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

August 20, 2013 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • Osher Center for Integrative Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Educational materials control
Enhanced usual care
Behavioral: Educational material control
Participants will be given educational materials on starting a running program using a run/walk approach.
Active Comparator: Group running style B
Basic running instruction using group based training.
Behavioral: Group running style B
Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.
Experimental: Group running style A
Form focused running instruction using group based training.
Behavioral: Group running style A
Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the 8 week recruitment period
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.
At the end of the 12 week study
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.
Change in systolic and diastolic blood pressure from baseline at the end of the 12 week study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the 12 week study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Kelly McDermott, PhD, University of California, San Francisco
  • Principal Investigator: Fredrick Hecht, MD MPH, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

April 27, 2012

First Posted (Estimate)

April 30, 2012

Study Record Updates

Last Update Posted (Estimate)

August 21, 2013

Last Update Submitted That Met QC Criteria

August 20, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-08425

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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