- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02010060
Aerobic Training and Non-Exercise Physical Activity (I-CAN)
August 14, 2017 updated by: Damon Swift, East Carolina University
The Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Greenville, North Carolina, United States, 27858
- East Carolina University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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.
|
|
Experimental: 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
|
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
|
Experimental: 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in waist circumference
Time Frame: Baseline, 12 weeks, 24 weeks
|
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, 12 weeks, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cardiorespiratory fitness
Time Frame: Baseline and 24 weeks
|
Fitness will be measured using a modified Balke protocol on a treadmill.
Participants will walk at an initial speed of 2.0 mph with 0% grade for the first 3 minutes after which the treadmill speed will increase to 3.0 mph for the next 3 minutes.
The treadmill grade will be increased by 2.5% every 3 minutes until volitional exhaustion.
Respiratory gases (VO2, CO2) and ventilation will be measured continuously using a True Max 2400 Metabolic Measurement Cart (Parvomedics, Salt Lake City Utah).
|
Baseline and 24 weeks
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Change in body composition
Time Frame: Baseline and 24 weeks
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Dual-energy X-ray absorptiometry will be used to measure changes in fat and lean mass.
|
Baseline and 24 weeks
|
Change in dietary composition
Time Frame: Baseline and 24 weeks
|
Food Frequency Questionnaire (FFQ) contains approximately 105 items grouped by categories and is completed for both frequency of consumption as well as portion size selections by the individual.
The questionnaire, upon completion, provides estimated daily intake values for selected nutrients (kilocalories, macronutrients, and micronutrients) and provides information on food group servings.
|
Baseline and 24 weeks
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Change in body weight
Time Frame: Baseline, 12 weeks and 24 weeks
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Weight will be measured using a standardized scale
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Baseline, 12 weeks and 24 weeks
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Change in oral glucose tolerance (OGTT)
Time Frame: Baseline and 24 Weeks
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Insulin area under the curve (AUC) and glucose AUC will be determined from an oral glucose tolerance test
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Baseline and 24 Weeks
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Changes in physical activity levels
Time Frame: Baseline, 12 weeks and 24 Weeks
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Participants will wear a Sensewear accelerometer for seven consecutive days, 24-hrs/day.
The amount of time spent in sedentary, light and moderate to vigorous physical activity will be calculated
|
Baseline, 12 weeks and 24 Weeks
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Changes in blood lipids
Time Frame: Baseline and 24 weeks
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Low density lipoproteins, High density lipoproteins, total cholesterol, and triglycerides will be measured
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Baseline and 24 weeks
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Change in systemic inflammation
Time Frame: Baseline and 24 weeks
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high sensitivity c-reactive protein will be measured at baseline and follow-up
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Baseline and 24 weeks
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Change in oral glucose tolerance: Glucose and insulin AUC
Time Frame: Baseline and 24 Weeks
|
Glucose and insulin AUC will be measured following the injestion of 75 mg glucose solution at baseline and 24 weeks
|
Baseline and 24 Weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
December 5, 2013
First Submitted That Met QC Criteria
December 9, 2013
First Posted (Estimate)
December 12, 2013
Study Record Updates
Last Update Posted (Actual)
August 16, 2017
Last Update Submitted That Met QC Criteria
August 14, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13SDG17140091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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