NCT01741766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

7 months

First QC Date

December 3, 2012

Last Update Submit

December 4, 2012

Conditions

ObesityPre-hypertensionHypertension

Keywords

prehypertensionhypertensionobesitystretchingarterial functionarterial stiffnesspulse wave velocityautonomic functionendothelial function

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Non-invasive measures of brachial and aortic blood pressure

    8 weeks

Secondary Outcomes (1)

  • Arterial Stiffness

    8 weeks

Other Outcomes (2)

  • Autonomic Function

    8 weeks

  • Pressure Wave Reflection

    8 weeks

Study Arms (2)

Stretching Training

EXPERIMENTAL

Whole body stretching exercises 3 times per wk for 8 weeks

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.

Interventions

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.

Stretching Training

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

ObesityPrehypertensionHypertension

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • Arturo Figueroa, M.D., Ph.D

    Florida State University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 5, 2012

Study Start

May 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

US(1)