Aerobic Training and Non-Exercise Physical Activity

NCT ID: NCT02010060

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-06-30

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.

Detailed Description

The Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN) study will investigate the effects of aerobic exercise training and increasing the amount of physical activity outside of training (Non-EX PA) on waist circumference, weight, and other cardiovascular disease risk factors in a prospective pilot trial. The investigators will randomize sedentary (<6,500 steps per day) obese adults with at least one additional cardiovascular risk factor (N= 45) to a: (1) structured aerobic exercise program with no intervention on Non-Ex PA (AERO group, N=15); (2) structured aerobic exercise program with the additional goal of increasing Non-EX PA (AERO-PA group, N=15), or (3) a non-exercise control group (CON, N=15) for 6 months. Exercise groups will participate in the same aerobic training program (50 to 75% VO2 max), designed to be consistent with public health recommendations of 150 minutes per week of moderate physical activity. Non-Ex PA in the AERO group will be tracked throughout the entire 6 month intervention with pedometers capable of counting steps, but not displaying them to the participant (blind mode capable). The AERO-PA group will progressively increase Non-Ex PA throughout intervention using pedometers (a progressive increase of 1,000 to 3,000 steps per day above baseline levels). The AERO-PA group will also participate in lifestyle counseling grounded in the principles of the behavioral change theories to determine/reinforce strategies to increase Non-Ex PA. The primary outcome measure will be change in waist circumference following the intervention. The results of this pilot study will be used to determine the efficacy/feasibility of the intervention, and power a larger trial as an R01 application.

Conditions

Central Obesity; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Aerobic Exercise Training

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

Group Type: EXPERIMENTAL

Aerobic Exercise Training

Intervention Type: 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+ Physical Activity

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

Group Type: EXPERIMENTAL

Aerobic Exercise+ Physical Activity

Intervention Type: 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

Interventions

Aerobic Exercise Training

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

Intervention Type: BEHAVIORAL

Aerobic Exercise+ Physical Activity

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

East Carolina University

OTHER

Sponsor Role: lead

Responsible Party

Damon Swift

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Damon L Swift, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

East Carolina University

Locations

East Carolina University

Greenville, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26542389 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33867498 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

13SDG17140091

Identifier Type: -

Identifier Source: org_study_id