Running Against Prehypertension Trial (RAPT): A Pilot Randomized Controlled Trial
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| City: |
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San Francisco |
| State: |
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California |
| Zip Code: |
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94115 |
| Conditions: |
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Prehypertension |
| Purpose: |
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This study will test strategies to help people with prehypertension adopt a running program
to reduce their blood pressure in the long term. This study will be a 12 week intervention
of about 40 participants randomized to running educational material, group based running
instruction, or group based running instruction focused on form and all given the option to
use the supplemental mHealth intervention. The purpose of this study is to collect
feasibility, acceptability and preliminary efficacy data in preparation for a larger planned
NIH-R01 study.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- The target population for our proposed study is adults with upper range
prehypertension defined by systolic blood pressure in the range of 130-144mmHg or
diastolic blood pressure range in the range of 85-94mmHg.
- Potential participants will have two to three blood pressure screening measurements
at least one day apart taken to screen for eligibility.
- Participants also must not be currently taking antihypertensive medications and must
live in the San Francisco Bay Area.
Exclusion Criteria:
1. Inability to provide informed consent
2. Age < 18 years
3. Inability to run continuously for 5 minutes (required for the gait analysis)
4. A substance or alcohol abuse, mental health, or medical condition that, in the
opinion of investigators, will make it difficult for the potential subject to
participate in the group intervention
5. A history of cardiovascular disease or coronary artery disease including acute
coronary syndrome, heart failure, severe aortic stenosis, acute infection or fever,
or resting tachycardia (> 100 bpm)
6. A history of cardiac procedures including coronary artery bypass graft, angioplasty
or stent placement.
7. Typical or atypical angina
8. Arrhythmia, alcoholism or other condition that makes accurate BP measurement
difficult
9. A diagnosis of diabetes, chronic kidney disease or other condition indicating
medication for SBP < 140mmHg
10. Non-English speaking (group training will be given in English)
11. Pregnant or planning to get pregnant during the study period
12. Unwillingness or inability to commit to run/walking up to 30 minutes three times per
week
13. Plans to move from the San Francisco Bay area during the study time period
14. Currently exercising at vigorous intensity for greater than 90 minutes per week.
Vigorous intensity exercise may include race walking, jogging, running, hiking,
swimming laps, or bicycling ≥ 10 miles per hour.
15. BMI > 30
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| NCT ID: |
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NCT01587183 |
| Primary Contact: |
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Principal Investigator Kelly McDermott, PhD University of California, San Francisco
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| Backup Contact: |
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N/A |
| Location Contact: |
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San Francisco, California 94115 United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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