Lifestyle Modification and Blood Pressure Study

High Blood Pressure Clinical Trial

— LIMBS  

Official title:

Lifestyle Modification and Blood Pressure Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964847
• Other study ID #: R01AT004921-01A1
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2009
• Last updated: February 13, 2017
• Start date: August 2009
• Est. completion date: June 2015

Study information

• Verified date: February 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Hospital at the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cohen D, Townsend RR. Yoga and hypertension. J Clin Hypertens (Greenwich). 2007 Oct;9(10):800-1. Review. — View Citation

Cohen DL, Bloedon LT, Rothman RL, Farrar JT, Galantino ML, Volger S, Mayor C, Szapary PO, Townsend RR. Iyengar Yoga versus Enhanced Usual Care on Blood Pressure in Patients with Prehypertension to Stage I Hypertension: a Randomized Controlled Trial. Evid Based Complement Alternat Med. 2011;2011:546428. doi: 10.1093/ecam/nep130. — View Citation

Cohen DL, Wintering N, Tolles V, Townsend RR, Farrar JT, Galantino ML, Newberg AB. Cerebral blood flow effects of yoga training: preliminary evaluation of 4 cases. J Altern Complement Med. 2009 Jan;15(1):9-14. doi: 10.1089/acm.2008.0008. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour ambulatory blood pressure		baseline, 12 weeks, 24 weeks
Secondary	Cerebral blood flow		baseline, 12 weeks, 24 weeks
Secondary	Urinary Isoprostane		baseline, 12 weeks, 24 weeks
Secondary	serum asymmetric dimethylarginine (ADMA)		baseline, 12 weeks, 24 weeks
Secondary	salivary cortisol		baseline, 12 weeks, 24 weeks
Secondary	psychological measures of mood, perceived stress and health competence		baseline, 12 weeks, 24 weeks
Secondary	physiological measures of flexibility		baseline, 12 weeks, 24 weeks