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. 2018 Nov 6;18(1):208.
doi: 10.1186/s12872-018-0944-8.

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

Wilby Williamson  1 , Odaro J Huckstep  2 , Eleni Frangou  3 , Afifah Mohamed  2 , Cheryl Tan  2 , Maryam Alsharqi  2 , Mariane Bertagnolli  2   4 , Winok Lapidaire  2 , Julia Newton  5 , Henner Hanssen  6 , Richard McManus  7 , Helen Dawes  8 , Charlie Foster  9 , Adam J Lewandowski  2   10 , Paul Leeson  2
Affiliations

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

Wilby Williamson et al. BMC Cardiovasc Disord. .

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.

Keywords: Blood pressure; Cardiac Remodelling; Cardiac imaging; Cerebrovascular health; Exercise; Hypertension; Prehypertension; Preterm birth; Randomised trial; Young adult.

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Conflict of interest statement

Ethics approval and consent to participate

The protocol, informed consent form, participant information sheets, digital platforms and proposed advertising materials were approved by the University of Oxford as host institution and study Sponsor and the South Central Research Ethics Committee (REC) for the National Health Service Health Research Authority (NHS HRA) (Reference 16/SC/0016). The investigators will submit and, where necessary, obtain approval from the above parties for all substantial amendments to the original approved documents. It is the requirement of the trial that written informed consent is obtained prior to the enrolment of the participants. The investigators will ensure that the study is conducted in accordance with the principles of the Declaration of Helsinki. The investigators will ensure that the study is conducted in accordance with relevant regulations and Good Clinical Practice.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
TEPHRA Trial Overview and Visit Schedule. Provides an overview of the study, describing the study inclusion and exclusion criteria, study visits, and summary of intervention arms
See this image and copyright information in PMC

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