Aerobic Training and Non-Exercise Physical Activity

NCT02010060 | Completed Results

• 1 other identifier: 13SDG17140091
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the health benefits of combining exercise training and increasing the amount of physical activity in daily life on the fat around the abdomen, weight, fitness and sensitivity to insulin. Volunteers will participate in one of three groups for 6 months: 1) a control group, 2) exercise training only, or 3) exercise training and increasing physical activity outside of training. The exercise training will follow the public health recommendations for exercise (150 minutes/week of moderate exercise). The group increasing physical activity along with exercise training will be asked to increase physical activity in their daily life (up to 3,000 step/day above their current levels through the use of step counters), and meetings focused on behavior modification. The investigators hypothesize that combining aerobic training and additional physical activity after training will have the most profound reduction on waist circumference and body composition.

Conditions

Central Obesity; Obesity

Keywords

Exercise training; Non-exercise physical activity; pedometers

Outcome Measures

Primary Outcomes (1)

• Change in Waist Circumference

  Waist circumference will be measured at the natural waist (midway between the inferior border of the rib cage and the superior aspect of the iliac crest) with a Gulick tape measure. Both landmarks (the inferior border of the ribcage and the superior aspect of the iliac crest) will be marked and the distance will be measured to determine the appropriate measurement site. Staff will confirm that: 1) the measurement tape remains horizontal; 2) the tape touches the entire circumference of the participant; 3) abdominal tissue is not compressed; 3) the tape measure is not within abdominal folds; 4) the measurement is taken at the end of normal respiration. The measurement will be repeated an additional time, and the reported value will be the average of these measurements. Both measurements must be within 0.5 cm to be considered acceptable for data purposes.

  Baseline and 24 weeks

Secondary Outcomes (13)

• Change in Body Fat

  Baseline to 24 weeks

• Change in Body Weight

  Baseline and 24 weeks

• Change in Cardiorespiratory Fitness (L/Min)

  Baseline and 24 weeks

• Change in Insulin Sensitivity

  Baseline and 24 Weeks

• Change in Low Density Lipoprotein (LDL)

  Baseline and 24 weeks

Study Arms (3)

Control

NO INTERVENTION

The goal of this group is to maintain their current lifestyle habits during the intervention. participants are asked to make no conscious changes to their physical activity or dietary habits.

Aerobic Exercise Training

EXPERIMENTAL

The Aerobic training group will participate in 6 months of aerobic training and asked to make no conscious alterations in their physical activity outside of exercise session, or dietary habits

Behavioral: Aerobic Exercise Training

Aerobic Exercise+ Physical Activity

EXPERIMENTAL

The goal of this group is to perform 6 months of aerobic exercise and increase the amount of physical activity outside of their training sessions. They will be asked to make no conscious changes to their dietary habits

Behavioral: Aerobic Exercise+ Physical Activity

Interventions

Aerobic Exercise Training BEHAVIORAL

Individuals randomized to the aerobic exercise training group will participate in 6 months of supervised exercise training. Exercise dose (expressed in kilocalories per kg per week \[KKW\]) during aerobic training will be 8KKW in week 1, 10KKW in week 2 and 12 KKW in week 3. the exercise dose of 12KKW will be maintained throughout the intervention. Pedometers will be worn by participant in blind-mode throughout the intervention, and removed during exercise training sessions. Participants will enter information about whether they wore their pedometer on the study website. Aerobic exercise group participants will be told to make no conscious alterations to their physical activity or dietary habits

Aerobic Exercise Training

Aerobic Exercise+ Physical Activity BEHAVIORAL

The Aerobic Exercise+ Physical Activity Group will participate in the same supervised exercise training intervention as the Aerobic Exercise Group, but will also increase the amount of non-exercise physical activity in their daily lives. After week 6 of intervention, participants will incrementally increase Non-Ex PA until they reach an average of 3,000 steps/day above baseline. Non-Ex PA will be increased with moderate physical activity consistent with daily living (i.e. leisurely walking in the evening, walking the dog etc.). Participants will also periodically have life-style counseling sessions with instructors with expertise in behavioral change support to their dietary habits

Aerobic Exercise+ Physical Activity

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 40 to 65 years
• Body mass index: 30-40
• Sedentary status
• One additional risk factor for cardiovascular disease
• High waist circumference

You may not qualify if:

• Previous heart attack or stroke
• Type 1 or type 2 diabetes
• Resting systolic blood pressure \>180 mmHg
• Resting diastolic blood pressure\>100 mmHg
• Plans to be away from the Pitt County area more than 4 weeks in the next 6 months
• Currently pregnant or plans to become pregnant
• Not full-filling requirements during the screening process
• Currently using weight loss medications
• Gastric banding surgery

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27858, United States

Location

Related Publications (2)

• Swift DL, Dover SE, Nevels TR, Solar CA, Brophy PM, Hall TR, Houmard JA, Lutes LD. The intervention composed of aerobic training and non-exercise physical activity (I-CAN) study: Rationale, design and methods. Contemp Clin Trials. 2015 Nov;45(Pt B):435-442. doi: 10.1016/j.cct.2015.11.005. Epub 2015 Nov 2.

  PMID: 26542389 BACKGROUND

• Swift DL, Nevels TR, Solar CA, Brophy PM, McGee JE, Brewer SB, Clark A, Houmard JA, Lutes LD. The Effect of Aerobic Training and Increasing Nonexercise Physical Activity on Cardiometabolic Risk Factors. Med Sci Sports Exerc. 2021 Oct 1;53(10):2152-2163. doi: 10.1249/MSS.0000000000002675.

  PMID: 33867498 DERIVED

MeSH Terms

Conditions

Obesity, Abdominal; Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Damon Swift
• Organization: University of Virginia

dls3s@virginia.edu

(434) 924-1436

Study Officials

• Damon L Swift, Ph.D.

  East Carolina University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 12, 2013
• Study Start: February 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 31, 2024
• Results First Posted: October 31, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)