PrehypertensionRAPTNCT01587183
Running Against Prehypertension Trial (RAPT): A Pilot Trial
A study testing Group running style B and Group running style A in people with Prehypertension, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension
- What is being tested?
- Group running style B and Group running style A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Osher Center for Integrative Medicine
San Francisco, California, 94115
About this study
Official title: 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.
Read the 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.
- Conditions
- Prehypertension
- Being tested
- Educational material control, Group running style B, Group running style A
- Keywords
- Running, Blood pressure
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational material controlBehavioural
Participants will be given educational materials on starting a running program using a run/walk approach.
Group running style BBehavioural
Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.
Group running style ABehavioural
Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.
| Study group | Role | What they receive |
|---|---|---|
| Educational materials control | Other | Enhanced usual care Receives: Behavioral: Educational material control |
| Group running style B | Active comparator | Basic running instruction using group based training. Receives: Behavioral: Group running style B |
| Group running style A | Experimental | Form focused running instruction using group based training. Receives: Behavioral: Group running style A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment and retention
We will determine feasibility associated with recruitment n by recruiting and retaining at least 75% of our intended sample.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: At the end of the 12 week study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly McDermott, PhD, Principal investigator, University of California, San FranciscoFredrick Hecht, MD MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587183
- Sponsor's protocol ID
- 12-08425
- Acronym
- RAPT
- Status last verified
- Aug 2013
- First submitted
- 29 Mar 2012
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26471194Kumar 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.
PubMed 25633634
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Running Against Prehypertension Trial (RAPT): A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01587183
- Acronym / sponsor ID
- RAPT / 12-08425
- Conditions
- Prehypertension
- Keywords
- Running, Blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Educational materials control | Other | Behavioral: Educational material controlEnhanced usual care |
| Group running style B | Active comparator | Behavioral: Group running style BBasic running instruction using group based training. |
| Group running style A | Experimental | Behavioral: Group running style AForm focused running instruction using group based training. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational material controlParticipants will be given educational materials on starting a running program using a run/walk approach. | Behavioural | Educational materials control |
| Group running style BParticipants will attend a 4 hour group based training and 3, 2 hour follow up trainings. | Behavioural | Group running style B |
| Group running style AParticipants will attend a 4 hour group based training and 3, 2 hour follow up trainings. | Behavioural | Group running style A |
Primary outcome
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.
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.
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.
1 secondary outcome
Preliminary efficacy data on injury incidence
Time frame: At the end of the 12 week study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
- Derived from this study: PubMed 26471194McDermott 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.
- Derived from this study: PubMed 25633634Kumar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly McDermott, PhD principal investigator
University of California, San Francisco
Fredrick Hecht, MD MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group running style B and Group running style A in people with Prehypertension, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment and retention (time frame: At the end of the 8 week recruitment period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01587183, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2013.