Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing TAVR

Cardiac Rehabilitation Clinical Trial

— REHAB-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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05989594
• Other study ID #: B2022-062R
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Shanghai Zhongshan Hospital
• Contact: Zhiyun Shen
• Phone: +8318317089276
• Email: Shen.zhiyun[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Rehabilitation

Intervention

Behavioral:
• Home-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.
• Routine Care
Discharge preparation, scheduled onsite follow-ups, telephone follow-ups

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

References & Publications (2)

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 informatio — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All-cause Rehospitalizations and death	The combined number of all-cause rehospitalizations and death 3 and 6 months after discharge.	Month 3 and Month 6
Other	Handgrip Strength	Handgrip strength is measured in kilograms by a handgrip dynamometer.	Month 3 and Month 6
Other	Frailty Status Assessed by the Fried Frailty Criteria	The Fried criteria consists of 5 components: low physical activity, exhaustion, weakness, slowness, and unintentional weight loss. The presence of 3 or more Fried criteria indicates frailty, 1-2 criteria indicates pre-frailty, and 0 criteria indicates no frailty.	Month 3 and Month 6
Other	Frailty Status Assessed by the Essential Frailty Toolset	The EFT is scored 0 (least frail) to 5 (most frail) based on the following 4 items: pre-procedural anemia, hypoalbuminemia, lower-extremity muscle weakness defined as a time of >15 s or inability to complete five sit-to-stand repetitions without using arms. and cognitive impairment is defined as a score of <24 on the Mini-Mental State Examination (which is highly unlikely if the patient is able to correctly recall 3 out of 3 words after a distractive task and may obviate the need for further cognitive testing).	Month 3 and Month 6
Other	Cognitive Function Assessed by the Mini-mental State Examination	A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding, and memory).	Month 3 and Month 6
Other	Quality of Life Assessed by the EuroQol 5-dimension 5-level (EQ-5D-5L)	The EQ-5D-5L is a quality-of-life tool with 5 components designed to detect health utilities: mobility, usual activities, self-care, pain/discomfort, and anxiety/depression. All components are rated on a scale of 1-5 with higher scores indicating worse health status.	Month 3 and Month 6
Other	Nutrition Status Assessed by the Mini-Nutritional Assessment	The Mini Nutritional Assessment (MNA) has recently been designed and validated to provide a single, rapid assessment of nutritional status in elderly patients in outpatient clinics, hospitals, and nursing homes. The MNA test is composed of simple measurements and brief questions that can be completed in about 10 min. The sum of the MNA score distinguishes between elderly patients with 1) adequate nutritional status, MNA > or = 24; 2) protein-calorie malnutrition, MNA < 17; 3) at risk of malnutrition, MNA between 17 and 23.5.	Month 3 and Month 6
Other	Anxiety Assessed by the General Anxiety Disorder-7 (GAD-7)	The Generalised Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day".	Month 3 and Month 6
Other	Depression Assessed by the Geriatric Depression Scale (GDS-15)	The 15-item geriatric depression scale (GDS-15) is a short form of GDS and is used to screen, diagnose, and evaluate depression in elderly individuals.	Month 3 and Month 6
Other	Sleep Assessed by the Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.	Month 3 and Month 6
Other	Functional capacity Assessed by the Duke Activity Status Index (DASI)	The Duke Activity Status Index is a patient-reported estimate of functional capacity, maximal oxygen consumption (VO2 max), and maximum metabolic equivalent of tasks (METs).	Month 3 and Month 6
Other	Economic Analysis Assessed by direct medical costs, direct non-medical costs, and the cost of rehabilitation therapy.	Assess the economic impact of the intervention by comparing medical costs between two groups, inclusive of direct medical costs, direct non-medical costs, and the cost of rehabilitation therapy, relative to its associated changes in health outcomes.	Month 3 and Month 6
Other	Body Mass Index (BMI):weight and height will be combined to report BMI in kg/m^2	Calculate BMI values by measuring the patient's height and weight. Weight should be in kilograms. Height should be in meters)	Month 3 and Month 6
Other	Systolic and Diastolic Blood Pressure Assessed by a medical electronic sphygmomanometer at the outpatient.	The unit of systolic and diastolic blood pressure should be 'mmHg'.	Month 3 and Month 6
Other	Heart Rate Calculated by the number of heartbeats per minute.	The data collector will measure the heart rate of the patient during each outpatient visit.	Month 3 and Month 6
Other	New York Heart Association classification (NYHA) Presented by Level?, Level?, Level ?, Level ?.	Data collectors obtain NYHA classification by reviewing medical records.	Month 3 and Month 6
Other	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.	During the outpatient follow-up, the patient needs to report whether they have had the symptoms and signs in the past week: yes or no. If there are other symptoms, the patient needs to write them down in detail.	Month 3 and Month 6
Other	Left Ventricular Ejection Fraction Assessed by the echocardiogram and presented by the unit of percentage (%)	Data collectors obtain Left Ventricular Ejection Fraction (%) by reviewing medical records.	Month 3 and Month 6
Other	Biomarkers for the cardiac function Assessed by N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) and Cardiac Troponin T (cTnT)	Data collectors obtain NT-proBNP and cTnT by reviewing medical records. The unit of NT-proBNP is 'pg/mL'. The unit of cTnT is 'ug/L'.	Month 3 and Month 6
Other	Biomarkers for renal function Assessed by Estimated Glomerular Filtration Rate (eGFR).	Data collectors obtain eGFR by reviewing medical records. The unit of eGFR is 'ml/min'.	Month 3 and Month 6
Other	Biomarkers for serum lipid levels Assessed by Triglyceride (TG), Cholesterol (CHOL), Low-Density Lipoprotein Cholesterol (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C).	Data collectors obtain TG, CHOL, LDL-C, and HDL-C by reviewing medical records. The unit of these biomarkers is 'mmol/L'.	Month 3 and Month 6
Other	Red Blood Cells (RBC)	Data collectors obtain RBC by reviewing medical records. The unit of RBC is '10^12/L'.	Month 3 and Month 6
Other	Haemoglobin (HGB)	Data collectors obtain HGB by reviewing medical records. The unit of HGB is 'g/L'.	Month 3 and Month 6
Other	White Blood Cells (WBC)	Data collectors obtain WBC by reviewing medical records. The unit of WBC is '10^9/L'.	Month 3 and Month 6
Other	Blood platelets (PLT)	Data collectors obtain PLT by reviewing medical records. The unit of PLT is '10^9/L'.	Month 3 and Month 6
Other	Biomarkers for coagulation function Assessed by Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT).	Data collectors obtain PT and APTT by reviewing medical records. The unit of PT and APTT is 's'.	Month 3 and Month 6
Other	Social support Assessed by the Lubben Social Network Scale-6 (LSNS-6)	The Lubben Social Network Scale-6 (LSNS-6) is a six-item, self-reported scale to assess social isolation in older adults by measuring perceived social support received by family and friends.	Month 3 and Month 6
Primary	Change in 6-minute Walk Distance	Distance walked in 6 minutes	Month 3
Secondary	Change in 6-minute Walk Distance	Distance walked in 6 minutes	Month 6
Secondary	Change in Short Physical Performance Battery (SPPB)	The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function.	Month 3 and Month 6
Secondary	Exercise Adherence Assessed by the Exercise Adherence Rating Scale (EARS)	Evaluated by the Exercise Adherence Rating Scale (EARS)	Month1, Month 3 and Month 6