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

Primary Purpose

Prehypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational material control
Group running style B
Group running style A
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prehypertension focused on measuring Running, Blood pressure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Osher Center for Integrative Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Experimental

Arm Label

Educational materials control

Group running style B

Group running style A

Arm Description

Enhanced usual care

Basic running instruction using group based training.

Form focused running instruction using group based training.

Outcomes

Primary Outcome Measures

Feasibility of recruitment and retention
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
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
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
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.

Full Information

First Posted
March 29, 2012
Last Updated
August 20, 2013
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01587183
Brief Title
Running Against Prehypertension Trial (RAPT): A Pilot Trial
Acronym
RAPT
Official Title
Running Against Prehypertension Trial (RAPT): A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension
Keywords
Running, Blood pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational materials control
Arm Type
Other
Arm Description
Enhanced usual care
Arm Title
Group running style B
Arm Type
Active Comparator
Arm Description
Basic running instruction using group based training.
Arm Title
Group running style A
Arm Type
Experimental
Arm Description
Form focused running instruction using group based training.
Intervention Type
Behavioral
Intervention Name(s)
Educational material control
Intervention Description
Participants will be given educational materials on starting a running program using a run/walk approach.
Intervention Type
Behavioral
Intervention Name(s)
Group running style B
Intervention Description
Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.
Intervention Type
Behavioral
Intervention Name(s)
Group running style A
Intervention Description
Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.
Primary Outcome Measure Information:
Title
Feasibility of recruitment and retention
Description
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 8 week recruitment period
Title
Feasibility and acceptability of study protocol and materials
Description
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
At the end of the 12 week study
Title
Preliminary efficacy data on changes in blood pressure
Description
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
Change in systolic and diastolic blood pressure from baseline at the end of the 12 week study
Secondary Outcome Measure Information:
Title
Preliminary efficacy data on injury incidence
Description
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.
Time Frame
At the end of the 12 week study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: Inability to provide informed consent Age < 18 years Inability to run continuously for 5 minutes (required for the gait analysis) 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 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) A history of cardiac procedures including coronary artery bypass graft, angioplasty or stent placement. Typical or atypical angina Arrhythmia, alcoholism or other condition that makes accurate BP measurement difficult A diagnosis of diabetes, chronic kidney disease or other condition indicating medication for SBP < 140mmHg Non-English speaking (group training will be given in English) Pregnant or planning to get pregnant during the study period Unwillingness or inability to commit to run/walking up to 30 minutes three times per week Plans to move from the San Francisco Bay area during the study time period 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. BMI > 30
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly McDermott, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fredrick Hecht, MD MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osher Center for Integrative Medicine
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26471194
Citation
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.
Results Reference
derived
PubMed Identifier
25633634
Citation
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.
Results Reference
derived

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Running Against Prehypertension Trial (RAPT): A Pilot Trial

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