The Effects of Stretching Training on Arterial Function and Autonomic Control
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ClinicalTrials.gov Identifier: NCT01741766 |
Recruitment Status :
Completed
First Posted : December 5, 2012
Last Update Posted : December 5, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | December 3, 2012 | |||
First Posted Date ICMJE | December 5, 2012 | |||
Last Update Posted Date | December 5, 2012 | |||
Study Start Date ICMJE | May 2011 | |||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Blood pressure [ Time Frame: 8 weeks ] Non-invasive measures of brachial and aortic blood pressure
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
Arterial Stiffness [ Time Frame: 8 weeks ] Using pulse wave velocity of the aorta, systemic, and legs
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | |||
Descriptive Information | ||||
Brief Title ICMJE | The Effects of Stretching Training on Arterial Function and Autonomic Control | |||
Official Title ICMJE | The Effects of 8 Weeks of Stretching Training on Arterial Stiffness, Wave Reflection, Endothelial Function and Cardiac Autonomic Control. | |||
Brief Summary | Hypertension is a major risk factor for cardiovascular disease. Hypertension and abdominal obesity are associated with dysfunction of the main mechanisms of cardiovascular regulation, the autonomic nervous system and the vascular endothelium. Increased sympathetic activity and endothelial dysfunction are associated with increased arterial stiffness, which is an independent risk factor for the development of hypertension and other cardiovascular diseases. The recommended intervention for controlling BP in pre- and stage 1- hypertensive individuals is lifestyle modifications such as exercise, and not drug therapy.Although aerobic and resistance exercise has been shown to be beneficial for the cardiovascular system, special populations such as the elderly and obese may have physical and/or musculoskeletal limitations which may limit their participation in these exercise modalities. Stretching is a form of exercise that is widely recommended for injury prevention. Among the benefits of stretching are an increased flexibility, enhanced muscular coordination, stress relief, improved range of motion and an improved posture. Previous studies have shown stretching training to increase arterial compliance and acutely increase sympathetic nerve activity. In addition, low flexibility levels have been found to be associated with arterial stiffness. Given that stretching of skeletal muscle causes an increase in sympathetic nerve activity; repetitive stimulation of sympathetic activity induced by habitual stretching, might chronically reduce resting sympathetic activity. The reduction in sympathetic activity might result in a decrease of arterial stiffness and blood pressure. The investigators hypothesis is that 8 weeks of stretching training would reduce arterial stiffness, blood pressure and sympathetic activity in obese women. The investigators also hypothesize that the improved arterial function with stretching would be associated with increases in flexibility levels. |
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Detailed Description | The purpose of this study is to examine the effects of 8 weeks of stretching training on blood pressure,arterial stiffness, wave reflection, endothelial function and cardiovascular autonomic control. The specific aim of the study is: - To evaluate the effects of 8 weeks of ST on arterial function and aortic hemodynamics by assessing arterial stiffness (aortic, systemic, and leg), aortic blood pressure and wave reflection, and autonomic function (heart rate variability, vascular sympathetic activity [low-frequency power of systolic BP variability], and baroreflex sensitivity) |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE |
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Intervention ICMJE | Other: Stretching Training
The stretching training intervention consists of 38 whole-body stretching exercises, 3 times per week for 8 wk. Each stretch will be held in place for 30 seconds, with a 15 seconds of rest in between stretches.
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
30 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2011 | |||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01741766 | |||
Other Study ID Numbers ICMJE | HSC2010.5615 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Arturo Figueroa, Florida State University | |||
Study Sponsor ICMJE | Florida State University | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Florida State University | |||
Verification Date | December 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |