Effects of 12-week Pilates training program on cardiac autonomic modulation: a randomized controlled clinical trial

2021 ◽  
Author(s):  
Allysiê PS Cavina ◽  
Natália M Silva ◽  
Taíse M Biral ◽  
Leonardo K Lemos ◽  
Eduardo Pizzo Junior ◽  
...  
Keyword(s):  
Training Program ◽  
Controlled Trial ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Fluctuation Analysis ◽  
Autonomic Modulation ◽  
Poincaré Plot ◽  
Rr Intervals ◽  
Cardiac Autonomic Modulation ◽  
Randomized Controlled

Aim: To evaluate the effects of 12-week Pilates training program on cardiac autonomic modulation. Materials & methods: A randomized controlled trial of a 12-week Pilates training program was conducted. A total of 54 men were randomly allocated to either a control or a Pilates group. Initially, the RR intervals were captured for 20 min for later analysis of heart rate variability (HRV). The training protocol was then initiated, in which the Pilates group performed 36 sessions of the Pilates method for approximately 60 min each session, three-times a week, totaling 12 weeks. The control group was instructed to maintain their normal activities during this period. One week after the end of the training, the final evaluations were performed with the capture of RR intervals in both the groups. Linear indices in the time (SDNN and rMSSD) and frequency (low frequency [LF] and high frequency [HF]) domains, and the Poincaré plot (SD1 and SD2) were used. Nonlinear indices were also analyzed (approximate entropy and detrended fluctuation analysis). Descriptive statistics and generalized mixed models were performed. Results: There was a group effect for LF (ms2) and a time effect for SD2. There was a training effect observed by the time*group interactions in which an increase in global HRV indices was found for the Pilates group after 12 weeks (SDNN: mean difference [MD] = 9.82; standard deviation [SD] = 18.52; ES = -0.514; LF [ms2]: MD = 334.23; SD = 669.43; ES = -0.547; SD2: MD = 14.58; SD = 24.28; ES = -0.693). Conclusion: A 12-week Pilates training program promotes significant improvement in global modulation of HRV in the Pilates group considering the significant increase in SDNN, LF (ms2) and SD2 indices. Trial registration number: NCT03232866 .

scholarly journals App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Stephanie Erika Bonn ◽  
Mari Hult ◽  
Kristina Spetz ◽  
Marie Löf ◽  
Ellen Andersson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Bariatric Surgery ◽  
Controlled Trial ◽  
Intervention Group ◽  
Study Participant ◽  
Lifestyle Factors ◽  
Lifestyle Changes ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled

BACKGROUND To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. OBJECTIVE The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. METHODS The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. RESULTS A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. CONCLUSIONS Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. CLINICALTRIAL ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19624

“Short- and mid-term effects of adding upper cervical manual therapy to a conventional physical therapy program in patients with chronic mechanical neck pain. Randomized controlled clinical trial.”

2020 ◽  
pp. 026921552096505
Author(s):  
Vanessa González-Rueda ◽  
Carlos López-de-Celis ◽  
Elena Bueno-Gracia ◽  
Jacobo Rodríguez-Sanz ◽  
Albert Pérez-Bellmunt ◽  
...  
Keyword(s):  
Neck Pain ◽  
Rating Scale ◽  
Controlled Trial ◽  
Neck Disability Index ◽  
Chronic Neck Pain ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Primary Care Center ◽  
Randomized Controlled ◽  
Upper Cervical

Objective: To evaluate the effect of adding an Upper Cervical Translatoric Mobilization (UCTM) or an Inhibitory Suboccipital Technique (IST) to a physiotherapy treatment in the symptomatology and function of mechanical chronic neck pain patients. Design: Randomized controlled trial. Setting: Primary Care Center in Cornellà, Spain. Subjects: 78 patients (64 women), with mean age (SD) of 59.96 (13.30) years with mechanical chronic neck pain were divided in three groups: control, IST and UCTM groups. Interventions: All groups received 15 physiotherapy sessions for three weeks. The UCTM and IST groups added 5 minutes of the assigned technique during six sessions. Main measures: Neck disability index (NDI) and numeric pain rating scale (NPRS) for neck pain were measured baseline, three-weeks and 15-weeks follow-up. Results: NDI (SD) at baseline, three-weeks and 15-weeks were 11.62 (7.08), 9.65 (6.25), 7.58 (5.64) for the control group, 14.38 (6.92), 8.50 (6.11), 7.12 (4.98) for the IST group and 13.19(7.23), 5.35(6.10), 4.35(2.76) for the UCTM group. NPRS (SD) at baseline, three-weeks and 15-weeks were 58.69 (19.46), 45.19 (23.43), 44.58 (24.08) for the control group; 64.08 (19.26), 42.19 (19.69), 34 (21.14) for the IST group; and 67.65 (20.65), 36.23 (20.10), 39.85 (25.44) for the UCTM group. Conclusions: Compared with no treatment, both forms of mobilization were associated with reduced disability at three weeks, and UCTM remained better than control at 15 weeks; there were no significant differences between the two mobilization groups. Trial registration: This study was registered in Clinicaltrials.gov (NCT02832232).

scholarly journals Randomized Controlled Clinical Trial Comparing Transurethral Eneucleation and Resection of Prostate and Trans-urethral Resection of Prostate in the Management of Benign Prostatic Hyperplasia

2017 ◽  
Vol 7 (3) ◽  
pp. 216-220
Author(s):  
Md Mehedi Hasan ◽  
Samira Rahat Afroze ◽  
Muhammad Abdur Rahim ◽  
Muhammad Abdus Salam
Keyword(s):  
Controlled Trial ◽  
Ethical Review ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Transurethral Resection Of Prostate ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Transurethral resection of prostate (TURP) is the predominant surgical procedure for benign prostatic hypertension (BPH) but is not devoid of complications like capsular perforation, drop in Hb%, drop in Na+, residual adenoma; hence endeavors are evolving to combat such complications. A newer technique transurethral enucleation and resection of prostate (TUERP) has been devised to solve these problems. This study was designed to compare the safety and the efficacy of newer technique, TUERP with widely practiced TURP Methods: This randomized controlled trial was done at BSMMU, after getting ethical approval from the ethical review committee of the institute, from January to October, 2009. A total of 60 BPH patients were purposively enrolled in this study, after obtaining informed written consent and they were randomized as control, Group A (30 patients, underwent TURP) and experimental group, Group B (30 patients, underwent TEURP).Results: The mean preoperative Hb% level of Group A was 15.1 gm% (SD ± 0.5) and perioperative Hb% level was 13.04 gm% (SD ± 6.06). There was significant difference (P <0.05). The mean preoperative Hb% of Group B was 15.2 gm% (SD ± 0.5) and perioperative Hb% was 15.2 gm% (SD ± 0.48). There was no difference (P >0.05). The mean preoperative Na + of Group A was 140 mmol/l (SD ± 4.1) and perioperative Na+ was 126 mmol/l (SD ± 6.8). There was significant difference (P<0.01). The mean preoperative Na+ of Group B was 136 mmol/l (SD ± 4) and perioperative Na+ was 136 mmol/l (SD ± 2.70). There was no difference (P >0.05).Conclusion: TUERP eliminates drop in Hb% and Na+which are usual consequences following TURP. Thus TUERP can be advocated in the treatment of BPH as it also allows completeresection down to surgical capsule.Birdem Med J 2017; 7(3): 216-220

scholarly journals Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial

JMIR Nursing ◽  
10.2196/20747 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. e20747
Author(s):  
Mahboube Davoudi ◽  
Tahereh Najafi Ghezeljeh ◽  
Farveh Vakilian Aghouee
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Patients With Heart Failure

Background Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

scholarly journals Baidu Jieduan granule, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial

2020 ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granule in treatment of moderate COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

scholarly journals The Lutein and Zeaxanthin in Pregnancy (L-ZIP) study—carotenoid supplementation during pregnancy: ocular and systemic effects—study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Emmanuel Kofi Addo ◽  
Aruna Gorusupudi ◽  
Susan Allman ◽  
Paul S. Bernstein
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Fetal Brain ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Safflower Oil ◽  
Retina Development ◽  
Randomized Controlled ◽  
In Pregnancy ◽  
Carotenoid Supplementation

Abstract Background Lutein (L), zeaxanthin (Z), and meso-zeaxanthin (MZ), collectively called the macular pigment (MP), are dietary carotenoids that preferentially localize in the macula of the human eye. MP protects the macula from photo-oxidative damage and enhances visual function. Inadequate maternal intake of carotenoids, coupled with the placental transfer of maternal carotenoids to support fetal brain and retina development, potentially put mothers at risk of depletion systemically and in their ocular tissues. Presently, maternal carotenoid status throughout pregnancy remains poorly characterized, and no prospective randomized controlled trial of L and Z supplementation via prenatal vitamins has assessed maternal and infants’ systemic and ocular carotenoid status during pregnancy. We hypothesize that prenatal maternal carotenoid supplementation will counteract maternal carotenoid depletion during pregnancy and will improve biomarkers of carotenoid status of both mothers and infants. Methods Lutein and Zeaxanthin in Pregnancy (L-ZIP) is a phase 2, single-center, prospective, double-masked, randomized active-controlled clinical trial conducted at the John A. Moran Eye Center, University of Utah, Salt Lake City, UT, USA. Participants consume a daily standard prenatal multivitamin with no added carotenoids and are randomized (1:1 allocation) to receive either a capsule containing 10 mg L and 2 mg Z in safflower oil (Carotenoid group) or a capsule containing only safflower oil with no added carotenoids (Control group) for a period of 6 to 8 months. Skin, serum, and ocular carotenoids are measured at every study visit (i.e., within the first trimester [baseline], second trimester, third trimester, and 0–2 weeks postpartum). Skin carotenoid assessment is by resonance Raman spectroscopy (RRS); serum carotenoid status is quantified using high-performance liquid chromatography (HPLC); and MP is measured with the dual-wavelength autofluorescence. Infants’ MP and foveal anatomy are assessed using RetCam retinal camera and Bioptigen SD-OCT, respectively. The primary outcomes are changes in maternal systemic and ocular carotenoid status during pregnancy. Discussion L-ZIP is the first prospective RCT to investigate maternal carotenoid status throughout pregnancy and to determine whether prenatal maternal carotenoid supplementation will offset maternal carotenoid depletion and improve biomarkers of maternal and infant’s carotenoid status. Findings from L-ZIP will strengthen recommendations regarding prenatal carotenoid supplementation and consequently inform policy decisions. Trial registration ClinicalTrials.gov NCT03750968. Registered on November 23, 2018

scholarly journals Effect of dental intervention on improvements in metabolic syndrome patients: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Midori Doke ◽  
Yuriko Komagamine ◽  
Manabu Kanazawa ◽  
Maiko Iwaki ◽  
Hiroyuki Suzuki ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
University Hospital ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Dental Intervention ◽  
Water Rate

Abstract Background Metabolic syndrome (MetS), caused by the accumulation of visceral fat, is considered a major cause of cardiovascular disease. This randomized controlled trial aimed to clarify the effect of dental intervention, including prosthodontics and/or periodontal treatment, combined with dietary and exercise guidance on MetS. Methods In total, 112 patients who met the Japanese waist circumference criteria of MetS were recruited. The intervention group (ITG) received dental intervention along with dietary and exercise guidance, while the control group (CTG) received dietary and exercise guidance alone. Three outcome measurements were obtained before intervention (BL), 1 month after intervention (1M), and 3 months after intervention (3M). Results Body water rate (p = 0.043) was significantly higher in ITG than in CTG at 1M. Simultaneously, fasting blood sugar level (p = 0.098) tended to be lower in ITG than in CTG. Lean mass (p = 0.037) and muscle mass (p = 0.035) were significantly higher and body weight (p = 0.044) significantly lower in ITG than in CTG at 3M. Body mass index (p = 0.052) tended to be lower in ITG than in CTG. Conclusions Dental intervention combined with lifestyle guidance may improve anthropometric status and reduce the risk of MetS. Trial registration University Hospital Medical Information Network Center Unique UMIN000022753. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000026176.

scholarly journals Parkinson's disease effect on autonomic modulation: an analysis using geometric indices

2021 ◽  
Vol 79 (2) ◽  
pp. 114-121
Author(s):  
Mileide Cristina Stoco-Oliveira ◽  
Ana Laura Ricci-Vitor ◽  
Laís Manata Vanzella ◽  
Heloisa Balotari Valente ◽  
Vitor Eduardo dos Santos Silva ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Heart Rate ◽  
Parkinson's Disease ◽  
Cross Sectional Study ◽  
Control Group ◽  
Autonomic Modulation ◽  
Poincaré Plot ◽  
Cross Sectional ◽  
Rr Intervals ◽  
Geometric Methods

ABSTRACT Background: Parkinson's disease (PD) produces autonomic changes, indicating lower parasympathetic modulation and global variability, but these changes need further studying regarding geometric methods. Objective: To investigate the autonomic modulation in individuals with PD using heart rate variability (HRV) indices obtained through geometric methods. Methods: This is a cross-sectional study that assessed 50 individuals, split into two groups: PD group (PDG; n=26; 75.36±5.21 years) and control group (CG; n=24; 75.36±5.21 years). We evaluated the autonomic modulation by measuring the heart rate beat-to-beat for 30 min with the individual in supine rest using a heart rate monitor and assessed geometric indices (RRtri, TINN, SD1, SD2, SD1/SD2 ratio, and qualitative analysis of the Poincaré plot). Results: Significant reductions were found in RRtri, TINN, SD1, and SD2 indices among PDG compared to CG. Regarding the SD1/SD2 ratio, no significant changes were detected between the groups. The Poincaré plot demonstrated that individuals with PD had lower beat-to-beat dispersion in RR intervals, in addition to greater long-term dispersion of RR intervals compared to CG. Conclusions: The results suggest a reduction in the parasympathetic autonomic modulation and global variability in individuals with PD compared to controls, regardless of sex, age, and body mass index.

scholarly journals Yiqi Fumai Injection for patients with Septic Shock: study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Bo-jun Chen ◽  
Zeng Jing ◽  
Cai Xingui ◽  
Cai Hairong ◽  
Luo Sicong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Septic Shock ◽  
Randomized Controlled Trial ◽  
Conventional Treatment ◽  
Controlled Trial ◽  
Small Sample ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Abstract Background: Septic shock is an important problem in critical care medicine and one of the leading causes of death in intensive care units (ICU). In China, Traditional Chinese medicine (TCM) has been widely used as the adjuvant treatment to improve the symptoms and prognosis in patients with septic shock. Yiqi Fumai Injection (YFI) is one of the most important proprietary TCM for septic shock, previous studies have demonstrated its efficacy and safety. However, these conclusions were limited due to the small sample size and low quality of methodologies of these studies. Therefore, we designed this study to evaluate the efficacy and safety of using YFI as an adjunct treatment for septic shock.Methods/design: This is a double-blind, randomized, parallel, placebo-controlled clinical trial. A total of 800 participants will be randomly assigned to receive either treatment or placebo in a 1:1 ratio. The treatment group will receive YFI combined with conventional treatment, and the control group will receive 0.9% sodium chloride injection combined with conventional treatment for 2 weeks. The primary outcome is the 28-days mortality. Secondary outcomes are blood lactate levels, hemodynamics, blood gas analysis, immune function indicators, inflammatory indicators, acute physiology improvement and chronic health assessment (APACHE) II scores, and sepsis-related organ failure score (SOFA). Adverse events will be observed and recorded at the same time for safety assessment.Discussion: This randomized controlled trial will help evaluate the efficacy and safety of YFI for the treatment of septic shock. The results of this trial will provide recommendations for the management of septic shock.Trial registration {2a and 2b}：China Clinical Trial Registry, ChiCTR-1900026424.Registered on 15 June 2019.

Sign in / Sign up

Export Citation Format

Share Document