Table 2 All relevant items in the World Health Organization’s trial registration data set
From: Effects of taichi on grade 1 hypertension: A study protocol for a randomized controlled trial
Data category | Information |
|---|---|
Primary registry and trial identifying number | Clinical Research Information Service, KCT0003632 |
Date of registration in primary registry | 18 March 2019 |
Secondary identifying numbers | Not applicable |
Source(s) of monetary or material support | Traditional Korea Medicine R&D program of Korea Health Industry Development Institute |
Primary sponsor | Woosuk University |
Secondary sponsor(s) | Not applicable |
Contact for public queries | Man-Suk Hwang, + 82–55–360-5970, hwangmansuk@pusan.ac.kr |
Contact for scientific queries | Man-Suk Hwang, Department of Rehabilitation Medicine of Korean Medicine, Spine and Joint Center, Pusan National University Korean Medicine Hospital, 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongnam 50612, Republic of Korea. |
Public title | Effects of taichi on grade 1 hypertension: A study protocol for a randomized controlled trial |
Scientific title | The Effects of Taichi on Grade 1 Hypertension: Randomized controlled trial |
Countries of recruitment | Republic of Korea |
Health condition(s) or problem(s) studied | Hypertension |
Intervention(s) | Taichi |
Key inclusion and exclusion criteria | Inclusion Criteria o Patients must have been diagnosed with grade 1 hypertension during a health checkup or at the hospital, have SBP of 140 to 159 mmHg, or have DBP of 90 to 99 mmHg. o Patients who understand the study procedures and are able to follow the advice given o Patients must sign the study agreement and voluntarily agree to participate in the study Exclusion Criteria o Patients who have participated in another trial within a month before this study. o Patients whose high blood pressure is deemed by a doctor as too difficult to treat with exercise because of conditions such as severe pain or joint deformation. o Patients who are unable to communicate properly, for example due to dementia or mild cognitive impairment. o Patients who are pregnant. o Patients who should not be included in this study based on the investigator’s judgment. |
Study type | Type of Study: Interventional Method of allocation: Randomized Masking: Outcome assessor blinding Assignment: Two-parallel armed, active controlled |
Date of first enrollment | 17 April 2019 |
Target sample size | 1. Number of patients that the trial plans to enroll in total: 80 2. Number of patients that the trial has enrolled: 19 |
Recruitment status | Recruiting |
Primary outcome(s) | Blood pressure, which will be measured at baseline, prior to each hospital visit, and during the follow-up visit |
Key secondary outcomes | Body composition, which will be measured at baseline, week 8, and at the follow-up visit Heart rate, which will be measured at baseline, prior to each visit, and during the follow-up visit Intensity and difficulty of the exercises, which will be assessed once, at the end of the exercise training. |
Ethics Review | 1. Status: Approved 2. Date of approval: 16 January 2019 3. Name and contact details of Ethics committee: Pusan National University Korean Medicine Hospital IRB (approval number 2018014), 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongnam 50612, Republic of Korea, + 82–55–360-5902 |
Completion date | 15 January 2020 |
Summary results | Not applicable: protocol |
Individual patient data sharing statement | 1. Plan to share individual patient data: Decided 2. Plan description: The datasets used or analyzed during the study can be requested from the corresponding author |