NCT01587183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 21, 2013

Status Verified

August 1, 2013

Enrollment Period

6 months

First QC Date

March 29, 2012

Last Update Submit

August 20, 2013

Conditions

Prehypertension

Keywords

RunningBlood pressure

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (1)

  • Preliminary efficacy data on injury incidence

    At the end of the 12 week study

Study Arms (3)

Educational materials control

OTHER

Enhanced usual care

Behavioral: Educational material control

Group running style B

ACTIVE COMPARATOR

Basic running instruction using group based training.

Behavioral: Group running style B

Group running style A

EXPERIMENTAL

Form focused running instruction using group based training.

Behavioral: Group running style A

Interventions

Educational material controlBEHAVIORAL

Participants will be given educational materials on starting a running program using a run/walk approach.

Educational materials control
Group running style BBEHAVIORAL

Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.

Group running style B
Group running style ABEHAVIORAL

Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.

Group running style A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osher Center for Integrative Medicine

San Francisco, California, 94115, United States

Location

Related Publications (2)

  • 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.

    PMID: 26471194DERIVED

  • 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.

    PMID: 25633634DERIVED

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Kelly McDermott, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Fredrick Hecht, MD MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 30, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2012

Study Completion

June 1, 2013

Last Updated

August 21, 2013

Record last verified: 2013-08

Locations

US(1)