Dataset Information

Effects of taichi on grade 1 hypertension: A study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Medication is generally recommended to reduce the morbidity and mortality caused by cardiovascular disease in hypertensive patients. However, considering the difficulties and economic factors associated with long-term medication, interest in taichi as an exercise treatment method has increased recently in Korean medical practice. Numerous studies have suggested that taichi can be used to treat various diseases and that is can affect psychosomatic factors such as anxiety. This study aims to evaluate the effect of taichi in reducing blood pressure among grade 1 hypertensive patients. METHODS/DESIGN:In this randomized, active-controlled, assessor-blinded, two parallel-armed trial, 80 grade 1 hypertension patients will be recruited and randomly assigned to the usual care group or to the taichi group (n?=?40 in each group). Subjects who voluntarily sign a study agreement will be educated in managing their own blood pressure by restricting salt intake, losing weight, moderating alcohol consumption, performing exercise, and regulating dietary intake at their first visit. In addition to self-management, the taichi group will perform two 60-min taichi sessions per week for a total of 8?weeks. Blood pressure will be measured as the primary outcome. In addition, body composition, heart rate, and the perceived intensity and difficulty of the exercise will be measured as secondary outcomes. DISCUSSION:This study is a randomized controlled trial of taichi, which is not widely practiced in Korea. It may provide valuable data on the effects of taichi on hypertension, which will inform non-pharmaceutical treatment options for this disorder. TRIAL REGISTRATION:Clinical Research Information Service, KCT0003632. Registered on 18 March 2019.

SUBMITTER: Lee SH

PROVIDER: S-EPMC7020504 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of taichi on grade 1 hypertension: A study protocol for a randomized controlled trial.

Lee Sang-Hyun SH Kim Byung-Jun BJ Park In-Hwa IH Hwang Eui-Hyoung EH Park Eun Ju EJ Jang Insoo I Hwang Man-Suk MS

Trials 20200213 1

<h4>Background</h4>Medication is generally recommended to reduce the morbidity and mortality caused by cardiovascular disease in hypertensive patients. However, considering the difficulties and economic factors associated with long-term medication, interest in taichi as an exercise treatment method has increased recently in Korean medical practice. Numerous studies have suggested that taichi can be used to treat various diseases and that is can affect psychosomatic factors such as anxiety. This ...[more]

PMID: 32054537

Similar Datasets

Project description:BACKGROUND:Insomnia is common in primary care medical practices. Although behavioral treatments for insomnia are safe, efficacious, and recommended in practice guidelines, they are not widely-available, and their effects on comorbid medical conditions remain uncertain. We are conducting a pragmatic clinical trial to test the efficacy of two cognitive behavioral treatments for insomnia (Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi)) versus an enhanced usual care condition (EUC). METHODS/DESIGN:The study is a three-arm, parallel group, randomized controlled trial. Participants include 625 adults with hypertension and insomnia, recruited via electronic health records from primary care practices affiliated with a large academic medical center. After screening and baseline assessments, participants are randomized to treatment. BBTI is delivered individually with a live therapist via web-interface/telehealth sessions, while SHUTi is a self-guided, automated, interactive, web-based form of cognitive behavioral therapy for insomnia. Participants in EUC receive an individualized sleep report, educational resources, and an online educational video. Treatment outcomes are measured at 9 weeks, 6 months, and 12 months. The primary outcome is patient-reported sleep disturbances. Secondary outcomes include other self-reported sleep measures, home blood pressure, body mass index, quality of life, health functioning, healthcare utilization, and side effects. DISCUSSION:This randomized clinical trial compares two efficacious insomnia interventions to EUC, and provides a cost-effective and efficient examination of their similarities and differences. The pragmatic orientation of this trial may impact sleep treatment delivery in real world clinical settings and advance the dissemination and implementation of behavioral sleep interventions. TRIAL REGISTRATION:ClinicalTrials.gov (Identifier: NCT02508129 ; Date Registered: July 21, 2015).

Project description:Blood pressure (BP) is poorly controlled among a large proportion of hypertensive outpatients. Innovative models of care are therefore needed to improve BP control. The Team-Based Care for improving Hypertension management (TBC-HTA) study aims to evaluate the effect of a team-based care (TBC) interprofessional intervention, involving nurses, community pharmacists and physicians, on BP control of hypertensive outpatients compared to usual care in routine clinical practice.The TBC-HTA study is a pragmatic randomized controlled study with a 6-month follow-up which tests a TBC interprofessionnal intervention conducted among uncontrolled treated hypertensive outpatients in two ambulatory clinics and among seven nearby community pharmacies in Lausanne and Geneva, Switzerland. A total of 110 patients are being recruited and randomized to TBC (TBC: N?=?55) or usual care group (UC: N?=?55). Patients allocated to the TBC group receive the TBC intervention conducted by an interprofessional team, involving an ambulatory clinic nurse, a community pharmacist and a physician. A nurse and a community pharmacist meet patients every 6 weeks to measure BP, to assess lifestyle, to estimate medication adherence, and to provide education to the patient about disease, treatment and lifestyle. After each visit, the nurse and pharmacist write a summary report with recommendations related to medication adherence, lifestyle, and changes in therapy. The physician then adjusts antihypertensive therapy accordingly. Patients in the UC group receive usual routine care without sessions with a nurse and a pharmacist. The primary outcome is the difference in daytime ambulatory BP between TBC and UC patients at 6-month of follow-up. Secondary outcomes include patients' and healthcare professionals' satisfaction with the TBC intervention and BP control at 12 months (6 months after the end of the intervention).This ongoing study aims to evaluate the effect of a newly developed team-based care intervention engaging different healthcare professionals on BP control in a primary care setting in Switzerland. The results will inform policymakers on implementable strategies for routine clinical practice.ClinicalTrials.gov registration: NCT02511093 . Retrospectively registered on 28 July 2015.

Project description:BACKGROUND:Hypertension prevalence in young adults has increased and is associated with increased incidence of cerebrovascular and cardiovascular events in middle age. However, there is significant debate regards how to effectively manage young adult hypertension with recommendation to target lifestyle intervention. Surprisingly, no trials have investigated whether lifestyle advice developed for blood pressure control in older adults is effective in these younger populations. METHODS/DESIGN:TEPHRA is an open label, parallel arm, randomised controlled trial in young adults with high normal and elevated blood pressure. The study will compare a supervised physical activity intervention consisting of 16 weeks structured exercise, physical activity self-monitoring and motivational coaching with a control group receiving usual care/minimal intervention. Two hundred young adults aged 18-35 years, including a subgroup of preterm born participants will be recruited through open recruitment and direct invitation. Participants will be randomised in a ratio of 1:1 to either the exercise intervention group or control group. Primary outcome will be ambulatory blood pressure monitoring at 16 weeks with measure of sustained effect at 12 months. Study measures include multimodal cardiovascular assessments; peripheral vascular measures, blood sampling, microvascular assessment, echocardiography, objective physical activity monitoring and a subgroup will complete multi-organ magnetic resonance imaging. DISCUSSION:The results of this trial will deliver a novel, randomised control trial that reports the effect of physical activity intervention on blood pressure integrated with detailed cardiovascular phenotyping in young adults. The results will support the development of future research and expand the evidence-based management of blood pressure in young adult populations. TRIAL REGISTRATION:Clinicaltrials.gov registration number NCT02723552 , registered on 30 March, 2016.

Project description:Although China has a large number of older people living with diabetes and hypertension, the primary care system is underdeveloped and so management of these conditions in community care settings is suboptimal. Studies have shown that the collaborative care model across care settings that address both pharmacology and nonpharmacology interventions can achieve hypertension control for older people with diabetes. Barriers to implementing and evaluating this model of care are widely recognized in low and middle-income countries including China. This study will therefore test the hypothesis that a hypertension management program built on collaboration between hospitals and community health service centers in China can improve blood pressure control in people aged 60 years and older with diabetes as compared to usual care.A cluster randomized controlled trial will randomly allocate 10 wards from four hospitals in Nanchang to either an intervention group (N?=?5) or a usual care group (N?=?5). At least 27 participants will be recruited from each ward and the estimated sample size will be 135 patients in each group. The intervention includes individualized self-care education prior to discharge and 6-month follow-up in community health service centers. Health professionals from both hospitals and community health service centers will be resourced to collaborate on the implementation of the postdischarge interventions that reinforce self-care. The primary outcome is systolic blood pressure at 6-month follow-up adjusted for baseline value. Secondary outcomes are self-care knowledge, treatment adherence, HbA1c and lipid levels, quality of life, the incidence of adverse events and the incidence of unplanned hospital readmission at 6-month follow-up adjusted for baseline value. A multilevel mixed-effect linear regression model will be used to compare the changes in health outcomes between the intervention and usual care groups.This study will determine whether collaborative care among health professionals between hospitals and community health service centers will improve hypertension management for older people with diabetes in the study sites. The program, if effective, will have an immediate application to hypertension management in the healthcare system in China.Australia New Zealand Clinical Trials Registry, ACTRN12617001352392 . Retrospectively registered on 26 September 2017.

Project description:Cervical intraepithelial neoplasia (CIN) is the premalignant condition of cervical cancer. Whereas not all high grade CIN lesions progress to cervical cancer, the natural history and risk of progression of individual lesions remain unpredictable. Therefore, high-grade CIN is currently treated by surgical excision: large loop excision of the transformation zone (LLETZ). This procedure has potential complications, such as acute haemorrhage, prolonged bleeding, infection and preterm birth in subsequent pregnancies. These complications could be prevented by development of a non-invasive treatment modality, such as topical imiquimod treatment. The primary study objective is to investigate the efficacy of topical imiquimod 5% cream for the treatment of high-grade CIN and to develop a biomarker profile to predict clinical response to imiquimod treatment. Secondary study objectives are to assess treatment side-effects, disease recurrence and quality of life during and after different treatment modalities.The study design is a randomized controlled trial. One hundred forty women with a histological diagnosis of high-grade CIN (CIN 2-3) will be randomized into two arms: imiquimod treatment during 16 weeks (experimental arm) or immediate LLETZ (standard care arm). Treatment efficacy will be evaluated by colposcopy with diagnostic biopsies at 20 weeks for the experimental arm. Successful imiquimod treatment is defined as regression to CIN 1 or less, successful LLETZ treatment is defined as PAP 1 after 6 months. Disease recurrence will be evaluated by cytology at 6, 12 and 24 months after treatment. Side-effects will be evaluated using a standardized report form. Quality of life will be evaluated using validated questionnaires at baseline, 20 weeks and 1 year after treatment. Biomarkers, reflecting both host and viral factors in the pathophysiology of CIN, will be tested at baseline with the aim of developing a predictive biomarker profile for the clinical response to imiquimod treatment.Treatment of high-grade CIN lesions with imiquimod in a selected patient population may diminish complications as a result of surgical intervention. More knowledge on treatment efficacy, side effects and long-term recurrence rates after treatment is necessary.EU Clinical Trials Register EU-CTR2013-001260-34 . Registered 18 March 2013. Medical Ethical Committee approval number: NL44336.068.13 (Medical Ethical Committee Maastricht University Hospital, University of Maastricht). Affiliation: Maastricht University Hospital. Registration number ClinicalTrials.gov: NCT02329171.

Dataset Information

Effects of taichi on grade 1 hypertension: A study protocol for a randomized controlled trial.

Publications

Effects of taichi on grade 1 hypertension: A study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure