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

This study has been completed.
Sponsor:
Collaborator:
Nutrisystem, Inc.
Information provided by (Responsible Party):
Arturo Figueroa, Florida State University
ClinicalTrials.gov Identifier:
NCT01371370
First received: June 9, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose
  • 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.

Condition Intervention
Obesity
Pre-hypertension
Hypertension
Other: Resistance exercise training
Other: Hypocaloric diet
Other: Resistance exercise training & diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Florida State University:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Non-invasive measures of brachial and aortic blood pressure


Secondary Outcome Measures:
  • Autonomic Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference

  • Arterial Stiffness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Using pulse wave velocity of the aorta, systemic, and legs

  • Pressure Wave Reflection [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Using the augmentation index from radial tonometry


Enrollment: 41
Study Start Date: December 2010
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resistance exercise training
Lower-body exercises 3 times per wk for 12 wk
Other: Resistance exercise training
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.
Experimental: Hypocaloric diet
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.
Other: Hypocaloric diet
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.
Experimental: Resistance exercise training & diet
Lower-body exercise training and diet
Other: Resistance exercise training & diet
Combination of low intensity resistance exercise training and hypocaloric diet
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 12 wk.

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.
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371370

Locations
United States, Florida
Florida State University
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University
Nutrisystem, Inc.
Investigators
Principal Investigator: Arturo Figueroa, M.D., Ph.D. Florida State University
  More Information

No publications provided by Florida State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arturo Figueroa, Associate Professor, Florida State University
ClinicalTrials.gov Identifier: NCT01371370     History of Changes
Other Study ID Numbers: 2011.5485
Study First Received: June 9, 2011
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Florida State University:
low intensity resistance exercise training
hypocaloric diet
prehypertension
hypertension
obesity
arterial function
arterial stiffness
pulse wave velocity
autonomic function
endothelial function
adipocytokines

Additional relevant MeSH terms:
Hypertension
Obesity
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014