Trial of Exercise to Prevent HypeRtension in Young Adults

NCT02723552 | Completed DMC

• 1 other identifier: TEPHRA Version 1 16/SC/0016
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

TEPHRA investigates the effect of exercise on blood pressure and other cardiovascular factors in young adults with different birth histories. TEPHRA will recruit 200 participants from 18-35 years old with elevated blood pressure (100 participants pre-term born and 100 full-term born). Half of the participants from each birth group will be randomised into a 16 week supervised aerobic exercise intervention trial and the other half will be controls. Participants will complete 3 main study visits:

• Visit 1: Baseline visit conducted at beginning of study
• Visit 2: 16 weeks into study (upon completion of structured exercise intervention for the exercise group)
• Visit 3: End of study (52 weeks) Each visit will repeat the same set of cardiovascular measures including CPET, echo, blood pressure, vascular stiffness, and other measures. 50 participants from each group will complete an MRI sub-study of the heart, brain, and liver.

Conditions

Hypertension; Premature Birth

Keywords

preeclampsia; young adult hypertension; preterm birth

Outcome Measures

Primary Outcomes (1)

• 16 Week Blood Pressure

  Systolic and Diastolic blood pressure measured during 24 hour ambulatory blood pressure at baseline and upon completion of 16 week intervention

  Measured at baseline and upon completion of 16 week intervention

Secondary Outcomes (15)

• 52 Week Blood Pressure

  Measured at baseline and at 52 weeks post baseline

• Peak VO2

  Measured at: - baseline - upon completion of 16 week intervention - 52 weeks post randomisation

• Vascular Stiffness

  Measured at: - baseline - upon completion of 16 week intervention - 52 weeks post randomisation

• Cardiac Imaging (3D)

  Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation

• Cardiac Imaging (ventricular fxn)

  Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation

Other Outcomes (2)

• Participant Experience

  End of Trial

• Economic Evaluation

  36 Month Trial

Study Arms (2)

Control

NO INTERVENTION

Control participants undergo no intervention.

Exercise

EXPERIMENTAL

Exercise group participants will undergo 16 weeks of 3x/week supervised aerobic exercise of at least 40 minutes per session. After the supervised exercise phase, they will be monitored and supported to maintain an increased physical activity level for eight months.

Behavioral: Aerobic Exercise

Interventions

Aerobic Exercise BEHAVIORAL

40 minute aerobic exercise sessions 3x/week.

Exercise

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, from 18 to 35 years old.
• Verified birth history: preterm birth (\<37 weeks) or full-term birth (\>37 weeks)
• Ability to access and use computer/internet
• Willing to complete duration of intervention, follow-up and attend study visits at the John Radcliffe Hospital (participants may still withdraw at any time without providing an explanation or rationale)
• hour awake ABP greater than 115/75 mmHg
• Able (in the investigator's opinion) and willing to comply with all study requirements.

You may not qualify if:

• Clinic blood pressure greater than 159mmHg systolic and/or 99mmHg diastolic at initial screening
• Pregnancy
• hour awake ABP greater than 150mmHg systolic and/or 95mmHg diastolic
• Clinic blood pressure greater than 140mmHg systolic and/or 90 mmHg diastolic plus evidence of end organ damage secondary to hypertension
• Simultaneous participation in another human or clinical randomized trial (if there is any possibility of compromising health, safety, or well-being, or any possible compromise of study data)
• Unable to walk briskly on the flat for 15 minutes
• Those currently maintaining levels of cardiovascular fitness and activity at or above the levels required for the intervention arm
• Unable to attend the regular supervised exercise sessions
• Use of beta-blockers such as atenolol or equivalent
• BMI \>35 kg/m2
• Major contra-indications to exercise participation
• Evidence of cardiomyopathy
• Evidence of inherited cardiac conduction abnormalities
• Evidence of congenital heart disease or significant chronic disease relevant to cardiovascular status
• a permanent pacemaker • shrapnel injuries

Sponsors & Collaborators

• University of Oxford: lead
• Wellcome Trust: collaborator
• Oxford Brookes University: collaborator

Study Sites (1)

Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related Publications (8)

• Bertagnolli M, Luu TM, Lewandowski AJ, Leeson P, Nuyt AM. Preterm Birth and Hypertension: Is There a Link? Curr Hypertens Rep. 2016 Apr;18(4):28. doi: 10.1007/s11906-016-0637-6.

  PMID: 26951245 BACKGROUND

• Boardman H, Birse K, Davis EF, Whitworth P, Aggarwal V, Lewandowski AJ, Leeson P. Comprehensive multi-modality assessment of regional and global arterial structure and function in adults born preterm. Hypertens Res. 2016 Jan;39(1):39-45. doi: 10.1038/hr.2015.102. Epub 2015 Sep 24.

  PMID: 26399455 BACKGROUND

• Lewandowski AJ, Davis EF, Yu G, Digby JE, Boardman H, Whitworth P, Singhal A, Lucas A, McCormick K, Shore AC, Leeson P. Elevated blood pressure in preterm-born offspring associates with a distinct antiangiogenic state and microvascular abnormalities in adult life. Hypertension. 2015 Mar;65(3):607-14. doi: 10.1161/HYPERTENSIONAHA.114.04662. Epub 2014 Dec 22.

  PMID: 25534704 BACKGROUND

• Lewandowski AJ, Bradlow WM, Augustine D, Davis EF, Francis J, Singhal A, Lucas A, Neubauer S, McCormick K, Leeson P. Right ventricular systolic dysfunction in young adults born preterm. Circulation. 2013 Aug 13;128(7):713-20. doi: 10.1161/CIRCULATIONAHA.113.002583.

  PMID: 23940387 BACKGROUND

• Lapidaire W, Forkert ND, Williamson W, Huckstep O, Tan CM, Alsharqi M, Mohamed A, Kitt J, Burchert H, Mouches P, Dawes H, Foster C, Okell TW, Lewandowski AJ, Leeson P. Aerobic exercise increases brain vessel lumen size and blood flow in young adults with elevated blood pressure. Secondary analysis of the TEPHRA randomized clinical trial. Neuroimage Clin. 2023;37:103337. doi: 10.1016/j.nicl.2023.103337. Epub 2023 Jan 24.

  PMID: 36709637 DERIVED

• Burchert H, Lapidaire W, Williamson W, McCourt A, Dockerill C, Woodward W, Tan CMJ, Bertagnolli M, Mohamed A, Alsharqi M, Hanssen H, Huckstep OJ, Leeson P, Lewandowski AJ. Aerobic Exercise Training Response in Preterm-Born Young Adults with Elevated Blood Pressure and Stage 1 Hypertension: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2023 May 1;207(9):1227-1236. doi: 10.1164/rccm.202205-0858OC.

  PMID: 36459100 DERIVED

• Williamson W, Lewandowski AJ, Huckstep OJ, Lapidaire W, Ooms A, Tan C, Mohamed A, Alsharqi M, Bertagnolli M, Woodward W, Dockerill C, McCourt A, Kenworthy Y, Burchert H, Doherty A, Newton J, Hanssen H, Cruickshank JK, McManus R, Holmes J, Ji C, Love S, Frangou E, Everett C, Hillsdon M, Dawes H, Foster C, Leeson P. Effect of moderate to high intensity aerobic exercise on blood pressure in young adults: The TEPHRA open, two-arm, parallel superiority randomized clinical trial. EClinicalMedicine. 2022 May 13;48:101445. doi: 10.1016/j.eclinm.2022.101445. eCollection 2022 Jun.

  PMID: 35706495 DERIVED

• Williamson W, Huckstep OJ, Frangou E, Mohamed A, Tan C, Alsharqi M, Bertagnolli M, Lapidaire W, Newton J, Hanssen H, McManus R, Dawes H, Foster C, Lewandowski AJ, Leeson P. Trial of exercise to prevent HypeRtension in young adults (TEPHRA) a randomized controlled trial: study protocol. BMC Cardiovasc Disord. 2018 Nov 6;18(1):208. doi: 10.1186/s12872-018-0944-8.

  PMID: 30400774 DERIVED

MeSH Terms

Conditions

Hypertension; Premature Birth; Pre-Eclampsia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Paul M Leeson, Phd, FRCP

  University of Oxford, Division of Cardiovascular Medicine, Cardiovascular Clinical Research Facility

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 30, 2016
• Study Start: June 23, 2016
• Primary Completion: March 29, 2019
• Study Completion: November 26, 2019
• Last Updated: February 2, 2021

Record last verified: 2016-03

Locations

GB (1)