Clinical Trial: Running Against Prehypertension Trial (RAPT): A Pilot Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Running Against Prehypertension Trial (RAPT): A Pilot Randomized Controlled Trial

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 Summary: 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.
Sponsor: University of California, San Francisco

Current Primary Outcome:

  • Feasibility of recruitment and retention [ 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.
  • Feasibility and acceptability of study protocol and materials [ 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.
  • Preliminary efficacy data on changes in blood pressure [ 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.


Original Primary Outcome:

  • Feasibility or recruitment [ 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.
  • Feasibility and acceptability of study protocol and materials [ 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.
  • Preliminary efficacy data on changes in blood pressure [ 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.


Current Secondary Outcome: Preliminary efficacy data on injury incidence [ 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.


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: March 29, 2012
Date Started: March 2012
Date Completion:
Last Updated: August 20, 2013
Last Verified: August 2013