The Effects of Stretching Training on Arterial Function and Autonomic Control

• ClinicalTrials.gov Identifier: NCT01741766
• Recruitment Status: Completed
• First Posted: December 5, 2012
• Last Update Posted: December 5, 2012
• Sponsor: Florida State University
• Information provided by (Responsible Party): Arturo Figueroa, Florida State University

Tracking Information

• First Submitted Date: December 3, 2012
• First Posted Date: December 5, 2012
• Last Update Posted Date: December 5, 2012
• Study Start Date: May 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 4, 2012)

Blood pressure [ Time Frame: 8 weeks ]

Non-invasive measures of brachial and aortic blood pressure

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: December 4, 2012)

Arterial Stiffness [ Time Frame: 8 weeks ]

Using pulse wave velocity of the aorta, systemic, and legs

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: December 4, 2012)

• Autonomic Function [ Time Frame: 8 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
• Pressure Wave Reflection [ Time Frame: 8 weeks ]
  Using the augmentation index from radial tonometry

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: The Effects of Stretching Training on Arterial Function and Autonomic Control
• Official Title: 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.

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)

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science

Condition

• Obesity
• Pre-hypertension
• Hypertension

Intervention

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.

Study Arms

• Experimental: Stretching Training
  Whole body stretching exercises 3 times per wk for 8 weeks
  Intervention: Other: Stretching Training
• 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 8 wk.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 4, 2012): 30
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 50-65 years old
• Blood pressure between 121/81 and 159/99 mmHg
• Body mass index of 25-39.9
• Sedentary or low active (less than 2 hr per wk)

Exclusion Criteria:

• Younger than 50 or older than 65 years of age
• Body mass index lower than 25, or 40 or higher
• Physically active or competitively active
• Smoker
• Systolic blood pressure higher than 160 mmHg
• Use of hormone replacement therapy of less than 1 yr
• Use of calcium channel blocker or beta blockers
• Type 1 diabetes
• Type 2 diabetes
• Known cardiovascular disease

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01741766
• Other Study ID Numbers: HSC2010.5615
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Arturo Figueroa, Florida State University
• Study Sponsor: Florida State University
• Collaborators: Not Provided

Investigators

• Study Director: Arturo Figueroa, M.D., Ph.D; Florida State University

• PRS Account: Florida State University
• Verification Date: December 2012