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Trial of exercise to prevent HypeRtension in young adults (TEPHRA) a randomized controlled trial: study protocol.

ABSTRACT: BACKGROUND:Hypertension prevalence in young adults has increased and is associated with increased incidence of cerebrovascular and cardiovascular events in middle age. However, there is significant debate regards how to effectively manage young adult hypertension with recommendation to target lifestyle intervention. Surprisingly, no trials have investigated whether lifestyle advice developed for blood pressure control in older adults is effective in these younger populations. METHODS/DESIGN:TEPHRA is an open label, parallel arm, randomised controlled trial in young adults with high normal and elevated blood pressure. The study will compare a supervised physical activity intervention consisting of 16 weeks structured exercise, physical activity self-monitoring and motivational coaching with a control group receiving usual care/minimal intervention. Two hundred young adults aged 18-35 years, including a subgroup of preterm born participants will be recruited through open recruitment and direct invitation. Participants will be randomised in a ratio of 1:1 to either the exercise intervention group or control group. Primary outcome will be ambulatory blood pressure monitoring at 16 weeks with measure of sustained effect at 12 months. Study measures include multimodal cardiovascular assessments; peripheral vascular measures, blood sampling, microvascular assessment, echocardiography, objective physical activity monitoring and a subgroup will complete multi-organ magnetic resonance imaging. DISCUSSION:The results of this trial will deliver a novel, randomised control trial that reports the effect of physical activity intervention on blood pressure integrated with detailed cardiovascular phenotyping in young adults. The results will support the development of future research and expand the evidence-based management of blood pressure in young adult populations. TRIAL REGISTRATION:Clinicaltrials.gov registration number NCT02723552 , registered on 30 March, 2016.

SUBMITTER: Williamson W

PROVIDER: S-EPMC6220491 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Trial of exercise to prevent HypeRtension in young adults (TEPHRA) a randomized controlled trial: study protocol.

Williamson Wilby W Huckstep Odaro J OJ Frangou Eleni E Mohamed Afifah A Tan Cheryl C Alsharqi Maryam M Bertagnolli Mariane M Lapidaire Winok W Newton Julia J Hanssen Henner H McManus Richard R Dawes Helen H Foster Charlie C Lewandowski Adam J AJ Leeson Paul P

BMC cardiovascular disorders 20181106 1

<h4>Background</h4>Hypertension prevalence in young adults has increased and is associated with increased incidence of cerebrovascular and cardiovascular events in middle age. However, there is significant debate regards how to effectively manage young adult hypertension with recommendation to target lifestyle intervention. Surprisingly, no trials have investigated whether lifestyle advice developed for blood pressure control in older adults is effective in these younger populations.<h4>Methods/ ...[more]

PMID: 30400774

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Project description:During leisure activities young people are often exposed to excessive noise levels resulting in an increase of noise-induced symptoms such as hearing loss, tinnitus and hyperacusis. Noise-induced tinnitus is often perceived after loud music exposure and provides an important marker for overexposure as a temporary threshold shift that is often not experienced by the individual itself. As oxidative stress plays an important role in the pathogenesis of noise-induced hearing loss, the use of antioxidants to prevent hearing damage has recently become the subject of research.This study proposes a randomized, double-blind, placebo-controlled crossover trial to assess the effects of a prophylactic combination of N-acetylcysteine (600 mg) and magnesium (200 mg) prior to leisure noise exposure in young adults. The primary outcome measure is the tinnitus loudness scored by a visual analogue scale (VAS). Secondary outcome measures are the differences in audiological measurements for the antioxidant treatments compared to placebo intake. Audiological testing comprising of pure tone audiometry including frequencies up to 16 kHz, distortion product otoacoustic emissions, transient-evoked otoacoustic emissions and speech-in-noise testing will be performed prior to and within 7 hours after noise exposure. By use of a mixed effects statistical model, the effects of antioxidants compared to placebo intake will be assessed.As adolescents and young adults often do not use hearing protection while being exposed to loud music, the use of preventive antioxidant intake may provide a useful and harmless way to prevent noise-induced hearing damage in this population. Furthermore, when exposed to hazardous noise levels the protection provided by hearing protectors might not be sufficient to prevent hearing damage and antioxidants may provide additive otoprotective effects. Previous research mainly focused on occupational noise exposure. The present study provides a protocol to assess the usefulness of antioxidants during leisure noise activities.The present protocol is registered at ClinicalTrials.gov: NCT01727492.

Project description:BackgroundIn response to the serious lack of physical activity among young adults, recent attempts have been made to encourage young people to exercise through exercise video distribution. However, merely distributing videos does not lead to improved physical activity levels. Metaverse space, which enables web-based interaction through avatars, allows users to watch exercise videos in the same space as other avatars.ObjectiveThis study explored whether exercise video distribution using metaverse space is effective in improving physical activity levels, along with mental health and locomotive function, among young people.MethodsIn this parallel-group randomized controlled trial participants were recruited using printed poster displays. A total of 48 young adults aged between 18 and 30 years were assigned to 3 groups of 16 each: the metaverse, YouTube, and control group. To encourage exercise, the metaverse group was given an exercise video each week with a load of around 4-8 metabolic equivalents of tasks (METs) for 8 videos delivered in the metaverse space. The YouTube group was sent a URL on YouTube every week to view exercise videos with the same content as the metaverse group. The control group was given no special instructions. The intervention period was 8 weeks. Pre- and postintervention physical activity, well-being, locomotive syndrome risk tests, and social capital were measured. Although this study was not blinded to the participants, the measurers did not know to which group the participants belonged. Mixed model repeated-measures analyses and a post hoc Wilcoxon signed rank sum test were performed to detect the effects of the intervention in all groups.ResultsThe results of the mixed model repeated-measures analyses showed a significant interaction between groups and before and after the intervention for total physical activity (metaverse group: pre 737.1, SD 609.5 METs/week, post 1575.4, SD 1071.8 METs/week; YouTube group: pre 661.7, SD 710.7 METs/week, post 911.9, SD 1103.3 METs/week; and control group: pre 930.6, SD 665.1 METs/week, post 844.7, SD 701.8 METs/week; P=.04) but none for the indicators of well-being (P=.40), locomotive function scale (P=.17), and social capital (P=.23). A post hoc test showed a significant increase in physical activity in the metaverse group before and after the intervention (P=.006).ConclusionsThis study is the first to show that delivering exercise videos through metaverse space can increase physical activity in young adults by providing a gathering space for individuals similarly motivated for exercise practice. This way, the sense of isolation during exercise is reduced compared with merely distributing videos on YouTube. The use of metaverse space in health promotion is likely to spread, and this study provides a useful reference for its exploration.Trial registrationClinicalTrials.gov NCT06019156; https://ichgcp.net/clinical-trials-registry/NCT06019156.

Project description:BACKGROUND:The risk for major depression and obesity is increased in adolescents and adults with attention-deficit / hyperactivity disorder (ADHD) and adolescent ADHD predicts adult depression and obesity. Non-pharmacological interventions to treat and prevent these co-morbidities are urgently needed. Bright light therapy (BLT) improves day-night rhythm and is an emerging therapy for major depression. Exercise intervention (EI) reduces obesity and improves depressive symptoms. To date, no randomized controlled trial (RCT) has been performed to establish feasibility and efficacy of these interventions targeting the prevention of co-morbid depression and obesity in ADHD. We hypothesize that the two manualized interventions in combination with mobile health-based monitoring and reinforcement will result in less depressive symptoms and obesity compared to treatment as usual in adolescents and young adults with ADHD. METHODS:This trial is a prospective, pilot phase-IIa, parallel-group RCT with three arms (two add-on treatment groups [BLT, EI] and one treatment as usual [TAU] control group). The primary outcome variable is change in the Inventory of Depressive Symptomatology total score (observer-blinded assessment) between baseline and ten weeks of intervention. This variable is analyzed with a mixed model for repeated measures approach investigating the treatment effect with respect to all three groups. A total of 330 participants with ADHD, aged 14 - <?30 years, will be screened at the four study centers. To establish effect sizes, the sample size was planned at the liberal significance level of ? = 0.10 (two-sided) and the power of 1-? = 80% in order to find medium effects. Secondary outcomes measures including change in obesity, ADHD symptoms, general psychopathology, health-related quality of life, neurocognitive function, chronotype, and physical fitness are explored after the end of the intervention and at the 12-week follow-up. DISCUSSION:This is the first pilot RCT on the use of BLT and EI in combination with mobile health-based monitoring and reinforcement targeting the prevention of co-morbid depression and obesity in adolescents and young adults with ADHD. If at least medium effects can be established with regard to the prevention of depressive symptoms and obesity, a larger scale confirmatory phase-III trial may be warranted. TRIAL REGISTRATION:German Clinical Trials Register, DRKS00011666. Registered on 9 February 2017. ClinicalTrials.gov, NCT03371810. Registered on 13 December 2017.

Project description:Regular physical activity (PA) is an important part of the treatment of several medical conditions, including overweight and obesity, in which there may be a weakened appetite control. Eating behaviour traits influence weight control and may be different in active and sedentary subjects. This paper reports the relationships between the time spent in sedentary behaviour and physical activity (PA) of different intensity, and eating behaviour traits in young, healthy adults. Additionally, it reports the results of a six-month-long, randomized, controlled trial to examine the effect of an exercise intervention on eating behaviour traits. A total of 139 young (22.06 ± 2.26 years) healthy adults (68.35% women) with a Body Mass Index (BMI) of 24.95 ± 4.57 kg/m2 were enrolled. Baseline assessments of habitual PA were made using wrist-worn triaxial accelerometers; eating behaviour traits were examined via the self-reported questionnaires: Binge Eating, Three-Factor Eating Questionnaire-R18 and Control of Eating Questionnaire. The subjects were then randomly assigned to one of three groups: control (usual lifestyle), moderate-intensity exercise (aerobic and resistance training 3¨C4 days/week at a heart rate equivalent to 60% of the heart rate reserve (HRres) for the aerobic component, and at 50% of the 1 repetition maximum (RM) for the resistance component), or vigorous-intensity exercise (the same training but at 80% HRres for half of the aerobic training, and 70% RM for the resistance training). At baseline, sedentary behaviour was inversely associated with binge eating (r = -0.181, p < 0.05) and with uncontrolled eating (r = -0.286, p = 0.001). Moderate PA (MPA) was inversely associated with craving control (r = -0.188, p < 0.05). Moderate-to-vigorous PA (MVPA) was directly associated with binge eating (r = 0.302, p < 0.001) and uncontrolled eating (r = 0.346, p < 0.001), and inversely associated with craving control (r = -0.170, p < 0.015). Overall, PA was directly associated with binge eating (r = 0.275, p = 0.001), uncontrolled eating (r = 0.321, p < 0.001) and emotional eating (r = 0.204, p < 0.05). Additionally, only emotional eating was modified by the intervention, increasing in the vigorous-intensity exercise group (p < 0.05). In summary, we observed that time spent in sedentary behaviour/PA of different intensity is associated with eating behaviour traits, especially binge eating in young adults. In contrast, the six-month exercise intervention did not lead to appreciable changes in eating behaviour traits.

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Trial of exercise to prevent HypeRtension in young adults (TEPHRA) a randomized controlled trial: study protocol.

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Trial of exercise to prevent HypeRtension in young adults (TEPHRA) a randomized controlled trial: study protocol.

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