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Low-intensity Resistance Exercise and Diet on Arterial Function and Blood Pressure

Primary Purpose

Obesity, Pre-hypertension, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance exercise training
Hypocaloric diet
Resistance exercise training & diet
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring low intensity resistance exercise training, hypocaloric diet, prehypertension, hypertension, obesity, arterial function, arterial stiffness, pulse wave velocity, autonomic function, endothelial function, adipocytokines

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female
  • 40 to 65 years of age
  • Body mass index of 27-39.9
  • Sedentary or low active (less than 2 hr per wk)

Exclusion Criteria:

  • Younger than 40 or older than 65 years of age
  • Body mass index lower than 27, or 40 or higher
  • Physically active or competitively active
  • Smoker
  • Systolic blood pressure higher than 140 mmHg
  • Use of hormone replacement therapy of less than 1 yr
  • Use of calcium channel blocker or beta blockers
  • Type 1 diabetes
  • Uncontrolled type 2 diabetes

Sites / Locations

  • Florida State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Resistance exercise training

Hypocaloric diet

Resistance exercise training & diet

Control

Arm Description

Lower-body exercises 3 times per wk for 12 wk

This arm involves 12 wk of the standard Nutrisystem foods plan complemented by fresh produce and dairy. Subjects consume breakfast, lunch, dinner, and one (women) or two (men) snacks per day.

Lower-body exercise training and diet

This arm involves not making any change to the subject's lifestyle at the moment of the start of the intervention and for 12 wk.

Outcomes

Primary Outcome Measures

Blood pressure
Non-invasive measures of brachial and aortic blood pressure

Secondary Outcome Measures

Autonomic Function
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
Endothelial Function
By measuring circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NO metabolites [NOx] and prostacyclin) and vasoconstrictors (endothelin-1 and prostaglandin F2α)
Body Composition
By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference
Arterial Stiffness
Using pulse wave velocity of the aorta, systemic, and legs
Pressure Wave Reflection
Using the augmentation index from radial tonometry

Full Information

First Posted
June 9, 2011
Last Updated
August 4, 2014
Sponsor
Florida State University
Collaborators
Nutrisystem, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01371370
Brief Title
Low-intensity Resistance Exercise and Diet on Arterial Function and Blood Pressure
Official Title
Effects of Low-intensity Resistance Exercise Training and Diet on Central Hemodynamics and Arterial Stiffness in Obese Middle-aged Women With High Blood Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
Nutrisystem, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Obesity is a major risk factor for premature arterial abnormalities including high blood pressure and increased stiffness. Previous studies have shown that weight loss via lifestyle modifications is associated with a decrease in large artery (aorta) stiffness. However, along with decreases in fat mass, hypocaloric diet reduces muscle mass. Low-intensity resistance exercise training (LIRET) results in similar increases in muscle mass and strength than those observed after high-intensity resistance exercise. The investigators hypothesis is that weight loss via diet combined with LIRET would additively reduce arterial stiffness and blood pressure (BP) in obese women. The investigators also hypothesize that the improved arterial function with weight loss would be associated with beneficial changes in the main mechanisms involved in BP regulation.
Detailed Description
The purpose of the study is to examine the effects of 12 weeks of low-intensity resistance exercise training (LIRET) and diet on arterial function, autonomic function, and body composition in obese women with high blood pressure (BP). Specific aims of the study are to: To evaluate the extent to which diet and LIRET will improve body composition assessed by changes in fat mass and lean mass using dual-energy x-ray absorptiometry and waist circumference. To investigate that combined diet and LIRET are more efficacious than either treatment alone in ameliorating cardiovascular disease risk factors by assessing arterial stiffness (aortic, systemic, and leg), aortic BP and wave reflection, and autonomic function (heart rate variability, vascular sympathetic activity [low-frequency power of systolic BP variability], and baroreflex sensitivity). Circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NO metabolites [NOx] and prostacyclin) and vasoconstrictors (endothelin-1 and prostaglandin F2α) will be assessed as secondary outcome variables.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pre-hypertension, Hypertension
Keywords
low intensity resistance exercise training, hypocaloric diet, prehypertension, hypertension, obesity, arterial function, arterial stiffness, pulse wave velocity, autonomic function, endothelial function, adipocytokines

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance exercise training
Arm Type
Experimental
Arm Description
Lower-body exercises 3 times per wk for 12 wk
Arm Title
Hypocaloric diet
Arm Type
Experimental
Arm Description
This arm involves 12 wk of the standard Nutrisystem foods plan complemented by fresh produce and dairy. Subjects consume breakfast, lunch, dinner, and one (women) or two (men) snacks per day.
Arm Title
Resistance exercise training & diet
Arm Type
Experimental
Arm Description
Lower-body exercise training and diet
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 12 wk.
Intervention Type
Other
Intervention Name(s)
Resistance exercise training
Intervention Description
The low intensity resistance exercise training intervention consists of lower-body resistance exercise (machines) 3 times per wk for 12 wk. Two sets the first 2 wk and 3 sets the rest of the intervention, at 40% of the estimated 1 repetition maximum, for 17 to 23 repetitions, with 1 minute of rest in between sets.
Intervention Type
Other
Intervention Name(s)
Hypocaloric diet
Intervention Description
The hypocaloric diet intervention consists of 12 wk of the standard Nutrisystem foods plan complemented by fresh produce and dairy. Subjects consume breakfast, lunch, dinner, and one (women) or two (men) snacks per day.
Intervention Type
Other
Intervention Name(s)
Resistance exercise training & diet
Intervention Description
Combination of low intensity resistance exercise training and hypocaloric diet
Primary Outcome Measure Information:
Title
Blood pressure
Description
Non-invasive measures of brachial and aortic blood pressure
Time Frame
12 weeks
Secondary Outcome Measure Information:
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
12 weeks
Title
Endothelial Function
Description
By measuring circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NO metabolites [NOx] and prostacyclin) and vasoconstrictors (endothelin-1 and prostaglandin F2α)
Time Frame
12 weeks
Title
Body Composition
Description
By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference
Time Frame
12 weeks
Title
Arterial Stiffness
Description
Using pulse wave velocity of the aorta, systemic, and legs
Time Frame
12 weeks
Title
Pressure Wave Reflection
Description
Using the augmentation index from radial tonometry
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female 40 to 65 years of age Body mass index of 27-39.9 Sedentary or low active (less than 2 hr per wk) Exclusion Criteria: Younger than 40 or older than 65 years of age Body mass index lower than 27, or 40 or higher Physically active or competitively active Smoker Systolic blood pressure higher than 140 mmHg Use of hormone replacement therapy of less than 1 yr Use of calcium channel blocker or beta blockers Type 1 diabetes Uncontrolled type 2 diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arturo Figueroa, M.D., Ph.D.
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23382493
Citation
Figueroa A, Vicil F, Sanchez-Gonzalez MA, Wong A, Ormsbee MJ, Hooshmand S, Daggy B. Effects of diet and/or low-intensity resistance exercise training on arterial stiffness, adiposity, and lean mass in obese postmenopausal women. Am J Hypertens. 2013 Mar;26(3):416-23. doi: 10.1093/ajh/hps050. Epub 2013 Jan 7.
Results Reference
derived

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Low-intensity Resistance Exercise and Diet on Arterial Function and Blood Pressure

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