Clinical trial NCT01587183: Running Against Prehypertension Trial (RAPT): A Pilot Trial
Official title: Running Against Prehypertension Trial (RAPT): A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehypertension
Keywords: Running
Blood pressure
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The UCSF Osher Center for Integrative Medicine has increasingly been investigating lifestyle interventions and their upstream approach to improving health and well-being. Many such lifestyle interventions address health risk nonpharmacologically and present participants with the opportunity to change their overall trajectory of health. Exercise interventions are of particular interest based on evidence of numerous physical and mental health benefits. Our target population in the Running Against Prehypertension Trial (RAPT) was people with upper range prehypertension. By adopting and maintaining a running program, these individuals who are at a high risk of hypertension can avoid a lifetime of medication and chronic disease. The objective of RAPT was to collect feasibility, acceptability and preliminary efficacy data over a 12 week period on a running program aimed at teaching a natural running form called ChiRunning that used the mindful movement principles of Tai Chi. By using this natural running form, participants may increase satisfaction and decrease rates of injury towards greater adherence to the program. Participants were randomized to one of three study arms: 1) intervention, 8 weeks of group training in form focused ChiRunning; 2) active control, 8 weeks of group training focused on conventional running excluding form; or 3) usual care, a self-directed training with educational materials.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of recruitment and retention
timeFrame: At the end of the 8 week recruitment period
measure: Feasibility and acceptability of study protocol and materials
timeFrame: At the end of the 12 week study
measure: Preliminary efficacy data on changes in blood pressure
timeFrame: Change in systolic and diastolic blood pressure from baseline at the end of the 12 week study
Secondary outcomes:
measure: Preliminary efficacy data on injury incidence
timeFrame: At the end of the 12 week study
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kelly McDermott, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Fredrick Hecht, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: McDermott K, Kumar D, Goldman V, Feng H, Mehling W, Moskowitz JT, Souza RB, Hecht FM. Training in ChiRunning to reduce blood pressure: a randomized controlled pilot study. BMC Complement Altern Med. 2015 Oct 15;15:368. doi: 10.1186/s12906-015-0895-x.
citation: Kumar D, McDermott K, Feng H, Goldman V, Luke A, Souza RB, Hecht FM. Effects of Form-Focused Training on Running Biomechanics: A Pilot Randomized Trial in Untrained Individuals. PM R. 2015 Aug;7(8):814-822. doi: 10.1016/j.pmrj.2015.01.010. Epub 2015 Jan 26.