFrame: Month 3 and Month 6
measure: Biomarkers for renal function Assessed by Estimated Glomerular Filtration Rate (eGFR).
timeFrame: Month 3 and Month 6
measure: Biomarkers for serum lipid levels Assessed by Triglyceride (TG), Cholesterol (CHOL), Low-Density Lipoprotein Cholesterol (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C).
timeFrame: Month 3 and Month 6
measure: Red Blood Cells (RBC)
timeFrame: Month 3 and Month 6
measure: Haemoglobin (HGB)
timeFrame: Month 3 and Month 6
measure: White Blood Cells (WBC)
timeFrame: Month 3 and Month 6
measure: Blood platelets (PLT)
timeFrame: Month 3 and Month 6
measure: Biomarkers for coagulation function Assessed by Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT).
timeFrame: Month 3 and Month 6
measure: Social support Assessed by the Lubben Social Network Scale-6 (LSNS-6)
timeFrame: Month 3 and Month 6
Locations:
Study officials:
affiliation: Fudan University
name: Zhiyun Shen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Newman-Beinart NA, Norton S, Dowling D, Gavriloff D, Vari C, Weinman JA, Godfrey EL. The development and initial psychometric evaluation of a measure assessing adherence to prescribed exercise: the Exercise Adherence Rating Scale (EARS). Physiotherapy. 2017 Jun;103(2):180-185. doi: 10.1016/j.physio.2016.11.001. Epub 2016 Nov 9.
citation: Nagatomi Y, Ide T, Higuchi T, Nezu T, Fujino T, Tohyama T, Nagata T, Higo T, Hashimoto T, Matsushima S, Shinohara K, Yokoyama T, Eguchi A, Ogusu A, Ikeda M, Ishikawa Y, Yamashita F, Kinugawa S, Tsutsui H. Home-based cardiac rehabilitation using information and communication technology for heart failure patients with frailty. ESC Heart Fail. 2022 Aug;9(4):2407-2418. doi: 10.1002/ehf2.13934. Epub 2022 May 9.