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      Dose-response effects of high-intensity interval neuromuscular exercise training on weight loss, performance, health and quality of life in inactive obese adults: Study rationale, design and methods of the DoIT trial

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          Abstract

          Obesity is associated with high mortality and morbidity rates and low levels of quality of life among adults globally. It is critical to examine evidence-based practices for developing lifestyle behavioral changes such as physical movement and structured exercise training. The DoIT protocol, a high-intensity interval exercise training (HIIT) program, effectively reduces body mass, alters energy balance, and improves performance of obese adults with a high adherence rate. This study aims to determine the dose-response effects of the DoIT protocol on body composition, health, performance and quality of life in sedentary obese adults. This study will recruit 88 sedentary, obese males and females (BMI 25.0–34.9; 30–50 years) who will be randomly assigned to one of four groups: (i) control (n = 22), (ii) one session/week (n = 22), (iii) two sessions/week (n = 22) or (iv) three sessions/week (n = 22). DoIT will use a supervised, circuit-type (1–3 rounds), functional/neuromotor and progressive exercise program for 12 months. DoIT incorporates 8–12 multi-planar, fundamental and complex, whole body movements and uses bodyweight and alternative exercise modes as a resistance. DoIT utilizes prescribed work-to-rest ratios which will be varied every four weeks. Each session will last less than 30 min. DoIT will be implemented for a year and its effects on body mass and body composition, physical fitness, functional capacity, bone health, leptin, adiponectin, blood lipids, glycemic control, inflammation, oxidative stress and quality of life will be assessed. The outcomes of the proposed study will provide insight on optimal exercise prescription guidelines for such HIIT-type exercise protocols for overweight or obese individuals.

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          High-intensity interval training in patients with lifestyle-induced cardiometabolic disease: a systematic review and meta-analysis.

          Cardiorespiratory fitness (CRF) is a strong determinant of morbidity and mortality. In athletes and the general population, it is established that high-intensity interval training (HIIT) is superior to moderate-intensity continuous training (MICT) in improving CRF. This is a systematic review and meta-analysis to quantify the efficacy and safety of HIIT compared to MICT in individuals with chronic cardiometabolic lifestyle diseases. The included studies were required to have a population sample of chronic disease, where poor lifestyle is considered as a main contributor to the disease. The procedural quality of the studies was assessed by use of a modified Physiotherapy Evidence Base Database (PEDro) scale. A meta-analysis compared the mean difference (MD) of preintervention versus postintervention CRF (VO2peak) between HIIT and MICT. 10 studies with 273 patients were included in the meta-analysis. Participants had coronary artery disease, heart failure, hypertension, metabolic syndrome and obesity. There was a significantly higher increase in the VO2peak after HIIT compared to MICT (MD 3.03 mL/kg/min, 95% CI 2.00 to 4.07), equivalent to 9.1%. HIIT significantly increases CRF by almost double that of MICT in patients with lifestyle-induced chronic diseases. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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            Effects of high-intensity interval training on cardiometabolic health: a systematic review and meta-analysis of intervention studies.

            The current review clarifies the cardiometabolic health effects of high-intensity interval training (HIIT) in adults. A systematic search (PubMed) examining HIIT and cardiometabolic health markers was completed on 15 October 2015. Sixty-five intervention studies were included for review and the methodological quality of included studies was assessed using the Downs and Black score. Studies were classified by intervention duration and body mass index classification. Outcomes with at least 5 effect sizes were synthesised using a random-effects meta-analysis of the standardised mean difference (SMD) in cardiometabolic health markers (baseline to postintervention) using Review Manager 5.3. Short-term (ST) HIIT (<12 weeks) significantly improved maximal oxygen uptake (VO2 max; SMD 0.74, 95% CI 0.36 to 1.12; p<0.001), diastolic blood pressure (DBP; SMD -0.52, 95% CI -0.89 to -0.16; p<0.01) and fasting glucose (SMD -0.35, 95% CI -0.62 to -0.09; p<0.01) in overweight/obese populations. Long-term (LT) HIIT (≥12 weeks) significantly improved waist circumference (SMD -0.20, 95% CI -0.38 to -0.01; p<0.05), % body fat (SMD -0.40, 95% CI -0.74 to -0.06; p<0.05), VO2 max (SMD 1.20, 95% CI 0.57 to 1.83; p<0.001), resting heart rate (SMD -0.33, 95% CI -0.56 to -0.09; p<0.01), systolic blood pressure (SMD -0.35, 95% CI -0.60 to -0.09; p<0.01) and DBP (SMD -0.38, 95% CI -0.65 to -0.10; p<0.01) in overweight/obese populations. HIIT demonstrated no effect on insulin, lipid profile, C reactive protein or interleukin 6 in overweight/obese populations. In normal weight populations, ST-HIIT and LT-HIIT significantly improved VO2 max, but no other significant effects were observed. Current evidence suggests that ST-HIIT and LT-HIIT can increase VO2 max and improve some cardiometabolic risk factors in overweight/obese populations.
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              Sample Size Estimation in Clinical Trial

              Every clinical trial should be planned. This plan should include the objective of trial, primary and secondary end-point, method of collecting data, sample to be included, sample size with scientific justification, method of handling data, statistical methods and assumptions. This plan is termed as clinical trial protocol. One of the key aspects of this protocol is sample size estimation. The aim of this article is to discuss how important sample size estimation is for a clinical trial, and also to understand the effects of sample size over- estimation or under-estimation on outcome of a trial. Also an attempt is made to understand importance of minimum sample to detect a clinically important difference. This article is also an attempt to provide inputs on different parameters that impact sample size and basic rules for these parameters with the help of some simple examples.
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                Author and article information

                Contributors
                Journal
                Contemp Clin Trials Commun
                Contemp Clin Trials Commun
                Contemporary Clinical Trials Communications
                Elsevier
                2451-8654
                23 May 2019
                September 2019
                23 May 2019
                : 15
                : 100386
                Affiliations
                [a ]School of Physical Education and Sport Sciences, University of Thessaly, Karies, Trikala, 42100, Greece
                [b ]School of Physical Education and Sport Sciences, Democritus University of Thrace, Komotini, 69100, Greece
                Author notes
                []Corresponding author. ifatouros@ 123456pe.uth.gr
                Article
                S2451-8654(19)30006-7 100386
                10.1016/j.conctc.2019.100386
                6543184
                31193901
                0ef43bf4-3480-4ec4-9d62-8c7a9598ab82
                © 2019 Published by Elsevier Inc.

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 27 December 2018
                : 1 May 2019
                : 22 May 2019
                Categories
                Article

                obesity,body composition,high-intensity interval training,metabolic health,physical fitness,enjoyment

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