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

NCT01371370 | Completed

• 1 other identifier: 2011.5485
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  Non-invasive measures of brachial and aortic blood pressure

  12 weeks

Secondary Outcomes (5)

• Autonomic Function

  12 weeks

• Endothelial Function

  12 weeks

• Body Composition

  12 weeks

• Arterial Stiffness

  12 weeks

• Pressure Wave Reflection

  12 weeks

Study Arms (4)

Resistance exercise training

EXPERIMENTAL

Lower-body exercises 3 times per wk for 12 wk

Other: Resistance exercise training

Hypocaloric diet

EXPERIMENTAL

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

Resistance exercise training & diet

EXPERIMENTAL

Lower-body exercise training and diet

Other: Resistance exercise training & diet

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 12 wk.

Interventions

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.

Resistance exercise training

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.

Hypocaloric diet

Resistance exercise training & diet OTHER

Combination of low intensity resistance exercise training and hypocaloric diet

Resistance exercise training & diet

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead
• Nutrisystem, Inc.: collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Publications (1)

• 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.

  PMID: 23382493 DERIVED

MeSH Terms

Conditions

Obesity; Prehypertension; Hypertension

Interventions

Resistance Training; Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Arturo Figueroa, M.D., Ph.D.

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 10, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: August 5, 2014

Record last verified: 2014-08

Locations

US (1)