Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Exercise to Prevent HypeRtension in Young Adults (TEPHRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02723552
Recruitment Status : Not yet recruiting
First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Collaborators:
Wellcome Trust
Oxford Brookes University
Information provided by (Responsible Party):
University of Oxford

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.


Condition or disease Intervention/treatment Phase
Hypertension Premature Birth Behavioral: Aerobic Exercise Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial of Exercise to Prevent HypeRtension in Young Adults
Study Start Date : March 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Control participants undergo no intervention.
Experimental: Exercise
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
40 minute aerobic exercise sessions 3x/week.




Primary Outcome Measures :
  1. 16 Week Blood Pressure [ Time Frame: Measured at baseline and upon completion of 16 week intervention ]
    Systolic and Diastolic blood pressure measured during 24 hour ambulatory blood pressure at baseline and upon completion of 16 week intervention


Secondary Outcome Measures :
  1. 52 Week Blood Pressure [ Time Frame: Measured at baseline and at 52 weeks post baseline ]
    Systolic and Diastolic blood pressure measured during 24 hour ambulatory blood pressure at baseline and 52 weeks post randomisation

  2. Peak VO2 [ Time Frame: Measured at: - baseline - upon completion of 16 week intervention - 52 weeks post randomisation ]
    Oxygen uptake and carbon dioxide exchange kinetics across submaximal and peak exercise

  3. Vascular Stiffness [ Time Frame: Measured at: - baseline - upon completion of 16 week intervention - 52 weeks post randomisation ]
    Arterial Pulse Wave Velocity

  4. Cardiac Imaging (3D) [ Time Frame: Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation ]
    Cardiac MRI ( MRI subgroup n=100) to assess 3D-shape analysis

  5. Cardiac Imaging (ventricular fxn) [ Time Frame: Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation ]
    Cardiac Echocardiography (all participants n=200) 7 Cardiac MRI ( MRI subgroup n=100) to quantify Ventricular Function

  6. Cardiac Imaging (mass) [ Time Frame: Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation ]
    Cardiac Echocardiography (all participants n=200) & Cardiac MRI ( MRI subgroup n=100) to quantify cardiac mass

  7. Microvascular Imaging [ Time Frame: Measured at: - baseline - upon completion of 16 week intervention - 52 weeks post randomisation ]
    Dermal and Retinal Capillaroscopy

  8. Blood Analysis [ Time Frame: Measured at: - baseline - upon completion of 16 week intervention - 52 weeks post randomisation ]
    Whole, plasma, and serum blood samples at rest and following peak exercise testing

  9. Brain Imaging (anatomical) [ Time Frame: Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation ]
    Brain MRI (MRI subgroup n=100) quantifying ventricular volume and shape

  10. Brain Imaging (lesions) [ Time Frame: Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation ]
    Brain MRI (MRI subgroup n=100) quantification of white matter lesions

  11. Brain Imaging (vascular) [ Time Frame: Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation ]
    Brain MRI (MRI subgroup n=100) quantification of Vessel Density and Tortuosity

  12. Hepatic Imaging (anatomical) [ Time Frame: Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation ]

    Liver MRI (MRI sub-group n=100) anatomocal chara

    • Structure and volume
    • Intra-hepatic lipid content
    • Steatohepatitis
    • Hepatic fibrosis

  13. Hepatic Imaging (fibrosis) [ Time Frame: Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation ]
    Liver MRI (MRI sub-group n=100) quantification of hepatic fibrosis

  14. Hepatic Imaging (steatohepatitis) [ Time Frame: Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation ]
    Liver MRI (MRI sub-group n=100) quantification of intra-hepatic lipid content

  15. Physical Activity [ Time Frame: Measured at: - baseline - upon completion of 16 week intervention - 52 weeks post randomisation ]
    Objective measure of physical activity (7 day wear of activity monitor) Self-reported questionnaire responses, including self-reported physical activity questionnaires, cognitive and psycho-social questionnaire items and self-efficacy measures.


Other Outcome Measures:
  1. Participant Experience [ Time Frame: End of Trial ]
    Optional exit interview of study experience

  2. Economic Evaluation [ Time Frame: 36 Month Trial ]

    Assessment of feasibility for scaling intervention to multi-centre trial including intervention process evaluation by assessing:

    EQ-5D-5L health questionnaire results Structured interviews (study team and personnel) Review of medical notes/GP consultations




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)
  • 24 hour awake ABP greater than 115/75 mmHg
  • Able (in the investigator's opinion) and willing to comply with all study requirements.

Exclusion Criteria:

  • Clinic blood pressure greater than 159mmHg systolic and/or 99mmHg diastolic at initial screening
  • Pregnancy
  • 24 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

The following are exclusion criteria for the MRI sub-study only:

  • a permanent pacemaker • shrapnel injuries
  • metal clips in blood vessels of the brain • other metal or electronic implants affected by the magnetic field
  • Unsuitable for MRI based on responses on the MRI safety screening form
  • an injury to the eye involving fragments of metal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723552


Contacts
Layout table for location contacts
Contact: Odaro J Huckstep, MSc 1865572833 odaro.huckstep@cardiov.ox.ac.uk
Contact: Wilby Williamson, BMBS, MSc 1865572833 wilby.williamson@cardiov.ox.ac.uk

Locations
Layout table for location information
United Kingdom
Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
University of Oxford
Wellcome Trust
Oxford Brookes University
Investigators
Layout table for investigator information
Principal Investigator: Paul M Leeson, Phd, FRCP University of Oxford, Division of Cardiovascular Medicine, Cardiovascular Clinical Research Facility

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02723552     History of Changes
Other Study ID Numbers: TEPHRA Version 1 16/SC/0016
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016

Keywords provided by University of Oxford:
preeclampsia
young adult hypertension
preterm birth

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Premature Birth
Vascular Diseases
Cardiovascular Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications