The effectiveness and safety of Tai Chi for patients with essential hypertension: study protocol for an open-label single-center randomized controlled trial

Yuxi Li, Dongling Zhong, Chao Dong, Lihong Shi, Yaling Zheng, Yongguo Liu, Qiaoqin Li, Hui Zheng, Juan Li, Tianyu Liu, Rongjiang Jin, Yuxi Li, Dongling Zhong, Chao Dong, Lihong Shi, Yaling Zheng, Yongguo Liu, Qiaoqin Li, Hui Zheng, Juan Li, Tianyu Liu, Rongjiang Jin

Abstract

Background: Evidence showed that Tai Chi may have beneficial effects among hypertensive individuals, although the results are not convincing. We aim to conduct a high-quality clinical trial with 24-h BP measurement to provide robust evidence of Tai Chi for essential hypertension.

Methods: This is an open-label single-center randomized controlled trial with 3 parallel arms. We will compare Tai Chi with walking and waiting-list control. We will recruit 234 hypertensive patients with mild to moderate essential hypertension and randomly assign them to 3 different groups. Participants in Tai Chi group will receive a group-format Yang style 24-form Tai Chi exercise program, 3 sessions per week for 12 weeks. The walking group will be asked to walk, 3 sessions per week for 12 weeks. The waiting-list group will not receive any interventions and/or exercise training. The primary outcome is the change in average 24-h systolic blood pressure (SBP) between baseline and 12 weeks after randomization. The secondary outcomes include 24-h Diastolic Blood Pressure (DBP), average SBP and average DBP during the daytime and night-time, blood pressure (BP) variability, SBP load and DBP load, circadian rhythm of BP, and morning BP surge, endothelial functional indicators, home measured BP, quality of life, adverse events and so on.

Discussion: We expect findings of this trial will provide important insight into application of Tai Chi as an effective and acceptable method for hypertensive patients. Successful completion of this proposed study will also contribute to promotion of Tai Chi in the community in the future.

Trial registration: Clinicaltrials.gov registry: https://ichgcp.net/clinical-trials-registry/NCT04267471 , date: February 12, 2020.

Keywords: Hypertension; Open label; Protocol; Randomized controlled trials; Tai Chi.

Conflict of interest statement

The authors declare that they have no competing interests. This study protocol has undergone peer-review by the funding body.

Figures

Fig. 1
Fig. 1
Flow diagram of study design

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