Effectiveness of Remotely Monitored Home-Based Baduanjin using Wearable Devices for Elder Patients after coronary revascularization: A Study Protocol for a Randomized Controlled Trial

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Post-coronary revascularization (PCI or CABG) with cardiopulmonary dysfunction (n=398). Intervention: Remotely monitored home-based Baduanjin exercise using wearable devices combined with conventional secondary prevention education vs. Conventional secondary prevention education alone. Primary outcome: Change in peak oxygen uptake (VO2 peak) obtained from cardiopulmonary exercise testing (CPET) at week 12 compared with baseline.

Tianli Li; Hong Jiang; Zhizhou Lin; Xuelin Li; Xiang Xiao; 梦如 刘; Lin Zhao; Tong Gao; Peng Yang

doi:10.21203/rs.3.rs-6538568/v1

October 23, 2026Open Access

Effectiveness of Remotely Monitored Home-Based Baduanjin using Wearable Devices for Elder Patients after coronary revascularization: A Study Protocol for a Randomized Controlled Trial

View Full Paper

Ask AI

Bookmark

Share

Key result

RCT evaluates home-based Baduanjin training for improving peak VO2 after coronary revascularization.

n=398

Why the study?

Many CAD patients experience cardiopulmonary dysfunction after PCI or CABG, and evidence regarding the effectiveness and safety of remotely monitored home-based Baduanjin exercise for these patients is limited.

Does remotely monitored home-based Baduanjin exercise using wearable devices combined with conventional secondary prevention education improve peak oxygen uptake (VO2 peak) at 12 weeks compared to conventional secondary prevention education alone in elder patients with cardiopulmonary dysfunction after coronary revascularization?

Key Points

To evaluate the effectiveness and safety of remotely monitored home-based Baduanjin exercise using wearable devices for older patients experiencing cardiopulmonary dysfunction after coronary revascularization.
Participants are randomized 1:1 to either 12 weeks of remotely monitored home-based Baduanjin plus conventional secondary prevention education or conventional education alone.
The planned primary endpoint is change in peak oxygen uptake (VO2 peak) obtained from cardiopulmonary exercise testing at week 12 relative to baseline.
Secondary endpoints include 6-minute walk distance, Seattle Angina Questionnaire scores, left ventricular ejection fraction, EQ-5D quality-of-life indices, and composite cardiovascular events.
Patient recruitment opened September 1, 2024, with completion anticipated by late April 2026; formal intervention outcomes are not yet available.

Study Design

Type

RCT (n=398)

Blinding

Assessor-blinded (outcome assessors and statisticians blinded)

Randomization

1:1 ratio using a web-based central randomization system

Multicenter

Yes

Structured PICO

Does remotely monitored home-based Baduanjin exercise using wearable devices combined with conventional secondary prevention education improve peak oxygen uptake (VO2 peak) at 12 weeks compared to conventional secondary prevention education alone in elder patients with cardiopulmonary dysfunction after coronary revascularization?

P

Population

398 planned older adults (aged 60-80 years) in China with coronary artery disease and NYHA class I-II cardiopulmonary dysfunction within 2-4 weeks after PCI or CABG, followed for 12 weeks.

I

Intervention

Remotely monitored home-based Baduanjin training (at least 30 minutes per day, 3-5 days per week for 12 weeks / 3 months) using wearable devices (DEG-A-P for continuous ECG, exercise intensity, and breathing signals) and electronic blood pressure tester (A223), managed via the 'Internet Plus' remote platform with weekly feedback, combined with conventional secondary prevention education of CAD (medication adherence, lifestyle change, and risk factor control).

C

Comparator

Conventional secondary prevention education of CAD alone (medication adherence education, lifestyle change education, and risk factor control education, without exercise style advice or any additional cardiac rehabilitation interventions) for 12 weeks. Neither group receives in-hospital cardiac rehabilitation.

O

Outcome

Change in peak oxygen uptake (VO2 peak) obtained from cardiopulmonary exercise testing (CPET) at week 12 compared with baseline.surrogate

Limitations

Patients and therapists cannot be blinded due to the nature of the Baduanjin intervention, potentially introducing subjective bias
Relatively short follow-up period of 12 weeks limits assessment of long-term recovery and cardiovascular events
Patients and the therapist cannot be blinded during the intervention due to the nature of the Baduanjin intervention, which may introduce subjective bias.
The follow-up period is relatively short (12 weeks), limiting the assessment of the long-term impact on recovery and cardiovascular events.

Implication

This study protocol outlines a multicenter randomized controlled trial designed to evaluate whether remotely monitored home-based Baduanjin exercise using wearable devices can improve cardiopulmonary function (VO2 peak) and clinical outcomes in elder patients following coronary revascularization.

Abstract

Introduction: Coronary artery disease(CAD) is a prevalent cardiovascular disorder, and coronary revascularization, including percutaneous coronary intervention(PCI) and coronary artery bypass grafting(CABG), is a common treatment. However, many patients still suffer from cardiopulmonary dysfunction after the surgery. Baduanjin, a traditional Chinese exercise, may have potential benefits for these patients, but evidence is limited. This trial aims to determine the effectiveness and safety of remotely monitored home-based Baduanjin for post-coronary revascularization patients with cardiopulmonary dysfunction. Methods and analysis: This is a multicenter, assessor-blinded, two-armed randomized controlled trial. Three hundred and ninety-eight patients will be recruited from China-Japan Friendship Hospital, Fuwai Hospital, Xuanwu Hospital, and Guang'anmen Hospital, and randomly assigned to two groups (group A or group B) in a 1:1 ratio. Patients in group A will receive remotely monitored home-based Baduanjin training combined with conventional secondary prevention education of CHD, while patients in group B will receive conventional secondary prevention education alone for 12 weeks. The primary outcome will be the peak oxygen uptake (VO 2 peak) obtained from cardiopulmonary exercise testing (CPET) at week 12 compared with baseline. Secondary outcomes will include 6-minute walk distance (6MWD), Seattle Angina Questionnaire (SAQ), health-related quality of life measured by EQ-5D-VAS and EQ-5D-5L, left ventricular ejection fraction (LVEF), anxiety and depression scales (GAD-7 and PHQ-9), Montreal Cognitive Assessment (MoCA), composite cardiovascular events (including re-revascularization, AMI, death, stroke, heart failure rehospitalization), and other relevant indicators at weeks 0, 4, 8, and 12. Safety indicators will be monitored throughout the trial. Ethics and dissemination: This study has been approved by the clinical research ethics committee of China-Japan Friendship Hospital (No.2024-KY-031), the results of this study will be disseminated via peer-reviewed publications or conference presentations. Trial registration number: Chinese Clinical Trial Registry (No. ChiCTR2400088668, https://www.chictr.org.cn/showproj.html?proj=232409) registered on 23 August 2024.

Discussion

No takes yet. Share an insight, caveat, or question.

Cite This Study

Li et al. (2026) conducted an RCT in Post-coronary revascularization (PCI or CABG) with cardiopulmonary dysfunction (n=398). Remotely monitored home-based Baduanjin exercise using wearable devices combined with conventional secondary prevention education vs. Conventional secondary prevention education alone was evaluated on Change in peak oxygen uptake (VO2 peak) obtained from cardiopulmonary exercise testing (CPET) at week 12 compared with baseline. Remotely monitored home-based Baduanjin training is being evaluated in a 398-patient RCT protocol to assess 12-week change in peak VO2 after coronary revascularization; no results are reported yet.

synapsesocial.com/papers/6ae28f3acbadf70daf6c4422 https://doi.org/10.21203/rs.3.rs-6538568/v1

View Full Paper

Ask AI

Bookmark

Share

Effectiveness of Remotely Monitored Home-Based Baduanjin using Wearable Devices for Elder Patients after coronary revascularization: A Study Protocol for a Randomized Controlled Trial

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

Effectiveness of Remotely Monitored Home-Based Baduanjin using Wearable Devices for Elder Patients after coronary revascularization: A Study Protocol for a Randomized Controlled Trial

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

Keep reading

Keep reading