Lifestyle Modification and Blood Pressure Study (LIMBS)

February 13, 2017 updated by: University of Pennsylvania
The purpose of this study is to compare the effects of 24 weeks of either a blood pressure education and walking program versus a yoga exercise program versus the combined intervention of blood pressure education and yoga on reducing mild to moderate high blood pressure in pre-hypertension and stage 1 hypertension subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a non-blinded, randomized controlled trial to assess the safety and efficacy of 24 weeks of a structured yoga exercise program (YP) versus a blood pressure education and walking program (BPEP) versus the combined intervention on reducing mild to moderate high blood pressure in adults with pre-hypertension or stage 1 hypertension. This will be done through a single center trial using a parallel design. All potential subjects will be screened first by telephone and then by 2 outpatient visits at the Clinical and Translational Research Center (CTRC) at the hospital of the University of Pennsylvania. Eligible subjects will then make 3 visits to the CTRC where they will be admitted overnight to have non-invasive 24-hour recordings of BP, as well as have periodic blood, urine and saliva collections. The entire study duration is 28 weeks (24 weeks post-randomization) and includes a total of 7 evaluation visits (including 2 functional magnetic resonance imaging visits) and a termination visit. Subjects will be randomized to YP, BPEP or the combined intervention of YP and BPEP.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital at the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must be willing and able to give written informed consent.
  • Age > 18 years, but < 75 years.
  • BP criteria: Systolic Blood Pressure (SBP) of > 130, but < 160 mm Hg.
  • Willing to comply with all study-related procedures.

Exclusion Criteria:

  • Subjects who are pregnant or post partum < 3 months.
  • Subjects currently taking BP lowering medications or dietary supplements (magnesium, potassium, calcium > 1200 mg/day, fish oils, ephedra, hawthorn, forskolin, etc…).
  • Stage II HTN (SBP > 160 mmHg OR diastolic blood pressure (DBP) > 100 mmHg).
  • Non-dominant arm circumference > 50 cm.
  • BMI > 40.0 kg/m2.
  • Practicing yoga >1x/month in the previous 6 months.
  • Received/used experimental drug or device within 30 days prior to screening, or donated blood > 1 pint within 8 weeks of screening.
  • Diabetes mellitis.
  • Established cardiovascular disease.
  • Known arrhythmias or cardiac pacemakers.
  • Current users (within 30 days) of any tobacco products.
  • History of renal insufficiency (glomerular filtration rate < 60 ml/min).
  • Women consuming > 7 alcoholic drinks/week; men consuming > 14 drinks/week.
  • Known autonomic neuropathy.
  • Known secondary cause of HTN (renal artery stenosis, pheochromocytoma, coarctation of aorta, hyperaldosteronism).
  • Benzodiazepine, anti-psychotic drugs (3 month stable use of SSRIs are allowed), or steroid use.
  • Known severe musculoskeletal problems such as spinal stenosis that may limit participation in yoga.
  • Use of other mind/ body therapies such as Qi Gong, Tai Chi, meditation.
  • Lack Internet access.
  • Presence of non-removable metallic foreign object, surgically implanted electrical device, surgically placed metallic clip (aneurysm clip), ear implants, any history of metal implants in the eye.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Blood pressure education/walking program
Behavioral: Blood pressure education/walking program
The program will consist of small group health education classes and a walking program. Subjects will be expected to attend a dietician-led nutrition class twice a month. On alternate weeks the subjects will be given either motivational talks about a variety of topics including weight loss, walking programs, and healthy lifestyle choices or they will be given educational DVDs or literature to read on the weeks that they are not attending a BPEP class. These subjects will all receive 12 nutrition classes and 12 motivational experiences. The subjects will also be expected to walk 6 days a week gradually increasing to 180 minutes of walking per week or 10,000 steps per day.
Other Names:
  • BPEP
ACTIVE_COMPARATOR: Combined intervention
Behavioral: Blood pressure education/walking program
The program will consist of small group health education classes and a walking program. Subjects will be expected to attend a dietician-led nutrition class twice a month. On alternate weeks the subjects will be given either motivational talks about a variety of topics including weight loss, walking programs, and healthy lifestyle choices or they will be given educational DVDs or literature to read on the weeks that they are not attending a BPEP class. These subjects will all receive 12 nutrition classes and 12 motivational experiences. The subjects will also be expected to walk 6 days a week gradually increasing to 180 minutes of walking per week or 10,000 steps per day.
Other Names:
  • BPEP
Behavioral: Yoga exercise program
Subjects in the yoga exercise program participate in structured bi-weekly 1.5 hour yoga classes held at a yoga studio as well as develop a weekly hour-long home practice over the 6 months of the study.
Other Names:
  • YP
EXPERIMENTAL: Yoga Exercise Program
Behavioral: Yoga exercise program
Subjects in the yoga exercise program participate in structured bi-weekly 1.5 hour yoga classes held at a yoga studio as well as develop a weekly hour-long home practice over the 6 months of the study.
Other Names:
  • YP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24-hour ambulatory blood pressure
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cerebral blood flow
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 12 weeks, 24 weeks
Urinary Isoprostane
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 12 weeks, 24 weeks
serum asymmetric dimethylarginine (ADMA)
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 12 weeks, 24 weeks
salivary cortisol
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 12 weeks, 24 weeks
psychological measures of mood, perceived stress and health competence
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 12 weeks, 24 weeks
physiological measures of flexibility
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 12 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Debbie Cohen, M.D., University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (ESTIMATE)

August 25, 2009

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AT004921-01A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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