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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02185872
Other study ID # #6058
Secondary ID
Status Completed
Phase N/A
First received July 3, 2014
Last updated March 30, 2015
Start date February 2012
Est. completion date May 2012

Study information

Verified date March 2015
Source Kansas State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study was to examine the differences in glucose control, fitness, and body composition between a standard aerobic and resistance exercise training program and a shorter-duration, high-intensity CrossFit training program in overweight and obese physically inactive adults.

Hypotheses:

1. Both groups would improve glucose control, with the CrossFit group improving significantly more than the aerobic and resistance training group.

2. Both groups would improve fitness, with the CrossFit group improving significantly more than the aerobic and resistance training group.

3. Both groups would demonstrate decreases in body fat percentage and fat mass and increases in lean body mass, with the CrossFit group improving significantly more than the aerobic and resistance training group.


Description:

Overweight or obese participants will take part in an 8-week exercise intervention after clearance from a doctor, that is expected to improve glucose control, fitness (Eurofit and peak aerobic capacity), and body composition (body fat percentage, fat mass, and lean body mass). After stratification by age and body mass index, participants will be randomized to either a standard aerobic and resistance training exercise program or a relatively higher intensity, shorter duration CrossFit exercise program.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- body mass index (BMI) of 25 - < 40, physically inactive (i.e., not participating in any structured exercise programs for the past 2 months and not exceeding 30 total minutes of physical activity per week)

Exclusion Criteria:

- current smoker, pregnant, taking blood glucose altering medications, heart disease, type 1 or 2 diabetes mellitus, total cholesterol 200 mg/dL or higher

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
High-Intensity Functional Training
Participants were instructed to work as hard as they could while maintaining safe technique and proper form to achieve as many reps or rounds as possible in the prescribed time frame. As HIFT participants became accustomed to specific movements, less time was dedicated to practicing movements and technique.
Aerobic and Resistance Training
The protocol was based upon current guidelines of 150 minutes moderate-intensity aerobic activity and 2 days of muscle strengthening per week.

Locations

Country Name City State
United States Kansas State University Manhattan Kansas

Sponsors (1)

Lead Sponsor Collaborator
Kansas State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Heinrich KM, Patel PM, O'Neal JL, Heinrich BS. High-intensity compared to moderate-intensity training for exercise initiation, enjoyment, adherence, and intentions: an intervention study. BMC Public Health. 2014 Aug 3;14:789. doi: 10.1186/1471-2458-14-789 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Time spent completing daily workouts Time spent to complete each assigned daily workout was individually recorded for each participant 24 exercise sessions over 8 weeks No
Primary Change from baseline in glucose control. Fasting plasma glucose levels were taken after an overnight fast of at least 8 hours. An oral glucose tolerance test was conducted after ingestion of a 75g oral dextrose solution with finger sticks at 30, 45, and 60 minutes from time 0. The following equation was used to calculate glucose area under the curve which was the metric utilized to ascertain changes in glucose control: [(Time 45 - Time 30) * ½ (OGTT 30 + OGTT 45)] + [(Time 60 - Time 45) * ½ (OGTT 60 + OGTT 45)] Baseline, Week 10 No
Secondary Change from baseline in peak aerobic capacity Modified Balke protocol Baseline, Week 10 No
Secondary Change from baseline in sit and reach Eurofit protocol for sit and reach distance using flex tester box Baseline, Week 10 No
Secondary Change from baseline in standing broad jump Eurofit protocol Baseline, Week 10 No
Secondary Change from baseline in vertical jump Eurofit protocol Baseline, Week 10 No
Secondary Change from baseline in pushups Eurofit protocol; completed on feet or knees Baseline, Week 10 No
Secondary Change from baseline in situps Eurofit protocol Baseline, Week 10 No
Secondary Change from baseline in 40 meter dash A handheld stopwatch was used to record time from the command "Go" until the participant crossed the line at 40 meters Baseline, Week 10 No
Secondary Change from baseline in stork balance test Baseline, Week 10 No
Secondary Change from baseline in body composition Dual X-ray absorptiometry scan was used to assess body fat percentage, lean body mass, and fat mass. Baseline, Week 12 No
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