NCT00964847

Lifestyle Modification and Blood Pressure Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• High Blood Pressure

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2009-08-25
• Last updated: 2017-02-15

Locations

1 site across 1 country: United States