N/A
N=75
Understanding the Exercise-Hypertension Paradox
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02034422 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Blood Pressure — 103; 106; 94; 101 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oral Antioxidant (Dietary_supplement); Exercise rehabilitation (Other)
- Age
- Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Pressure |
103; 106; 94; 101 | — |
Summary
Hypertension affects 37% of the Veteran population, making it the most common medical condition treated by the VA Health Care System. Physical activity is the first line of defense in the treatment and management of hypertension. However, individuals with hypertension have impaired muscle blood flow and exhibit exaggerated increases in blood pressure during exercise (exercise pressor reflex or EPR) leading to exercise intolerance and increased risk of stroke and heart attack. The cause of these impairments is not known, but it is highly likely that free radical production and the subsequent increase in oxidative stress plays a significant role. Two aims are proposed; Aim 1 will identify the physiological consequences of elevated oxidative stress in hypertension, and Aim 2 will utilize an antioxidant treatment to ameliorate the effects of an exaggerated EPR allowing the safe performance of a clinical exercise rehabilitation program which will then, itself, attenuate the EPR and reduce hypertension.
Eligibility Criteria
Inclusion Criteria
- A total of 72 middle-aged (40 - 60 years of age) healthy and hypertensive men and women will participate in these protocols after providing written informed consent.
- The investigators aim to include a 1 to 1 ratio of females and males in each group.
- Individuals diagnosed or presenting with stage 1 and stage 2 hypertension (range 140/90 to 179/109 mmHg, according to the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High BP) may be eligible for this study.
- Blood pressure status will be assessed in triplicate in the laboratory during the medical exam and during a 24 hour period using ambulatory blood pressure monitoring.
- Both methods must confer hypertension for study enrollment.
- Other than hypertension, all hypertensive patients will be otherwise healthy and free of overt disease as assessed by:
- medical history;
- standard blood chemistries (chem. 7 panel),
- ECG at rest;
- limb vascular examination (ankle-brachial BP index > 0.9);
- resting BP > 140/90 mmHg; and
- skinfold % body fat assessment.
- Subjects will have a body mass index (BMI) between 19 and 30 and have plasma glucose concentrations 240 mg/dl with LDL-cholesterol > 160 mg/dl will be excluded from participation.
- Hypertensive patients receiving dual or monotherapy treatment for hypertension may be included.
- Less frequently prescribed classes of drugs for hypertension (beta blockers, aldosterone receptor blocker, centrally acting sympatholytics, calcium channel blocker, direct vasodilators, renin inhibitors, and alpha blockers) will be excluded.
- Additionally, subjects reporting a history of myocardial infarction, unstable cardiac ischemia, recent cardiac catheterization, carotid artery disease, transient ischemic attack will be excluded.
- Participants must have no orthopedic limitations that would prohibit them from knee-extensor exercise or aerobic activity including cycle ergometry or treadmill exercise.
- Due to the age requirement of the subjects women may be either pre or post-menopausal.
- All pre-menopausal women will be studied during days 1 - 7 of their menstrual cycle to standardize the influence of female hormones.
- Women taking hormone replacement therapy (HRT) currently or in the preceding year will be excluded from the proposed studies due to the direct vascular effects of HRT and the variety of regimes employed.
- Participants will be made up of primarily Veterans.
Data sourced from ClinicalTrials.gov (NCT02034422). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.