Osher Center for Integrative Medicine
San Francisco, California, 94115, United States
NCT Number: NCT01587183
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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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
San Francisco, California, 94115, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be given educational materials on starting a running program using a run/walk approach.
Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.
Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.
Time frame: At the end of the 8 week recruitment period
We will determine feasibility associated with recruitment n by recruiting and retaining at least 75% of our intended sample.
Time frame: At the end of the 12 week study
We will conduct both qualitative and quantitative analysis of the evaluations provided by participants to improve study protocol and materials and to indicate feasibility and acceptability of the study content. We will consider at least 75% of participants being "satisfied" or higher in the overall study evaluation to indicate acceptability of the study materials. We will consider completing at least 75% of the intended gait analyses and feedback from the lab specialists to indicate feasibility and a "satisfied" or higher score by at least 75% of participants as being acceptable.
Time frame: Change in systolic and diastolic blood pressure from baseline at the end of the 12 week study
For the preliminary efficacy data we will compare systolic and diastolic blood pressure changes between baseline and post intervention to determine effect size to make sample size calculations for a larger planned trial.
Time frame: At the end of the 12 week study
For the preliminary efficacy data on injury incidence across the three study groups. Data on injury incidence will be collected using the training diary questions about whether a run was missed due to injury.
University of California, San Francisco
Other
Running Against Prehypertension Trial (RAPT): A Pilot Randomized Controlled Trial
Acronym: RAPT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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