Dataset Information

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

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://clinicaltrials.gov/ct2/show/NCT04267471 , date: February 12, 2020.

SUBMITTER: Li Y

PROVIDER: S-EPMC7792191 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Li Yuxi Y Zhong Dongling D Dong Chao C Shi Lihong L Zheng Yaling Y Liu Yongguo Y Li Qiaoqin Q Zheng Hui H Li Juan J Liu Tianyu T Jin Rongjiang R

BMC complementary medicine and therapies 20210107 1

<h4>Background</h4>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.<h4>Methods</h4>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 m ...[more]

PMID: 33413354

Similar Datasets

Project description:INTRODUCTION:Preliminary evidence from clinical observations suggests that Tai Chi exercise may offer potential benefits for patients with chronic coronary syndrom (CCS). However, the advantages for CCS patients to practice Tai Chi exercise as rehabilitation have not been rigorously tested and there is a lack of consensus on its benefits. This study aims to develop an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for CCS patients and to assess the efficacy, safety and acceptability of the programme. METHODS AND ANALYSIS:We propose to conduct a multicentre randomised controlled clinical trial comprising of 150 participants with CCS. The patients will be randomly assigned in a 1:1 ratio into two groups. The intervention group will participate in a supervised TCCRP held three times a week for 3 months. The control group will receive supervised conventional exercise rehabilitation held three times a week for 3 months. The primary and secondary outcomes will be assessed at baseline, 1?month, 3 months after intervention and after an additional 3-month follow-up period. Primary outcome measures will include a score of 36-Item Short Form Survey and Chinese Perceived Stress Scale. The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination. Other measures also include Seattle Angina Scale, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Berg Balance Scale. All adverse events will be recorded and analysed. ETHICS AND DISSEMINATION:This study conforms to the principles of the Declaration of Helsinki and relevant ethical guidelines. Ethical approval has been obtained from the Ethics Committee of Chinese People's Libration Army General Hospital (approval number: S2019-060-02). Findings from this study will be published and presented at conferences for widespread dissemination of the results. TRIAL REGISTRATION NUMBER:NCT03936504.

Project description:ObjectiveThe main treatment for essential hypertension at this stage is pharmacotherapy. Long-term pharmacotherapy is costly with some side effects. Tai Chi, a bright star in traditional Chinese arts, relaxes both mind and body and has been shown to relax blood vessels and lower blood pressure. This study aimed to systematically review the therapeutic effectiveness of the Tai Chi exercise cycle on blood pressure and cardiovascular risk factors of patients with essential hypertension.MethodsSearching CNKI, VIP, CBM, PubMed, EBSCO, Embase, Cochrane Library, and Web of Science to collect randomized controlled trials about Tai Chi exercise in the treatment of patients with essential hypertension according to the inclusion and exclusion criteria. The search time ranged from the date of database construction to December 2022. The Cochrane risk-of-bias tool was used to evaluate the included trials. The meta-analysis was performed with RevMan5.3 and Stata12.0 software.ResultsAccording to the meta-analysis, compared with the controls, Tai Chi exercise with a cycle of more than 12 weeks may be better for the reduction of systolic blood pressure (SBP) [MD = -11.72, 95% CI (-15.52, -7.91)] and diastolic blood pressure (DBP) [MD = -4.68, 95% CI (-7.23, -2.12)], as well as increasing the content of nitric oxide (NO) [MD = 0.99, 95% CI (0.69, 1.28)]. The blood lipid metabolism ability may also be improved after more than 12 weeks of Tai Chi exercise, total cholesterol (TC) [SMD = -0.68, 95% CI (-0.89, -0.46), triglyceride (TG) [SMD = -0.84, 95% CI (-1.25, -0.43)], low-density lipoprotein cholesterol (LDL-C) [SMD = -1.58, 95% CI (-2.29, -0.86)]. However, the improvement of high-density lipoprotein cholesterol (HDL-C) [SMD = 0.54, 95% CI (0.28, 0.79)] was better with a less than 12 weeks exercise cycle. A subgroup analysis for exercise frequency and time showed that the exercise frequency should preferably be more than or equal to 5 times per week for patients with hypertension, and for patients with hypertension plus hyperlipidemia, the exercise frequency less than 5 times per week with exercise time less than 60 min each day may be more beneficial.ConclusionThe meta-analysis indicated that a more than 12 weeks Tai Chi exercise cycle with less than 60 min each time and more than 5 times per week may be more beneficial in blood pressure reduction, NO level increasing and blood lipid metabolism improving in the comparison with the other exercise cycles. For patients with hypertension plus hyperlipidemia, exercise frequency of less than 5 times per week may be better.Systematic review registration[http://www.crd.york.ac.uk/prospero], identifier [CRD42022352035].

Project description:BackgroundThis overview summarizes the best available systematic review (SR) evidence on the health effects of Tai Chi.MethodsNine databases (PubMed, Cochrane Library, EMBASE, Medline, Web of Science, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), Sino-Med, and Wanfang Database) were searched for SRs of controlled clinical trials of Tai Chi interventions published between Jan 2010 and Dec 2020 in any language. Effect estimates were extracted from the most recent, comprehensive, highest-quality SR for each population, condition, and outcome. SR quality was appraised with AMSTAR 2 and overall certainty of effect estimates with the GRADE method.ResultsOf the 210 included SRs, 193 only included randomized controlled trials, one only included non-randomized studies of interventions, and 16 included both. Common conditions were neurological (18.6%), falls/balance (14.7%), cardiovascular (14.7%), musculoskeletal (11.0%), cancer (7.1%), and diabetes mellitus (6.7%). Except for stroke, no evidence for disease prevention was found; however, multiple proxy-outcomes/risks factors were evaluated. One hundred and fourteen effect estimates were extracted from 37 SRs (2 high, 6 moderate, 18 low, and 11 critically low quality), representing 59,306 adults. Compared to active and/or inactive controls, 66 of the 114 effect estimates reported clinically important benefits from Tai Chi, 53 reported an equivalent or marginal benefit, and 6 an equivalent risk of adverse events. Eight of the 114 effect estimates (7.0%) were rated as high, 43 (37.7%) moderate, 36 (31.6%) low, and 27 (23.7%) very low certainty evidence due to concerns with risk of bias (92/114, 80.7%), imprecision (43/114, 37.7%), inconsistency (37/114, 32.5%), and publication bias (3/114, 2.6%). SR quality was often limited by the search strategies, language bias, inadequate consideration of clinical, methodological, and statistical heterogeneity, poor reporting standards, and/or no registered SR protocol.ConclusionsThe findings suggest Tai Chi has multidimensional effects, including physical, psychological and quality of life benefits for a wide range of conditions, as well as multimorbidity. Clinically important benefits were most consistently reported for Parkinson's disease, falls risk, knee osteoarthritis, low back pain, cerebrovascular, and cardiovascular diseases including hypertension. For most conditions, higher-quality SRs with rigorous primary studies are required.Systematic review registrationPROSPERO CRD42021225708.

Project description:BACKGROUND:Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Current pharmacological therapies may cause serious adverse effects, are expensive, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise (a recommended component of the current standard of care) in a large fibromyalgia population. This article describes the design and conduct of this trial. METHODS/DESIGN:A single-center, 52-week, randomized controlled trial of Tai Chi versus aerobic exercise is being conducted at an urban tertiary medical center in Boston, Massachusetts. We plan to recruit 216 patients with fibromyalgia. The study population consists of adults ?21 years of age with fibromyalgia who meet American College of Rheumatology 1990 and 2010 diagnostic criteria. Participants are randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi held once or twice per week, or a supervised aerobic exercise control held twice per week for 24 weeks. The primary outcome is the change in Revised Fibromyalgia Impact Questionnaire total score from baseline to 24 weeks. Secondary outcomes include measures of widespread pain, symptom severity, functional performance, balance, muscle strength and power, psychological functioning, sleep quality, self-efficacy, durability effects, and health-related quality of life at 12, 24, and 52 week follow-up. DISCUSSION:This study is the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise in a large fibromyalgia population with long-term follow up. We present here a robust and well-designed trial to determine the optimal frequency and duration of a supervised Tai Chi intervention with regard to short- and long-term effectiveness. The trial also explores multiple outcomes to elucidate the potential mechanisms of Tai Chi and aerobic exercise and the generalizability of these interventions across instructors. Results of this study are expected to have important public health implications for patients with a major disabling disease that incurs substantial health burdens and economic costs. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT01420640 , registered 18 August 2011.

Project description:BackgroundFew remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis.ObjectiveTo compare Tai Chi with standard physical therapy for patients with knee osteoarthritis.DesignRandomized, 52-week, single-blind comparative effectiveness trial. (ClinicalTrials.gov: NCT01258985).SettingAn urban tertiary care academic hospital.Patients204 participants with symptomatic knee osteoarthritis (mean age, 60 years; 70% women; 53% white).InterventionTai Chi (2 times per week for 12 weeks) or standard physical therapy (2 times per week for 6 weeks, followed by 6 weeks of monitored home exercise).MeasurementsThe primary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 weeks. Secondary outcomes included physical function, depression, medication use, and quality of life.ResultsAt 12 weeks, the WOMAC score was substantially reduced in both groups (Tai Chi, 167 points [95% CI, 145 to 190 points]; physical therapy, 143 points [CI, 119 to 167 points]). The between-group difference was not significant (24 points [CI, -10 to 58 points]). Both groups also showed similar clinically significant improvement in most secondary outcomes, and the benefits were maintained up to 52 weeks. Of note, the Tai Chi group had significantly greater improvements in depression and the physical component of quality of life. The benefit of Tai Chi was consistent across instructors. No serious adverse events occurred.LimitationPatients were aware of their treatment group assignment, and the generalizability of the findings to other settings remains undetermined.ConclusionTai Chi produced beneficial effects similar to those of a standard course of physical therapy in the treatment of knee osteoarthritis.Primary funding sourceNational Center for Complementary and Integrative Health of the National Institutes of Health.

Project description:OBJECTIVES:To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. DESIGN:Prospective, randomized, 52 week, single blind comparative effectiveness trial. SETTING:Urban tertiary care academic hospital in the United States between March 2012 and September 2016. PARTICIPANTS:226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. INTERVENTIONS:Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. MAIN OUTCOME MEASURES:The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient's global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. RESULTS:FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient's global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with the same intensity and duration (24 weeks, twice weekly) had greater benefit (between group difference in FIQR scores=16.2 points, 8.7 to 23.6, P<0.001). The groups who received tai chi for 24 weeks showed greater improvements than those who received it for 12 weeks (difference in FIQR scores=9.6 points, 2.6 to 16.6, P=0.007). There was no significant increase in benefit for groups who received tai chi twice weekly compared with once weekly. Participants attended the tai chi training sessions more often than participants attended aerobic exercise. The effects of tai chi were consistent across all instructors. No serious adverse events related to the interventions were reported. CONCLUSION:Tai chi mind-body treatment results in similar or greater improvement in symptoms than aerobic exercise, the current most commonly prescribed non-drug treatment, for a variety of outcomes for patients with fibromyalgia. Longer duration of tai chi showed greater improvement. This mind-body approach may be considered a therapeutic option in the multidisciplinary management of fibromyalgia. TRIAL REGISTRATION:ClinicalTrials.gov NCT01420640.

Project description:BackgroundFalls are a public health issue for the older adult population and more so for people with dementia (PWD). Compared with their cognitively intact peers, PWD are at higher risk of falls and injurious falls. This randomised controlled trial aims to test the clinical and cost effectiveness of Tai Chi to improve postural balance among community-dwelling PWD and to assess the feasibility of conducting a larger definitive trial to reduce the incidence of falls among PWD.MethodsA 3-centre parallel group randomised controlled trial with embedded process evaluation. One hundred and fifty community-dwelling dyads of a person with dementia and their informal carer will be recruited and assessed at baseline and at six-month follow-up. Dyads will be randomised in a 1:1 ratio to either usual care or usual care plus a Tai Chi intervention for 20 weeks. The Tai Chi intervention will consist of weekly classes (45 min' Tai Chi plus up to 45 min for informal discussion, with up to 10 dyads per class) and home-based exercises (20 min per day to be facilitated by the carer). Home practice of Tai Chi will be supported by the use of behaviour change techniques with the Tai Chi instructor at a home visit in week 3-4 of the intervention (action planning, coping planning, self-monitoring, and alarm clock reminder) and at the end of each class (feedback on home practice). The primary outcome is dynamic balance measured using the Timed Up and Go test, coinciding with the end of the 20-week intervention phase for participants in the Tai Chi arm. Secondary outcomes for PWD include functional balance, static balance, fear of falling, global cognitive functioning, visual-spatial cognitive functioning, quality of life, and falls. Secondary outcomes for carers include dynamic balance, static balance, quality of life, costs, and carer burden.DiscussionThis trial is the first in the UK to test the effectiveness of Tai Chi to improve balance among PWD. The trial will inform a future study that will be the first in the world to use Tai Chi in a trial to prevent falls among PWD.Trial registrationNCT02864056 .

Dataset Information

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

Background

Methods

Discussion

Trial registration

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets