Running Against Prehypertension Trial (RAPT): A Pilot Trial

Prehypertension Clinical Trial

— RAPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587183
• Other study ID #: 12-08425
• Status: Completed
• Phase: N/A
• First received: March 29, 2012
• Last updated: August 20, 2013
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prehypertension

Intervention

Behavioral:
• Educational material control
Participants will be given educational materials on starting a running program using a run/walk approach.
• Group running style B
Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.
• Group running style A
Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.

Locations

Country	Name	City	State
United States	Osher Center for Integrative Medicine	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No