Prehypertension
Conditions
Keywords
Randomized clinical trial, Early medical intervention, Intervention studies, Blood pressure, Stress Management
Brief summary
The purpose of this research study is to examine the efficacy of two stress management interventions in reducing blood pressure (BP) in patients who have prehypertension (BP between 120/80 and 139/89). It is expected that participants will be better able to control their BP through reducing stress and increasing healthy lifestyle behaviors.
Interventions
BEHAVIORALMindfulness-Based Stress Reduction
Patients are randomized to an intervention
BEHAVIORALStress Management Education
Patients are randomized to an intervention
OTHERAmerican Heart Association Recommended Self-Care
All Patients receive AHA Recommended Self-Care
Sponsors
University of Pennsylvania
Case Western Reserve University
Kent State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Unmedicated high blood pressure (SBP of 120-139 or DBP of 80-89) * BMI in the range of 19-40 * Interest in attempting to control blood pressure through lifestyle modification
Exclusion criteria
* pacemakers * uncontrolled hypertension (SBP≥140 or DBP≥90) * atrial fibrillation * myocardial infarction (MI) * percutaneous transluminal coronary angioplasty (PTCA) * coronary artery bypass graft (CABG) within 6 months of enrollment * congestive heart failure * uncorrected primary valvular disease hypertrophic or restrictive cardiomyopathy * uncorrected thyroid heart disease * chronic kidney disease * persistent tachyarrhythmia * JNC risk category C (target organ damage, diabetes) * patients who are pregnant or plan to become pregnant within 9 months * patients who are lactating * patients unable to comply with assessment procedures * patients with alcohol or drug abuse within 12 months * patients who consume more than 21 alcoholic drinks per week * patients who are current smokers * patients who are unable to provide informed consent or who have dementia * patients with previous extensive meditation or yoga training * patients with blood pressure ≥140/90
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Clinic Blood Pressure | Week 0, Week 4, Week 8, Week 34, and Week 60 | All clinic blood pressure assessments will be completed in a quiet, climate controlled room according to American Heart Association guidelines. The mean of the three seated readings on the non- dominant arm will be averaged to define clinic blood pressure. |
| Change in Diastolic Clinic Blood Pressure | Week 0, Week 4, Week 8, Week 34, and Week 60 | All clinic blood pressure assessments will be completed in a quiet, climate controlled room according to American Heart Association guidelines. The mean of the three seated readings on the non- dominant arm will be averaged to define clinic blood pressure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-hour Ambulatory Systolic Blood Pressure | Week 0, Week 8, Week 60 | Participants will complete 24-hour Ambulatory Blood Pressure Monitoring with the Oscar 2 oscillometric blood pressure monitor. The Oscar will be programmed to take three blood pressure measurements per hour from 6 AM till 11 PM and two BP measurements per hour from 11 PM to 6 AM. During each reading, participants will be instructed to drop their arms to their sides as soon as they sense the cuff inflating, and to keep it relaxed and still until a few seconds after the deflation has finished. Ambulatory SBP and DBP will be derived by computing the mean of all valid readings obtained during waking hours and nighttime sleep. |
| Change in 24-hour Ambulatory Diastolic Blood Pressure | Week 0, Week 8, Week 60 | Participants will complete 24-hour Ambulatory Blood Pressure Monitoring with the Oscar 2 oscillometric blood pressure monitor. The Oscar will be programmed to take three blood pressure measurements per hour from 6 AM till 11 PM and two BP measurements per hour from 11 PM to 6 AM. During each reading, participants will be instructed to drop their arms to their sides as soon as they sense the cuff inflating, and to keep it relaxed and still until a few seconds after the deflation has finished. Ambulatory SBP and DBP will be derived by computing the mean of all valid readings obtained during waking hours and nighttime sleep. |
Countries
United States
Outcome results
None listed