scholarly journals Effects of Baduanjin on Essential Hypertension: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Yuanyuan Guan ◽  
Yang Hao ◽  
Yun Guan ◽  
Dongjun Wang ◽  
Xuan Sun ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Essential Hypertension ◽  
Salt Intake ◽  
Controlled Trial ◽  
Trial Registration ◽  
Care Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Incidence And Mortality ◽  
The Impact

Abstract Background: Clinical treatment of hypertension recommends the use of drugs to reduce the incidence and mortality of cardiovascular diseases in hypertensive patients. However, the side effects of long-term medication and economic pressure have increased the medical community's interest in Baduanjin as a method of exercise therapy. Clinical studies have shown that Baduanjin can be used to treat various diseases, and it can also regulate physical and mental factors such as tension and anxiety. This study aims to evaluate the antihypertensive effect of Baduanjin on patients with essential hypertension. Methods/design: In this study, 92 patients with essential hypertension were randomly divided into the Baduanjin group and the routine care group, using a randomized, active control, evaluator blind method, and two parallel control methods, with 46 cases in each group, signed informed Subjects with the consent form will manage their blood pressure by limiting salt intake, losing weight, drinking moderately, exercising, and adjusting dietary intake during the first visit. In addition to self-management, the Baduanjin group will also conduct 30-minute Baduanjin training three times a week for a total of 8 weeks. The main result is the measurement of blood pressure. In addition, body composition will be measured as a secondary result.Discussion: This study is a randomized controlled Baduanjin trial and is not currently widely used. It may provide valuable data on the impact of Baduanjin on essential hypertension, which will inform non-drug treatment options for this disease.Trial registration: Chinese Clinical Trial Registration Center, ChiCTR200003570. Register on August 16, 2020.

scholarly journals The Effects of Tai Chi on Grade 1 Hypertension: A Study Protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Sang Hyun Lee ◽  
Byung-Jun Kim ◽  
In-Hwa Park ◽  
Eui-Hyoung Hwang ◽  
Eun Ju Park ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Tai Chi ◽  
Salt Intake ◽  
Controlled Trial ◽  
Treatment Options ◽  
Treatment Method ◽  
Care Group ◽  
Randomized Controlled

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 tai chi as an exercise treatment method has been recently increasing in Korean medical practice. Numerous studies have suggested that tai chi can be used to treat various diseases and affect psychosomatic factors such as anxiety. This study aims to evaluate the effect of tai chi in reducing blood pressure among grade 1 hypertensive patients.Methods 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 tai chi group (n = 40 in each group). Subjects who voluntarily signed a study agreement will be educated to manage 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 tai chi group will perform two 60-minute tai chi 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 strength and difficulty of the exercise will be measured as secondary outcomes.Discussion This study intends to conduct a randomized controlled trial of tai chi, which is not widely practiced in Korea. This study will provide valuable data on the effects of tai chi on hypertension, to inform non-pharmaceutical treatment options for this disorder.

scholarly journals The Effects of Tai Chi on Grade 1 Hypertension: A Study Protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Sang Hyun Lee ◽  
Byung-Jun Kim ◽  
In-Hwa Park ◽  
Eui-Hyoung Hwang ◽  
Eun Ju Park ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Tai Chi ◽  
Salt Intake ◽  
Controlled Trial ◽  
Treatment Options ◽  
Treatment Method ◽  
Care Group ◽  
Randomized Controlled

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 tai chi as an exercise treatment method has been recently increasing in Korean medical practice. Numerous studies have suggested that tai chi can be used to treat various diseases and affect psychosomatic factors such as anxiety. This study aims to evaluate the effect of tai chi in reducing blood pressure among grade 1 hypertensive patients.Methods 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 tai chi group (n = 40 in each group). Subjects who voluntarily signed a study agreement will be educated to manage 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 tai chi group will perform two 60-minute tai chi 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 strength and difficulty of the exercise will be measured as secondary outcomes.Discussion This study intends to conduct a randomized controlled trial of tai chi, which is not widely practiced in Korea. This study will provide valuable data on the effects of tai chi on hypertension, to inform non-pharmaceutical treatment options for this disorder.

scholarly journals Comprehensive versus standard care in post-severe acute kidney injury survivors, a randomized controlled trial

Critical Care ◽  
2021 ◽  
Vol 25 (1) ◽  
Author(s):  
Peerapat Thanapongsatorn ◽  
Kamolthip Chaikomon ◽  
Nuttha Lumlertgul ◽  
Khanitha Yimsangyad ◽  
Akarathep Leewongworasingh ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Standard Care ◽  
Controlled Trial ◽  
Kidney Injury ◽  
Pressure Control ◽  
Comprehensive Care ◽  
Care Group ◽  
Randomized Controlled ◽  
Dietary Record ◽  
Drug Reconciliation

Abstract Background Currently, there is a lack of evidence to guide optimal care for acute kidney injury (AKI) survivors. Therefore, post-discharge care by a multidisciplinary care team (MDCT) may improve these outcomes. This study aimed to demonstrate the outcomes of implementing comprehensive care by a MDCT in severe AKI survivors. Methods This study was a randomized controlled trial conducted between August 2018 to January 2021. Patients who survived severe AKI stage 2–3 were enrolled and randomized to be followed up with either comprehensive or standard care for 12 months. The comprehensive post-AKI care involved an MDCT (nephrologists, nurses, nutritionists, and pharmacists). The primary outcome was the feasibility outcomes; comprising of the rates of loss to follow up, 3-d dietary record, drug reconciliation, and drug alert rates at 12 months. Secondary outcomes included major adverse kidney events, estimated glomerular filtration rate (eGFR), and the amount of albuminuria at 12 months. Results Ninety-eight AKI stage 3 survivors were enrolled and randomized into comprehensive care and standard care groups (49 patients in each group). Compared to the standard care group, the comprehensive care group had significantly better feasibility outcomes; 3-d dietary record, drug reconciliation, and drug alerts (p < 0.001). The mean eGFR at 12 months were comparable between the two groups (66.74 vs. 61.12 mL/min/1.73 m2, p = 0.54). The urine albumin: creatinine ratio (UACR) was significantly lower in the comprehensive care group (36.83 vs. 177.70 mg/g, p = 0.036), while the blood pressure control was also better in the comprehensive care group (87.9% vs. 57.5%, p = 0.006). There were no differences in the other renal outcomes between the two groups. Conclusions Comprehensive care by an MDCT is feasible and could be implemented for severe AKI survivors. MDCT involvement also yields better reduction of the UACR and better blood pressure control. Trial registration Clinicaltrial.gov: NCT04012008 (First registered July 9, 2019).

scholarly journals A Mobile Health Salt Reduction Intervention for People With Hypertension: Results of a Feasibility Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Sarah Payne Riches ◽  
Carmen Piernas ◽  
Paul Aveyard ◽  
James P Sheppard ◽  
Mike Rayner ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Salt Intake ◽  
Controlled Trial ◽  
Salt Content ◽  
Salt Reduction ◽  
Randomized Controlled ◽  
Secondary Outcomes

BACKGROUND A high-salt diet is a risk factor for hypertension and cardiovascular disease; therefore, reducing dietary salt intake is a key part of prevention strategies. There are few effective salt reduction interventions suitable for delivery in the primary care setting, where the majority of the management and diagnosis of hypertension occurs. OBJECTIVE The aim of this study is to assess the feasibility of a complex behavioral intervention to lower salt intake in people with elevated blood pressure and test the trial procedures for a randomized controlled trial to investigate the intervention’s effectiveness. METHODS This feasibility study was an unblinded, randomized controlled trial of a mobile health intervention for salt reduction versus an advice leaflet (control). The intervention was developed using the Behavior Change Wheel and comprised individualized, brief advice from a health care professional with the use of the SaltSwap app. Participants with an elevated blood pressure recorded in the clinic were recruited through primary care practices in the United Kingdom. Primary outcomes assessed the feasibility of progression to a larger trial, including follow-up attendance, fidelity of intervention delivery, and app use. Secondary outcomes were objectively assessed using changes in salt intake (measured via 24-hour urine collection), salt content of purchased foods, and blood pressure. Qualitative outcomes were assessed using the think-aloud method, and the process outcomes were evaluated. RESULTS A total of 47 participants were randomized. All progression criteria were met: follow-up attendance (45/47, 96%), intervention fidelity (25/31, 81%), and app use (27/31, 87%). There was no evidence that the intervention significantly reduced the salt content of purchased foods, salt intake, or blood pressure; however, this feasibility study was not powered to detect changes in secondary outcomes. Process and qualitative outcomes demonstrated that the trial design was feasible and the intervention was acceptable to both individuals and practitioners and positively influenced salt intake behaviors. CONCLUSIONS The intervention was acceptable and feasible to deliver within primary care; the trial procedures were practicable, and there was sufficient signal of potential efficacy to change salt intake. With some improvements to the intervention app, a larger trial to assess intervention effectiveness for reducing salt intake and blood pressure is warranted. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 20910962; https://www.isrctn.com/ISRCTN20910962

Does an Eczema Action Plan Improve Atopic Dermatitis? A Single-Site Randomized Controlled Trial

2018 ◽  
Vol 57 (14) ◽  
pp. 1624-1629 ◽  
Author(s):  
Julia Brown ◽  
Nicole W. Weitz ◽  
Amy Liang ◽  
Melissa S. Stockwell ◽  
Suzanne Friedman
Keyword(s):  
Randomized Controlled Trial ◽  
Atopic Dermatitis ◽  
Positive Impact ◽  
Action Plan ◽  
Controlled Trial ◽  
Treatment Options ◽  
Single Site ◽  
Care Group ◽  
Randomized Controlled ◽  
The Impact

The multitude of treatment options for atopic dermatitis (AD) makes management frustrating for providers and patients. Eczema action plans (EAPs) have been proposed to improve parental and provider management. We developed a single-site randomized controlled trial to evaluate the impact of an EAP on quality of life (QOL), provider knowledge, and comfort with AD management. Providers were randomized into an EAP-use group and a traditional care group. All patients completed validated AD QOL surveys, and those with AD were verbally administered the survey 1 month later. Providers’ perceptions on managing AD were compared in the EAP and usual use groups. Parents in the EAP group demonstrated a significantly increased understanding of AD treatment, and providers in the EAP group had a significantly increased understanding and management of AD. The EAP is a feasible tool that can be integrated into a busy clinic practice with a positive impact on physicians and patients.

Rest or 30-Min Walk as Exercise Intervention (RESTOREX) in Myasthenia Gravis: A Randomized Controlled Trial

2021 ◽  
pp. 1-7
Author(s):  
Usha K. Misra ◽  
Jayantee Kalita ◽  
Varun K. Singh ◽  
Aditya Kapoor ◽  
Abhilasha Tripathi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Myasthenia Gravis ◽  
Controlled Trial ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Secondary Endpoints

<b><i>Introduction:</i></b> There is a lack of evidence about the usefulness of exercise or rest in myasthenia gravis (MG). This study is aimed to evaluate the efficacy and safety of exercise or rest in MG. <b><i>Methods:</i></b> In a single-center open-labeled randomized controlled trial, the patients with mild to moderate MG were randomized to 30-min walk or rest in addition to the standard treatment. The primary endpoint was 50% improvement in the MG Quality of Life (MG-QOL15), and secondary endpoints were change in the Myasthenic Muscle Score (MMS), MG Activities of Daily Living (MGADL), grip strength, dose of acetylcholine esterase inhibitor and prednisone, 6-min walk test (6MWT), decrement in trapezius on the low-rate repetitive nerve stimulation test, and adverse events. The outcomes were defined at 3 months, by &#x3e;50% improvement in these outcome parameters. <b><i>Results:</i></b> Forty patients with MG were randomized to the exercise or rest arm. The 2 arms were matched for demographic and clinical parameters. The patients in the exercise arm had significantly better QOL evidenced by MG-QOL15 (<i>p =</i> 0.02). The secondary endpoints, distance covered in 6MWT (<i>p =</i> 0.007), were also better in the exercise arm without any adverse event. <b><i>Conclusion:</i></b> Regular exercise for 30 min in mild and moderate MG improves quality of life and walking distance compared to rest and is safe. <b><i>Clinical Trial Registration:</i></b> The clinical trial registration number is CTRI/2019/11/021869.

Effect of deep breathing and positive affirmation on blood pressure in essential hypertension

2017 ◽  
Vol 33 (5) ◽  
pp. 219
Author(s):  
Andi Dian Puji Lestari ◽  
Riris Andono Ahmad ◽  
Heru Prasanto
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Essential Hypertension ◽  
Controlled Trial ◽  
Deep Breathing ◽  
Lower Systolic Blood Pressure ◽  
Hypertensive Patients ◽  
Blood Pressure Decrease ◽  
Randomized Controlled ◽  
The Mean

The effect of deep breathing method and positive affirmation on blood pressure decrease in patients with essential hypertension in Kulon ProgoPurposeThe purpose of this paper was to compare the influence of deep breathing method and positive affirmation on the decrease in blood pressure in essential hypertensive patients in Kulon Progo.MethodsA randomized controlled trial was conducted involving 96 patients with essential hypertension who were randomly assigned to two intervention groups, namely deep breathing and positive affirmations. The DB group was asked to perform stomach breathing for approximately 10 minutes, while the AP group was asked to give one of the repetitive and rhythmically determined positive affirmation sentences for about 10 minutes.ResultsDeep breathing and positive affirmations can lower systolic blood pressure (11.9 ± 10.9 and 13.6 ± 10.5) and diastolic (8.3 ± 8.4 and 6.0 ± 8.6) in patients with essential hypertension. The mean blood pressure results on post1 and post2 measurements were not significantly different. The decrease in blood pressure in both groups was also not different.ConclusionThis study contributes to the knowledge that the effectiveness of deep breathing and positive affirmations in lowering blood pressure is the same. The decrease in blood pressure of both methods was stable up to 15 minutes after the intervention.

scholarly journals The impact of school uniforms on primary school student’s physical activity at school: outcomes of a cluster randomized controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Nicole Nathan ◽  
Nicole McCarthy ◽  
Kirsty Hope ◽  
Rachel Sutherland ◽  
Christophe Lecathelinais ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Primary Schools ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Trial Registration ◽  
Sedentary Activity ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Many school-based physical activity (PA) interventions are complex and have modest effects when delivered in real world contexts. A commonly reported barrier to students’ PA, particularly among girls, are uniforms that are impractical (e.g. tunic/dress and black leather shoes). Modifying student uniforms may represent a simple intervention to enhance student PA. The primary aim of this trial was to assess the impact of a PA enabling uniform intervention (shorts, polo shirt and sports shoes) on girls’ moderate-to-vigorous physical activity (MVPA) and total PA i.e. counts per minute (cpm). Methods A cluster randomized controlled trial was undertaken in 42 primary schools in New South Wales, Australia. Schools were randomized on one school day to the intervention group, where students wore a PA enabling uniform (their sports uniform) or a control group, where students wore their usual traditional uniform. Student PA was measured using wrist-worn Actigraph GT3X and GT9X accelerometers. Linear mixed models controlling for student characteristics were used to examine the effects of the intervention.. Results Of the 3351 eligible students, 2315 (69.1%) had parental consent and 2180 of these consenting students participated (94.2%) of which 1847 (84.7%) were included in the analysis. For the primary aim the study found no significant differences between girls at schools allocated to the intervention relative to the control on change in MVPA (0.76 min, 95% CI − 0.47 to 1.99, p = 0.22) or cpm (36.99, 95% CI − 13.88 to 87.86, p = 0.15). Exploratory analysis revealed small effects for a number of findings, including significant reduction in sedentary activity (− 1.77, 95% CI − 3.40 to − 0.14, p = 0.035) among all students at schools allocated to the intervention, and non-significant improvements in girls’ light intensity PA (1.47 min, 95% CI − 0.06 to 3.00, p = 0.059) and sedentary activity (− 2.23 min; 95% CI − 4.49 to 0.02, p = 0.052). Conclusion The findings suggests that the intervention may yield small improvements in some measure of PA and require substantiation in a larger RCT with longer-term follow-up. The inclusion of additional intervention components may be required to achieve more meaningful effects. Trial registration The trial was prospectively registered with Australian New Zealand Clinical Trials Register ACTRN12617001266358 1st September 2017.

scholarly journals Comprehensive Versus Standard Care in Post-Severe Acute Kidney Injury Survivors, A Randomized Controlled Trial

2021 ◽  
Author(s):  
Peerapat Thanapongsatorn ◽  
Kamolthip Chaikomon ◽  
Nuttha Lumlertgul ◽  
Khanitha Yimsangyad ◽  
Akarathep Leewongworasingh ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Standard Care ◽  
Controlled Trial ◽  
Kidney Injury ◽  
Pressure Control ◽  
Comprehensive Care ◽  
Care Group ◽  
Randomized Controlled ◽  
Dietary Record ◽  
Drug Reconciliation

Abstract Background: Currently, there is a lack of evidence to guide the optimal care for post-acute kidney injury (AKI) survivors. Therefore, post-discharge care by a multidisciplinary care team (MDCT) may improve these outcomes. This study aimed to demonstrate the outcomes of implementing comprehensive care by a MDCT in post-severe AKI survivors.Methods: This study was a randomized controlled trial conducted between August 2018 to January 2021. Patients who survived severe AKI stage 2-3 were enrolled and randomized to be followed up with either comprehensive or standard care for 12 months. The comprehensive post-AKI care integrated a MDCT (nephrologists, nurses, nutritionists, and pharmacists). The primary outcome was the feasibility outcomes, comprised of the rates of loss to follow up, specialist consultation, 3-d dietary record, drug reconciliation, and drug alert rates at 12 months. Secondary outcomes included major adverse kidney events, estimated glomerular filtration rate (eGFR), and amount of albuminuria at 12 months. Results: Ninety-eight AKI stage 3 survivors were enrolled, and randomized into comprehensive care and standard care groups (49 patients in each group). Compared to the standard care group, the comprehensive care group had significantly better in feasibility outcomes; higher rates of specialist consultation, 3-d dietary record, drug reconciliation, and drug alerts (p < 0.001). The mean eGFR at 12 months were comparable between the two groups (66.74 vs. 61.12 mL/min/1.73 m2, p = 0.54). The urine albumin: creatinine ratio (UACR) was significantly lower in the comprehensive care group (36.83 vs. 177.70 mg/g, p = 0.036), while the blood pressure control was also better in the comprehensive care group (87.9% vs. 57.5%, p = 0.006). There was no difference in the other renal outcomes between the two groups.Conclusions: Comprehensive care by a MDCT is feasible and could be implemented for post-severe AKI survivors. These resulted in a better reduction in the UACR and better blood pressure control. Trial registration: clinicaltrial.gov: NCT04012008 (First registered July 9, 2019)

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