Running Against Prehypertension Trial (RAPT): A Pilot Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01587183
First received: March 29, 2012
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Prehypertension
Behavioral: Educational material control
Behavioral: Group running style B
Behavioral: Group running style A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Running Against Prehypertension Trial (RAPT): A Pilot Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Feasibility of recruitment and retention [ Time Frame: At the end of the 8 week recruitment period ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Preliminary efficacy data on injury incidence [ Time Frame: At the end of the 12 week study ] [ Designated as safety issue: No ]
    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.


Enrollment: 22
Study Start Date: March 2012
Study Completion Date: June 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01587183

Locations
United States, California
Osher Center for Integrative Medicine
San Francisco, California, United States, 94115
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01587183     History of Changes
Other Study ID Numbers: 12-08425
Study First Received: March 29, 2012
Last Updated: August 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Running
Blood pressure

Additional relevant MeSH terms:
Prehypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014