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NCT Number: NCT01371370

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

* 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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Hypertension Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pre-Hypertension Prehypertension Signs and Symptoms Vascular Diseases

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance Exercise Training

Other

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.

Hypocaloric diet

Other

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.

Resistance exercise training & diet

Other

Combination of low intensity resistance exercise training and hypocaloric diet

Primary outcomes

  1. Blood pressure

    Time frame: 12 weeks

    Non-invasive measures of brachial and aortic blood pressure

Secondary outcomes

  1. Autonomic Function

    Time frame: 12 weeks

    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

  2. Endothelial Function

    Time frame: 12 weeks

    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)

  3. Body Composition

    Time frame: 12 weeks

    By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference

  4. Arterial Stiffness

    Time frame: 12 weeks

    Using pulse wave velocity of the aorta, systemic, and legs

  5. Pressure Wave Reflection

    Time frame: 12 weeks

    Using the augmentation index from radial tonometry

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Nutrisystem, Inc.

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 10, 2011
Registry last updated
Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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