ObesityNCT01741766
The Effects of Stretching Training on Arterial Function and Autonomic Control
A study testing Stretching Training in people with Obesity and Pre-hypertension, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Pre-hypertension, Hypertension
- What is being tested?
- Stretching Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- Use of calcium channel blocker or beta blockers
- Type 1 diabetes
- Type 2 diabetes
- Known cardiovascular disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: The Effects of 8 Weeks of Stretching Training on Arterial Stiffness, Wave Reflection, Endothelial Function and Cardiac Autonomic Control.
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.
Read the 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)
- Conditions
- Obesity, Pre-hypertension, Hypertension
- Being tested
- Stretching Training
- Keywords
- prehypertension, hypertension, obesity, stretching, arterial function, arterial stiffness, pulse wave velocity, autonomic function, endothelial function
- Medical subject headings
- Obesity, Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching TrainingOther
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 group | Role | What they receive |
|---|---|---|
| Stretching Training | Experimental | Whole body stretching exercises 3 times per wk for 8 weeks Receives: Other: Stretching Training |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Non-invasive measures of brachial and aortic blood pressure
Measured: 8 weeks
Secondary outcomes (1)
Arterial Stiffness
Using pulse wave velocity of the aorta, systemic, and legs
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arturo Figueroa, Florida State University
- Investigators
- Arturo Figueroa, M.D., Ph.D, Study director, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741766
- Sponsor's protocol ID
- HSC2010.5615
- Status last verified
- Dec 2012
- First submitted
- 3 Dec 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 8 Weeks of Stretching Training on Arterial Stiffness, Wave Reflection, Endothelial Function and Cardiac Autonomic Control.
- ClinicalTrials.gov ID
- NCT01741766
- Acronym / sponsor ID
- HSC2010.5615
- Conditions
- Obesity, Pre-hypertension, Hypertension
- Keywords
- prehypertension, hypertension, obesity, stretching, arterial function, arterial stiffness, pulse wave velocity, autonomic function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching Training | Experimental | Other: Stretching TrainingWhole body stretching exercises 3 times per wk for 8 weeks |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stretching TrainingThe 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. | Other | Stretching Training |
Primary outcome
Blood pressure
Time frame: 8 weeks
Non-invasive measures of brachial and aortic blood pressure
1 secondary outcome
Arterial Stiffness
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arturo Figueroa, M.D., Ph.D study director
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching Training in people with Obesity and Pre-hypertension, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2012.