Zhongshan Hospital, Fudan University
Shanghai, Shanghaio, 200032, China
NCT Number: NCT05989594
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.
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Notify Me60 year–89 year
All sexes
Interventional
Not applicable
Shanghai, Shanghaio, 200032, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Discharge preparation, scheduled onsite follow-ups, telephone follow-ups
Time frame: Month 3
Distance walked in 6 minutes
Time frame: Month 6
Distance walked in 6 minutes
Time frame: 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.
Time frame: Month1, Month 3 and Month 6
Evaluated by the Exercise Adherence Rating Scale (EARS)
Time frame: Month 3 and Month 6
The combined number of all-cause rehospitalizations and death 3 and 6 months after discharge.
Time frame: Month 3 and Month 6
Handgrip strength is measured in kilograms by a handgrip dynamometer.
Time frame: Month 3 and Month 6
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.
Time frame: Month 3 and Month 6
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).
Time frame: Month 3 and Month 6
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).
Time frame: Month 3 and Month 6
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.
Time frame: Month 3 and Month 6
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.
Time frame: Month 3 and Month 6
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".
Time frame: Month 3 and Month 6
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.
Time frame: Month 3 and Month 6
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.
Time frame: Month 3 and Month 6
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).
Time frame: Month 3 and Month 6
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.
Time frame: Month 3 and Month 6
Calculate BMI values by measuring the patient's height and weight. Weight should be in kilograms. Height should be in meters)
Time frame: Month 3 and Month 6
The unit of systolic and diastolic blood pressure should be 'mmHg'.
Time frame: Month 3 and Month 6
The data collector will measure the heart rate of the patient during each outpatient visit.
Time frame: Month 3 and Month 6
Data collectors obtain NYHA classification by reviewing medical records.
Time frame: Month 3 and Month 6
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.
Time frame: Month 3 and Month 6
Data collectors obtain Left Ventricular Ejection Fraction (%) by reviewing medical records.
Time frame: Month 3 and Month 6
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'.
Time frame: Month 3 and Month 6
Data collectors obtain eGFR by reviewing medical records. The unit of eGFR is 'ml/min'.
Time frame: Month 3 and Month 6
Data collectors obtain TG, CHOL, LDL-C, and HDL-C by reviewing medical records. The unit of these biomarkers is 'mmol/L'.
Time frame: Month 3 and Month 6
Data collectors obtain RBC by reviewing medical records. The unit of RBC is '10^12/L'.
Time frame: Month 3 and Month 6
Data collectors obtain HGB by reviewing medical records. The unit of HGB is 'g/L'.
Time frame: Month 3 and Month 6
Data collectors obtain WBC by reviewing medical records. The unit of WBC is '10^9/L'.
Time frame: Month 3 and Month 6
Data collectors obtain PLT by reviewing medical records. The unit of PLT is '10^9/L'.
Time frame: Month 3 and Month 6
Data collectors obtain PT and APTT by reviewing medical records. The unit of PT and APTT is 's'.
Time frame: Month 3 and Month 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.
Shanghai Zhongshan Hospital
Other
A Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing Transcatheter Aortic Valve Replacement (REHAB-TAVR): a Randomized Clinical Trial
Acronym: REHAB-TAVR
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