Diet and Whole-body Vibration Training on Cardiovascular and Autonomic Function
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|ClinicalTrials.gov Identifier: NCT01741779|
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : December 5, 2012
Obesity is a major risk factor for premature arterial abnormalities including high blood pressure and increased stiffness. Previous studies have shown that weight loss via lifestyle modifications is associated with a decrease in large artery (aorta) stiffness. However, along with decreases in fat mass, hypocaloric diet reduces muscle mass. Whole body vibration results in similar increases in muscle mass and strength than those observed after resistance exercise and is feasible for special populations such as the obese and the elderly.
The investigators hypothesis is that weight loss via diet combined with whole body vibration training would additively reduce arterial stiffness and blood pressure in obese women. The investigators also hypothesize that the improved arterial function with weight loss would be associated with beneficial changes in the main mechanisms involved in BP regulation.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Pre-hypertension Hypertension||Other: Whole Body Vibration Training Other: Hypocaloric diet Other: Whole body vibration training & diet||Not Applicable|
The purpose of the study is to examine the effects of 12 weeks of whole body vibration training (WBVT) and diet on arterial function, autonomic function, and body composition in obese women. Specific aims of the study are to:
To evaluate the extent to which diet and (WBVT) will improve body composition assessed by changes in fat mass and lean mass using dual-energy x-ray absorptiometry and waist circumference.
To investigate that combined diet and (WBVT) are more efficacious than either treatment alone in ameliorating cardiovascular disease risk factors by assessing arterial stiffness (aortic, systemic, and leg), aortic BP and wave reflection, and autonomic function (heart rate variability, vascular sympathetic activity [low-frequency power of systolic BP variability], and baroreflex sensitivity). Flow mediated dilation and circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NO metabolites [NOx], 6-keto PGFIa, insulin, and ghrelin) and vasoconstrictors (endothelin-1 [ET-1],8-iso PGF2a,vascular endothelium growth factor [VGEF]) will be assessed as secondary outcome variables.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Diet and Whole-body Vibration Training on Cardiovascular and Autonomic Function in Obese Postmenopausal Women|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Experimental: Hypocaloric diet
This arm involves 12 wk of the standard Nutrisystem foods plan complemented by fresh produce and dairy. Subjects consume breakfast, lunch, dinner, and one (women) or two (men) snacks per day.
Other: Hypocaloric diet
The hypocaloric diet intervention consists of 12 wk of the standard Nutrisystem foods plan complemented by fresh produce and dairy. Subjects consume breakfast, lunch, dinner, and one (women) or two (men) snacks per day.
No Intervention: Control
This arm involves not making any change to the subject's lifestyle at the moment of the start of the intervention and for 12 wk.
Experimental: Whole body vibration training & diet
Lower-body exercise training on a vibration platform and diet
Other: Whole body vibration training & diet
Combination of whole body vibration training and hypocaloric diet
Experimental: Whole body vibration training
Lower-body exercises 3 times per wk for 12 wk in a vibration platform
Other: Whole Body Vibration Training
The Whole body vibration training intervention consists of lower-body exercise in a vibration platform 3 times per wk for 12 wk. The subjects will perform static and dynamic exercises for the legs on the vibration platform. Dynamic exercises will be performed with slow controlled movements starting from an upright position into a 60 degree knee flexion (squat) and maximal heel elevation (toestand). Static exercises will be performed without movement in the joint angles described previously. The training volume will increase progressively over the 12-week training period by increasing the intensity of vibration, duration of the exercise set (30-60 sec), number of sets per exercise, and total duration of the training session, and decreasing the duration of rest periods (30-60 sec).The intensity of vibration and amplitude will also be increased progressively (25-30 Hz of frequency and from low to high amplitude).
- Body Composition [ Time Frame: 12 weeks ]By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference
- Blood pressure [ Time Frame: 12 weeks ]Non-invasive measures of brachial and aortic blood pressure
- Arterial Stiffness [ Time Frame: 12 weeks ]Using pulse wave velocity of the aorta, systemic, and legs
- Pressure Wave Reflection [ Time Frame: 12 weeks ]Using the augmentation index from radial tonometry
- Autonomic Function [ Time Frame: 12 weeks ]Heart rate variability, vascular sympathetic activity [low-frequency power of systolic BP variability], and spontaneous baroreflex sensitivity will be assessed from electrocardiogram and beat-by-beat digital blood pressure
- Endothelial Function [ Time Frame: 12 weeks ]By measuring circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NOx, 6-keto PGFIa, insulin, and ghrelin)and vasoconstrictors (ET-1 and 8-iso PGF2a, VEGF)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741779
|United States, Florida|
|Florida State University|
|Tallahassee, Florida, United States, 32306|
|Principal Investigator:||Arturo Figueroa, M.D., Ph.D||Florida State University|