scholarly journals Load monitoring on Pilates training: a study protocol for a randomized clinical trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Allysiê Priscilla de Souza Cavina ◽  
Eduardo Pizzo Junior ◽  
Aryane Flauzino Machado ◽  
Taíse Mendes Biral ◽  
Carlos Marcelo Pastre ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Heart Rate ◽  
Visual Analogue Scale ◽  
Randomized Clinical Trial ◽  
Analogue Scale ◽  
Scientific Evidence ◽  
Training Session ◽  
Preventive Measure ◽  
Training Load ◽  
Subjective Perception

Abstract Background Currently there are campaigns to raise the awareness of the need to practice physical exercise with several objectives, mainly as a preventive measure. The Pilates method is a form of therapeutic exercise for maintaining and improving health. However, despite being popular, there is still no scientific evidence on the standardization and progression of the method. Therefore, the purpose of this study was to develop a protocol to monitor the progression of daily Pilates loads between the basic, intermediate, and advanced levels, as well as to analyze the effects of the method on psychometric, cardiorespiratory, and autonomic measures. Methods/design In total, 54 healthy men underwent 36 sessions of Pilates mat work. Before each training session, cardiorespiratory measures, pain (visual analogue scale), and a psychometric questionnaire were collected. Heart rate (HR), subjective perception of effort (SPE), and RR intervals were measured during the sessions and used later in the analysis of the progression of training load by monitoring the internal training load and heart rate variability. At the end of the sessions, cardiorespiratory measures, the visual analogue scale, and the psychometric questionnaire were measured again. After 15 min of rest, the final HR measurement was made and the participants noted the effort on the SPE scale. The psychometric, cardiorespiratory, and autonomic measures were evaluated before and after each of the 36 training sessions. Discussion This is a parallel randomized clinical trial of standardized Pilates training, with the aim of estimating training loads and measuring the efficacy of Pilates through clinical, cardiorespiratory, and autonomic outcomes. The protocol can easily be reproduced and could be used to support professionals in prescribing the method. Trial registration ClinicalTrials.gov, NCT03232866. Registered on 28 July 2017.

scholarly journals Load monitoring on Pilates training: a study protocol for a randomized clinical trial

2019 ◽  
Author(s):  
Allysiê P. S. Cavina ◽  
Eduardo Pizzo Junior ◽  
Aryane Flauzino Machado ◽  
Taise Mendes Biral ◽  
Carlos Marcelo Pastre ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Heart Rate ◽  
Randomized Clinical Trial ◽  
Scientific Evidence ◽  
Training Session ◽  
Subjective Perception ◽  
Therapeutic Exercise ◽  
Load Monitoring ◽  
Before And After ◽  
Pilates Method

Abstract Background: Currently there are campaigns to raise the awareness of the need to practice some physical exercise with several objectives, mainly as a preventive character. From this perspective, we can see the use of the Pilates method as an instrument of therapeutic exercise for the protection and promotion of health. However, despite being popularly performed, there is still no scientific evidence on the standardization of the use of the method and its progression to an adequate prescription of physical training. Therefore, the purpose of the study was to develop a protocol to monitor the progression of Pilates loads daily between the basic, intermediate and advanced levels, as well as to analyze the effect of the method on the psychometric, cardiorespiratory and autonomic parameters. Methods: there will be a total of 36 sessions of Pilates mat for 32 healthy men. In each training session, initially, cardiorespiratory parameters, pain through the Visual Analogue Scale (VAS), and a psychometric questionnaire will be collected for the volunteers. Heart rate (HR), subjective perception of effort (SPE), and RR intervals will be measured during the sessions for subsequent use to analyze the progression of the loads by monitoring the internal training load and heart rate variability (HRV), respectively. At the end of the sessions, cardiorespiratory parameters, the VAS, the psychometric questionnaire will be measured again and the participants will only be released after 15 minutes of rest for the final HR analysis and to re-respond to the PSE scale. Before and after the 36 sessions of training, participants will also be evaluated in relation to psychometric, cardiorespiratory, and autonomic parameters. Discussion: this study deserves to be highlighted as it is a parallel randomized clinical trial with standardization of training, with the purpose of monitoring the prescription of loads of the method, as well as verifying its efficacy in clinical, cardiorespiratory, and autonomic outcomes. The easy reproducibility of the protocol from its description, also improves the study, besides providing support for prescribing the method to the professionals involved.

scholarly journals Load monitoring on Pilates training: a study protocol for a randomized clinical trial

2019 ◽  
Author(s):  
Allysiê P. S. Cavina ◽  
Eduardo Pizzo Junior ◽  
Aryane Flauzino Machado ◽  
Taise Mendes Biral ◽  
Carlos Marcelo Pastre ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Heart Rate ◽  
Randomized Clinical Trial ◽  
Scientific Evidence ◽  
Training Session ◽  
Subjective Perception ◽  
Therapeutic Exercise ◽  
Load Monitoring ◽  
Before And After ◽  
Pilates Method

Abstract Background: Currently there are campaigns to raise the awareness of the need to practice some physical exercise with several objectives, mainly as a preventive character. From this perspective, we can see the use of the Pilates method as an instrument of therapeutic exercise for the protection and promotion of health. However, despite being popularly performed, there is still no scientific evidence on the standardization of the use of the method and its progression to an adequate prescription of physical training. Therefore, the purpose of the study was to develop a protocol to monitor the progression of Pilates loads daily between the basic, intermediate and advanced levels, as well as to analyze the effect of the method on the psychometric, cardiorespiratory and autonomic parameters. Methods: there will be a total of 36 sessions of Pilates mat for 54 healthy men. In each training session, initially, cardiorespiratory parameters, pain through the Visual Analogue Scale (VAS), and a psychometric questionnaire will be collected for the volunteers. Heart rate (HR), subjective perception of effort (SPE), and RR intervals will be measured during the sessions for subsequent use to analyze the progression of the loads by monitoring the internal training load and heart rate variability (HRV), respectively. At the end of the sessions, cardiorespiratory parameters, the VAS, the psychometric questionnaire will be measured again and the participants will only be released after 15 minutes of rest for the final HR analysis and to re-respond to the PSE scale. Before and after the 36 sessions of training, participants will also be evaluated in relation to psychometric, cardiorespiratory, and autonomic parameters. Discussion: this study deserves to be highlighted as it is a parallel randomized clinical trial with standardization of training, with the purpose of monitoring the prescription of loads of the method, as well as verifying its efficacy in clinical, cardiorespiratory, and autonomic outcomes. The easy reproducibility of the protocol from its description, also improves the study, besides providing support for prescribing the method to the professionals involved.

Heart Rate Variability And Respiratory Muscle Strength In Patients With Type Ii Diabetes Practicing Pilates: A Randomized Clinical Trial

2021 ◽  
Vol 17 ◽  
Author(s):  
Samara Sousa Vasconcelos Gouveia ◽  
Guilherme Pertinni de Morais Gouveia ◽  
Leydnaya Maria Souza ◽  
Bruno Cunha da Costa ◽  
Gustavo Henrique Melo Sousa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Heart Rate ◽  
Heart Rate Variability ◽  
Muscle Strength ◽  
Normal Distribution ◽  
Randomized Clinical Trial ◽  
Respiratory Muscle ◽  
Control Group ◽  
Respiratory Muscle Strength

Purpose: This study aimed to analyze the effect of a Pilates protocol on respiratory muscle strength and heart rate variability (HRV) in patients with type 2 diabetes. Method: A randomized clinical trial (RBR-2gc2qj) was conducted with a type 2 diabetic target population. Patients practiced the Pilates protocol for 8 weeks, with two visits per week. The variables tested were maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), and HRV (time and frequency domains). All variables were tested for normal distribution. Using SPSS 21.0, analysis of variance was performed for variables with normal distribution, and the Wilcoxon and Friedman tests were used for variables that did not show a normal distribution, with a 5% significance level. Results: Forty-four participants were included in the study (intervention group: 22; control group: 22; mean age: 61.23 ± 8.49 years), most of whom were female (77.3%), married or in a consensual union (59.1%), had complete literacy (31.8%), and had an average body mass index of 26.96 ± 4.35 kg/m2. There were no significant differences in MIP and MEP before and after the protocol between the intervention and control groups. Regarding HRV, there were significant differences in autonomic modulation, especially between the moments before and during exercise and between the moments during and after exercise; however, it was not possible to determine which system (sympathetic or parasympathetic) is most involved in these changes. Conclusion: The exercise protocol based on the Pilates method did not alter respiratory muscle strength but promoted changes in HRV, especially between the moments before and during exercise and during and after exercise.

scholarly journals Evaluation of Methods to Minimize Pain in Newborns during Capillary Blood Sampling for Screening: A Randomized Clinical Trial

2022 ◽  
Vol 19 (2) ◽  
pp. 870
Author(s):  
Magdalena Napiórkowska-Orkisz ◽  
Aleksandra Gutysz-Wojnicka ◽  
Mariola Tanajewska ◽  
Iwona Sadowska-Krawczenko
Keyword(s):  
Clinical Trial ◽  
Heart Rate ◽  
Heart Rate Variability ◽  
Pain Management ◽  
Pain Relief ◽  
Pain Intensity ◽  
Randomized Clinical Trial ◽  
Capillary Blood ◽  
Pain Outcome ◽  
Capillary Blood Sampling

Aim: The aim of the study was to assess the severity of pain experienced by a newborn during a heel puncture for screening using the Newborn Pain Scale (NIPS), measure the heart rate and compare the effectiveness of non-pharmacological methods of pain control. Design: Randomized clinical trial. No experimental factors. The test was performed during routine screening. Surroundings: Provincial Specialist Hospital in Olsztyn. Patients/Participants: Pain was assessed in 90 full-term newborns. The newborns were rooming in with their mothers in the hospital. Interventions: Newborns were divided into three groups. Three different methods of pain relief were used: breastfeeding, 20% glucose administered orally and non-nutritional sucking. Main Outcome Measures: The primary pain outcome was measured using the NIPS and the secondary pain outcome measures (heart rate, oxygen saturation) were measured using a pulse oximeter. Results: During capillary blood sampling from the heel, most newborns, n = 56 (62.2%), experienced no pain or mild discomfort, severe pain occurred in n = 23 (25.6%) and moderate pain occurred in n = 11 (12.2%). No significant statistical differences were found between the degree of pain intensity and the intervention used to minimize the pain p = 0.24. Statistically significant relationships were demonstrated between heart rate variability and the degree of pain intensity (p = 0. 01). There were no statistically significant differences between the newborn’s pain intensity and the mother’s opinion on the effectiveness of breastfeeding in minimizing pain. Conclusions: This study did not answer the question of which pain management method used during the heel prick was statistically more effective in reducing pain. However, the results indicate that each of the non-pharmacological interventions (breastfeeding, oral glucose dosing and non-nutritive sucking) applied during heel puncture resulted in effective pain management in most of the newborns enrolled in the study. The relationship between heart rate variability and the severity of pain was confirmed. Mothers of newborns in the breastfeeding group were satisfied with the pain relief methods used in the child and the opportunity to console their newborn during painful procedures in a technologically invasive environment.

Checkmate 577:Health-related quality of life (HRQoL) in a randomized, double-blind phase III study of nivolumab (NIVO) versus placebo (PBO) as adjuvant treatment in patients (pts) with resected esophageal or gastroesophageal junction cancer (EC/GEJC).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 167-167
Author(s):  
Eric Van Cutsem ◽  
Prianka Singh ◽  
James M. Cleary ◽  
Ronan Joseph Kelly ◽  
Markus H. Moehler ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Visual Analogue Scale ◽  
Repeated Measures ◽  
Analogue Scale ◽  
Gastroesophageal Junction ◽  
Neoadjuvant Chemoradiotherapy ◽  
Phase Iii ◽  
Meaningful Improvement ◽  
Utility Index ◽  
Patient Reported

167 Background: NIVO is the first adjuvant therapy to provide a statistically significant and clinically meaningful improvement in disease-free survival (DFS) versus PBO in resected EC/GEJC following neoadjuvant chemoradiotherapy as demonstrated by CheckMate 577. NIVO was well tolerated with an acceptable safety profile. This analysis provides additional information on the exploratory HRQoL endpoints in this clinical trial. Methods: The effect of NIVO versus PBO on HRQoL, including general and disease-related symptoms, functioning, disease burden, and overall QoL, was assessed using FACT-E and EQ-5D-3L patient-reported outcome (PRO) questionnaires administered at baseline (BL), every 4 weeks during the 12-month treatment period, and at post-treatment follow-up visits (up to 2 years after last dose). Longitudinal change from BL in PRO scores over 12 months was assessed using descriptive statistics. Additionally, mixed model for repeated measures and time to deterioration analyses evaluated the difference between treatment with NIVO and PBO (data not shown). Results: 794 pts with EC/GEJC were randomized 2:1 to NIVO (n = 532) or PBO (n = 262). PRO completion rates were ≥ 95% at BL and ~ 90% at 12 months on treatment. Mean (SD) BL HRQoL scores were similar between treatment arms for the FACT-E total score (NIVO: 133.40 [20.97]; PBO: 134.03 [20.40]); esophageal cancer subscale (ECS; NIVO: 50.2 [9.3]; PBO: 50.1 [8.9]); EQ-5D Visual Analogue Scale (NIVO: 70.4 [22.3]; PBO: 69.1 [24.1]); and EQ-5D Utility Index (NIVO: 0.820 [0.179]; PBO: 0.831 [0.163]) based on the UK value set. Descriptive analyses showed a trend for increases from baseline at most time points through week 49 for both NIVO and PBO treatment groups for FACT-E total score, ECS, and EQ-5D Visual Analogue Scale and Utility Index. Conclusions: Preliminary results from CheckMate 577 demonstrated that pts on NIVO treatment showed trends of improvement in both esophageal-specific and general HRQoL. Similar trends were also observed in pts treated with PBO over 1 year. Pts treated with NIVO did not experience a reduction in HRQoL, further supporting clinical data to demonstrate treatment benefit and tolerability for adjuvant NIVO in pts with resected EC/GEJC. Clinical trial information: NCT02743494.

scholarly journals Effect of nicotine 6 mg gum on urges to smoke, a randomized clinical trial

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Anna Hansson ◽  
Thomas Rasmussen ◽  
Roland Perfekt ◽  
Elin Hall ◽  
Holger Kraiczi
Keyword(s):  
Clinical Trial ◽  
Smoking Cessation ◽  
Clinical Study ◽  
Visual Analogue Scale ◽  
Replacement Therapy ◽  
Success Rate ◽  
Analogue Scale ◽  
Healthy Adult ◽  
Nicotine Gum ◽  
Search Query

Abstract Background Ability to manage urges to smoke is fundamental to maximizing the chances of success in smoking cessation. Previous studies have linked a higher dose of nicotine in nicotine replacement therapy to a higher success rate for smoking cessation. Thus, this study was performed to compare relief of urges to smoke, up until 5 h following treatment with a new 6 mg nicotine gum versus currently marketed 4 mg nicotine gum. Methods This was a randomized crossover clinical study. Following 12 h of abstinence from smoking, either one 6 mg or one 4 mg nicotine gum was given to 240 healthy adult smokers. Thereafter, urges to smoke were scored on a 100 mm Visual Analogue Scale repeatedly over 5 h. Results The reductions in urges to smoke over the first 1 and 3 h after administration were statistically significantly greater with 6 mg than 4 mg gum, (p < 0.005). A 50% reduction in perceived urges to smoke was reached in 9.4 min with 6 mg gum compared to 16.2 min with 4 mg gum (median values). The median duration of a 50% or more reduction in VAS urges to smoke score was 111 min with the 6 mg gum, versus 74 min for the 4 mg gum. Conclusion This study provides evidence that the 6 mg nicotine gum provided a greater reduction, faster and longer relief of urges to smoke than the 4 mg nicotine gum. Trial registration EudraCT Number: 2010–023268-42. Study was first entered in EudraCT 2011-02-23.

scholarly journals Randomized Clinical Trial: The Effect of Exercise of the Intrinsic Muscle on Foot Pronation

2020 ◽  
Vol 17 (13) ◽  
pp. 4882 ◽  
Author(s):  
Manuel Pabón-Carrasco ◽  
Aurora Castro-Méndez ◽  
Samuel Vilar-Palomo ◽  
Ana María Jiménez-Cebrián ◽  
Irene García-Paya ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Scientific Evidence ◽  
Control Group ◽  
Initial State ◽  
Post Intervention ◽  
Before And After ◽  
Training Post ◽  
Foot Posture ◽  
Statics And Dynamics

Background: There is little scientific evidence regarding the effectiveness of strengthening exercises on the foot’s intrinsic musculature in improving the lower limb on the statics and dynamics in healthy individuals. Method: To evaluate the effect on foot posture with regard to the reinforcement of the short foot exercise (SFE) compared to another without a recognized biomechanical action, which we called the “non-biomechanical function” (NBF) exercise. A randomized clinical trial was carried out with 85 asymptomatic participants with a bilateral Foot Posture Index (FPI) greater than 6 points. An experimental group (n = 42) did SFE training and a control group (n = 43) carried out NBF exercises. The foot posture was evaluated twice via the navicular drop (ND) test, and the FPI was assessed on the day of inclusion in the study (pre-intervention) and after four weeks of training (post-intervention). Results: Statistically significant values were not found in foot posture between the experimental and the control groups when comparing before and after the training. However, the foot posture was modified in both groups with respect to its initial state, and the ND value decreased. Conclusions: SFE could be considered a useful tool to deal with pathologies whose etiology includes excessive pronation of the foot.

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