TEPHRA Version 1
Research type
Research Study
Full title
Trial of Exercise to Prevent Hypertension in Young Adults
IRAS ID
194729
Contact name
Paul Leeson
Contact email
Sponsor organisation
University of Oxford
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
TEPHRA includes a 16 week exercise intervention and associated follow up measures which investigate multiple research aims.\n\nDesign \nA randomized control trial investigating the cardiovascular effects (blood pressure, structure, and function) of aerobic exercise intervention in young adults with elevated blood pressure. The trial will compare outcomes in premature born participants vs full-term born participants.\n\nBackground and Aims\n1 in 10 babies are born preterm and studies have identified preterm birth to be associated with increased risk of high blood pressure and reduced exercise capacity. This trial aims to advance the understanding of how aerobic exercise affects blood pressure and cardiovascular structure and function in adults aged 18-35 with elevated blood pressure and varying birth backgrounds. \n\nParticipants:\n200 participants (100 preterm born & 100 full term born) aged 18-35 with elevated blood pressure.\n\nRecruitment:\n1. Open advertising \n2. Hypertension Services at the John Radcliffe Hospital\n3. Previous study participants \n4. Local GP surgeries\n\nStudy Procedures\nCandidates will attend the Cardiovascular Clinical Research Facility, John Radcliffe Hospital for a brief screening visit to assess eligibility. Participants will complete 3 study visits (baseline, 16 week, and 52 week). Study visits will include measures of: height, weight, blood pressure and vascular function, and body composition--donation of blood samples, completing a questionnaire, ultrasound imaging of the heart, exercise testing, optical imaging of small blood vessels, and fitting with a 24 hour blood pressure monitor and 7 day accelerometer. A sub-study completing MRI scans of the heart, liver, and brain will be done on a total of 100 participants (50 full term, 50 premature)\n\nIntervention: Half of participants will be randomized into a 16 week supported exercise program after the baseline visit. \n\nManagement \nThe trial will be managed by the Cardiovascular Clinical Research Facility, Division of Cardiovascular Medicine, University of Oxford. Funding is from the Wellcome Trust and the Principal Investigator is Professor Paul Leeson.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0016
Date of REC Opinion
27 Jan 2016
REC opinion
Further Information Favourable Opinion