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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational materials control | Other | Enhanced usual care |
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| Group running style B | Active Comparator | Basic running instruction using group based training. |
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| Group running style A | Experimental | Form focused running instruction using group based training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational material control | Behavioral | Participants will be given educational materials on starting a running program using a run/walk approach. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of recruitment and retention | We will determine feasibility associated with recruitment n by recruiting and retaining at least 75% of our intended sample. | At the end of the 8 week recruitment period |
| Feasibility and acceptability of study protocol and materials | 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. | At the end of the 12 week study |
| Preliminary efficacy data on changes in blood pressure | 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. | Change in systolic and diastolic blood pressure from baseline at the end of the 12 week study |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary efficacy data on injury incidence | 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. | At the end of the 12 week study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly McDermott, PhD | University of California, San Francisco | Principal Investigator |
| Fredrick Hecht, MD MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osher Center for Integrative Medicine | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26471194 | Derived | 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. | |
| 25633634 | Derived | 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. |
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Group running style B | Behavioral | Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings. |
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| Group running style A | Behavioral | Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings. |
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