Tension Tamer Randomized Control Trial

Status Completed

Clinical Trial Summary

This study is 12 months long and consists of 5 visits at baseline, months 1, 3, 6, and 12. To determine eligibility potential subjects will have resting blood pressures (BP) measured on 2 occasions. Pre-hypertensive individuals will be invited to participate in the study. After informed consent is obtained, subjects will complete baseline visit consisting of a survey, resting BP, wear activity watch for 7 days ambulatory blood pressure monitor for 24-hours, collect saliva and urine samples. Subjects will then be randomly assigned to Tension Tamer (TT) or lifestyle education program delivered via smartphone (SPCTL) groups. At the remaining 4 visits subjects will again complete a survey, resting BP, wear activity watch for 7 days ambulatory blood pressure monitor for 24-hours, collect saliva and urine samples. Throughout the 12 months TT group will meditate twice daily and SPCTL group will log physical activity.

Clinical Trial Description

80 stage 1 or 2 pre-hypertensive adults, will be randomly assigned to 2x daily TT at scheduled decreasing doses or enhanced standard of care lifestyle education program delivered via smartphone (SPCTL) for 12 months. Subjects will participate in 5 study visits at baseline/enrollment, 1, 3, 6 , and 12 months

TT subjects will be given the TT app. The app provides instructions on breathing awareness meditation (BAM): focusing upon the moment by sustaining one's attention upon diaphragm movements and related sensations while breathing in a slow, deep, relaxed manner. One learns to passively observe thoughts, images and extraneous sounds without making judgments about them. BAM doesn't involve analysis of historical or recent stressful experiences, but instead centers upon learning to stay in the present moment while meditating. The app will also collect heart rate (HR) values during each session using the phone's camera. The duration of the TT sessions will begin at 15 min., decrease to 10 min., and finally decrease to 5 min. Adherence will be monitored by the receipt of date-stamped heart rate values collected during each meditation session.

SPCTL subjects will be provided Runkeeper app and taught how to record physical activity they perform. Recommended dosage of using SPCTL media and/or app will be that of the TT group. Adherence to SPCTL will be assessed using server file analyses of modules used and activity recorded in Runkeeper. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03168789
Study type	Interventional
Source	Medical University of South Carolina
Contact
Status	Completed
Phase	N/A
Start date	October 1, 2016
Completion date	November 22, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03313284` - Respiratory Muscle Training and Intermittent Hypoxia: Additive Health Effects?	N/A
Completed	`NCT01741779` - Diet and Whole-body Vibration Training on Cardiovascular and Autonomic Function	N/A
Withdrawn	`NCT01074918` - Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients	Phase 1/Phase 2
Completed	`NCT00288158` - Primary Prevention of Hypertension in Obese Adolescents	Phase 2
Completed	`NCT01190319` - Study: Effects of Strawberries on Blood Pressure	N/A
Completed	`NCT01008176` - Restoring Sleep Homeostasis to Lower Blood Pressure	N/A
Unknown status	`NCT02197910` - Different Dosages of Bioactive Wheat Peptides and Blood Pressure Level and CVD Risk Biomarkers in Healthy Subjects	N/A
Recruiting	`NCT04543656` - Personalized Blood Pressure Care Using IoMTs and Artificial Intelligence	N/A
Completed	`NCT00553969` - Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease	Phase 1/Phase 2
Completed	`NCT00170937` - A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan (320 mg) and Hydrochlorothiazide (25 mg) Combined and Alone, in Patients With Metabolic Syndrome	Phase 4
Completed	`NCT01741766` - The Effects of Stretching Training on Arterial Function and Autonomic Control	N/A
Completed	`NCT02143817` - Whole Body Vibration Combined With L-citrulline Supplementation on Cardiovascular Function and Body Composition	N/A
Terminated	`NCT00388388` - Losartan Versus Hydrochlorothiazide in Reversing Remodeling of Small Arteries in Pre-Hypertensive Pre-Diabetic Subjects	Phase 2
Completed	`NCT02148458` - Short Term Intermittent Fasting and Mediterranean Diet	N/A
Terminated	`NCT01349114` - Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects	Phase 4
Completed	`NCT02038179` - Center of Research Translation (CORT) Project 2	Phase 2/Phase 3
Completed	`NCT01202175` - Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension	Phase 4
Completed	`NCT00970931` - Hypertension Prevention in Pre-Hypertensive Individuals	Phase 3
Completed	`NCT01841840` - The Acute Effects of Passive Vibration on Cardiovascular Function in Individuals With Stroke	N/A
Not yet recruiting	`NCT01364675` - Primary Prevention of Cardiovascular Disease (CVD) in Pre-diabetic & Pre-hypertensive Subjects	N/A