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

NCT ID: NCT01371370

Last Updated: 2014-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-06-30

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.

Conditions

Obesity; Pre-hypertension; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Resistance exercise training

Lower-body exercises 3 times per wk for 12 wk

Group Type: EXPERIMENTAL

Resistance exercise training

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Hypocaloric diet

Intervention Type: 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

Lower-body exercise training and diet

Group Type: EXPERIMENTAL

Resistance exercise training & diet

Intervention Type: OTHER

Combination of low intensity resistance exercise training and hypocaloric diet

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Resistance exercise training & diet

Combination of low intensity resistance exercise training and hypocaloric diet

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nutrisystem, Inc.

INDUSTRY

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Arturo Figueroa

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arturo Figueroa, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Florida State University

Tallahassee, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23382493 (View on PubMed)

Other Identifiers

2011.5485

Identifier Type: -

Identifier Source: org_study_id