Trial of Exercise to Prevent HypeRtension in Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- 16 Week Blood Pressure
研究概览
简要总结
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.
详细描述
DESIGN TEPHRA is a 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.
SCIENTIFIC JUSTIFICATION 1 in 4 adults develop high blood pressure, a risk factor for heart disease and stroke. Although high blood pressure is becoming more common in younger adults, recent literature review shows that most research on exercise and blood pressure has focused on older populations. The effect of exercise on the blood pressure of preterm born young adults has not been well studied or reported. Most babies are born full term (between 37-42 weeks gestation) but 1 in 10 babies are born early (preterm). Evidence suggests that preterm birth may be associated with higher blood pressures and differences in the size, shape and function of the heart and blood vessels. These differences may alter how a person's blood pressure and cardiovascular system respond to exercise. These factors contributed to the investigators pursuing this research study.
The trial is a vehicle to learn more about hypertension in young adults and how exercise helps reduce blood pressure. It will investigate the structure and function of the cardiovascular system and how it responds to exercise. It will specifically seek to improve understanding of how birth histories, such as being born premature may influence blood pressure and response to exercise training.
This trial seeks to illuminate clinically relevant information for one of the most prevalent diseases in the UK (hypertension).
BACKGROUND AND AIMS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
16 Week Blood Pressure
时间窗: 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
次要结局
- Vascular Stiffness(Measured at: - baseline - upon completion of 16 week intervention - 52 weeks post randomisation)
- Cardiac Imaging (mass)(Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation)
- 52 Week Blood Pressure(Measured at baseline and at 52 weeks post baseline)
- Cardiac Imaging (3D)(Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation)
- Microvascular Imaging(Measured at: - baseline - upon completion of 16 week intervention - 52 weeks post randomisation)
- Brain Imaging (lesions)(Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation)
- Peak VO2(Measured at: - baseline - upon completion of 16 week intervention - 52 weeks post randomisation)
- Brain Imaging (anatomical)(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)
- Blood Analysis(Measured at: - baseline - upon completion of 16 week intervention - 52 weeks post randomisation)
- Brain Imaging (vascular)(Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation)
- Hepatic Imaging (anatomical)(Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation)
- Hepatic Imaging (fibrosis)(Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation)
- Hepatic Imaging (steatohepatitis)(Measured at: baseline - 16 weeks post randomisation - 52 weeks post randomisation)
- Physical Activity(Measured at: - baseline - upon completion of 16 week intervention - 52 weeks post randomisation)