The Effects of Stretching Training on Arterial Function and Autonomic Control
Primary Purpose
Obesity, Pre-hypertension, Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stretching Training
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring prehypertension, hypertension, obesity, stretching, arterial function, arterial stiffness, pulse wave velocity, autonomic function, endothelial function
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
Sites / Locations
- Florida State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Stretching Training
Control
Arm Description
Whole body stretching exercises 3 times per wk for 8 weeks
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.
Outcomes
Primary Outcome Measures
Blood pressure
Non-invasive measures of brachial and aortic blood pressure
Secondary Outcome Measures
Arterial Stiffness
Using pulse wave velocity of the aorta, systemic, and legs
Full Information
NCT ID
NCT01741766
First Posted
December 3, 2012
Last Updated
December 4, 2012
Sponsor
Florida State University
1. Study Identification
Unique Protocol Identification Number
NCT01741766
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pre-hypertension, Hypertension
Keywords
prehypertension, hypertension, obesity, stretching, arterial function, arterial stiffness, pulse wave velocity, autonomic function, endothelial function
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stretching Training
Arm Type
Experimental
Arm Description
Whole body stretching exercises 3 times per wk for 8 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Stretching Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood pressure
Description
Non-invasive measures of brachial and aortic blood pressure
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Arterial Stiffness
Description
Using pulse wave velocity of the aorta, systemic, and legs
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Autonomic Function
Description
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
Time Frame
8 weeks
Title
Pressure Wave Reflection
Description
Using the augmentation index from radial tonometry
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arturo Figueroa, M.D., Ph.D
Organizational Affiliation
Florida State University
Official's Role
Study Director
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
12. IPD Sharing Statement
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The Effects of Stretching Training on Arterial Function and Autonomic Control
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