Effectiveness of Cardiac Rehabilitation With Remote Connection Device for Patients After Surgery for Acquired Heart Valve Disease
Phase: NA
Conditions: Valvular Diseases
Sponsor: Hanoi Medical University

Study protocol 
Certificate of Approval No 1880/GCN – HMUIBR dated 
14/04/2025 
Research proposal version 1 date 16/11/2024 
 

Project title: Effectiveness of cardiac rehabilitation with remote connection device 
for patients after surgery for acquired heart valve disease. 
1. Introduction: Valvular heart disease (VHD) is a major cause of cardiovascular 
mortality worldwide. With the global trend of population aging and advancements 
in diagnostic imaging and surgical techniques, the prevalence of VHD has been 
steadily increasing. Valve surgery, including valve repair or replacement, has 
significantly improved patient outcomes by enhancing quality of life and reducing 
mortality. However, a considerable proportion of patients continue to face 
postoperative complications, such as prolonged mechanical ventilation, hospital-
acquired pneumonia, and sepsis. 
Cardiac rehabilitation (CR) has emerged as a vital component of post-surgical care, 
proven to enhance physical function, shorten hospital stays, reduce readmission 
rates, and lower mortality. In many high-income countries, structured CR programs 
are well-integrated into standard care and supported by health insurance policies. 
In Japan, for instance, patients are eligible for up to 150 days of insurance-covered 
CR services. 
In Vietnam, while inpatient CR has gained attention in recent years at major 
hospitals, long-term outpatient or home-based CR remains limited. Moreover, 
patients do not receive insurance coverage for post-discharge CR services, creating 
barriers such as travel difficulties, time constraints, and financial burden. These 
challenges significantly hinder access to continuous rehabilitation, which is 
essential for optimal recovery after valve surgery. 
Given the development of digital health technologies, remote-connected cardiac 
rehabilitation (tele-rehabilitation) has become an emerging solution to support 
patient recovery at home. International studies have demonstrated the 
effectiveness of tele-rehabilitation in improving outcomes and increasing 
accessibility. However, no domestic research has been conducted to evaluate the 
effectiveness of tele-rehabilitation for patients in the recovery phase after acquired 
valvular heart surgery in Vietnam. 

Recognizing the advantages and suitability of remote rehabilitation for 
cardiovascular 
patients 
in 
Vietnam, 
we 
propose 
this 
study: 
" Effectiveness of cardiac rehabilitation with remote connection device for 
patients after surgery for acquired heart valve disease." 
Study Objectives: 
1. To evaluate the outcomes of cardiac rehabilitation using remote support 
device for patients after surgery for acquired valvular heart disease at Hanoi 
Medical University Hospital. 
2. To analyze factors associated with the outcomes of cardiac rehabilitation 
using remote support device in this patient population. 
2. Subjects and Methods 
2.1 Study Subjects 
2.1.1 Inclusion Criteria 
• Patients undergoing first-time surgery for acquired valvular heart disease, 
including valve repair or replacement involving the aortic, mitral, tricuspid, 
pulmonary valve, or any combination thereof. 
• Aged 18 to 70 years. 
• Willingness to participate and provide informed consent. 
2.1.2 Exclusion Criteria 
• Contraindications to participation in cardiac rehabilitation. 
2.2 Sample Size 
Sample size was calculated based on the comparison of mean differences in Six-
minute Walk Test result between the intervention and control groups, using a two-
sided test with a significance level (α) of 0.05 and a power (1-β) of 0.80. The final 
sample size was adjusted to account for an anticipated dropout rate. (Detailed 
calculation is available in the appendix.) 
2.3 Study Design 

This was a prospective, randomized controlled trial conducted at the Cardiac 
Center and Rehabilitation Department – Hanoi Medical University Hospital, Hanoi 
Capital 
2.4 Randomization 
Patients who completed the inpatient phase I and phase IIa cardiac rehabilitation 
program and met the inclusion criteria were randomly assigned to either the 
intervention or control group using a simple randomization method (rolling a die). 
Patients rolling an even number were allocated to the intervention group; odd 
numbers were assigned to the control group. Randomization was conducted by a 
researcher not involved in outcome assessment. 
2.5 Intervention 
Both groups received standard inpatient cardiac rehabilitation (Phase I and Phase 
IIa) during hospitalization. After discharge: 
• Control group: Received routine outpatient follow-up and general advice for 
home-based physical activity. 
• Intervention group: Participated in a structured, supervised home-based 
cardiac rehabilitation program supported by the Open TeleRehab software. 
Details of the Intervention Program: 
• Duration: 4 weeks after hospital discharge. 
• Frequency: 3 sessions of aerobic exercise and lower limbs resistant exercise 
per week at home. 
• Modality: Walking or cycling, with progressive intensity guided by heart rate 
reserve (HRR), based on the Karvonen formula and Cardiopulmonary Exercise 
Testing result; lower limbs resistant exercise with body weight, plastic band, 
dumbbells. 
• Monitoring: Patients were provided with pulse oximeters and blood pressure 
monitors. Exercise sessions were supervised remotely via the Open 
TeleRehab application, which allowed real-time data collection and feedback. 

• Follow-up: Weekly online meetings were held between patients and the 
rehabilitation team to assess adherence, answer questions, and adjust 
exercise plans if necessary. 
2.6 Outcome Measures 
Primary Outcome: 
• Peak oxygen uptake (VO₂ max) measured via cardiopulmonary exercise 
testing (CPET) at baseline (pre-surgery), pre-discharge, and 1 month post-
discharge. 
Secondary Outcomes: 
• Functional capacity assessed by: 
o Six-minute walk test (6MWT) 
o Two-minute step test (TMST) 
• Pulmonary function: inspiratory lung capacity using spriro-ball spirometer. 
• Heart rate recovery (HRR) post-CPET. 
Assessment Time Points: 
Time Point 
Assessment Parameters 
T1: Pre-operative 
TMST, 6MWT, spriro-ball spirometer 
T2: Post-operative, Day 1 Phase I Inspiratory lung capacity (spriro-ball spirometer) 
T3: Post-operative, Day 7 
CPET, 6MWT, TMST, spriro-ball spirometer 
T4: Pre-discharge 
CPET, TMST, 6MWT, spriro-ball spirometer 
T5: 1 month post-discharge 
CPET, TMST, 6MWT 
2.7 Data Analysis 
Data were analyzed using SPSS version 26. Continuous variables were tested for 
normality using the Shapiro-Wilk test. Descriptive statistics are presented as mean 

± standard deviation or median (IQR) as appropriate. Between-group comparisons 
were performed using the independent t-test or Mann-Whitney U test. Paired t-
tests or Wilcoxon signed-rank tests were used for within-group comparisons. 
Categorical variables were compared using the chi-square or Fisher's exact test. A 
p-value < 0.05 was considered statistically significant.