HyperglycemiaNCT02185872
CrossFit Exercise to Improve Glucose Control for Overweight and Obese Adults
A study testing High-Intensity Functional Training and Aerobic and Resistance Training in people with Hyperglycemia, run by Kansas State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- High-Intensity Functional Training and Aerobic and Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- current smoker, pregnant, taking blood glucose altering medications, heart disease, type 1 or 2 diabetes mellitus, total cholesterol 200 mg/dL or higher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of a CrossFit Exercise Program on Glucose Control in Overweight and Obese Individuals
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:
- Both groups would improve glucose control, with the CrossFit group improving significantly more than the aerobic and resistance training group.
- Both groups would improve fitness, with the CrossFit group improving significantly more than the aerobic and resistance training group.
- 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.
Read the detailed 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.
- Conditions
- Hyperglycemia
- Being tested
- High-Intensity Functional Training, Aerobic and Resistance Training
- Keywords
- Exercise, Physical Fitness, Body Composition, Beneficial
- Medical subject headings
- Hyperglycemia, Motor Activity, Glucocorticoid Receptor Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Functional TrainingOther
Also called CrossFit
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 TrainingOther
The protocol was based upon current guidelines of 150 minutes moderate-intensity aerobic activity and 2 days of muscle strengthening per week.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic and Resistance Training | Active comparator | Participants completed 24 exercise sessions based on current guidelines. Aerobic exercise (50 min) was performed on machines every session and resistance training (20 min) was performed on machines two sessions per week. Aerobic intensity was prescribed at 40-50% of heart rate reserve (HRR) Weeks 1-4 and 50-60% HRR Weeks 5-8. Resistance training was supervised by an ACE certified personal trainer. One-repetition maximums (1-RM) were assessed Week 1 (i.e., seated bicep curl, military press, seated lat pulldown, seated leg extension, triceps pulldown, bench press, reverse leg curl, seated leg press). For Weeks 2-3 participants completed, 3 sets of 15 reps at 50% 1-RM; Weeks 4-5, 3 sets of 12 reps at 60% 1-RM; Weeks 6-7, 3 sets of 10 reps at 70% 1-RM; Week 8, 3 sets of 8 reps at 75% 1-RM. Three sets of 15 unweighted crunches were completed each day. One minute of rest was taken between each set and each exercise. Receives: Other: Aerobic and Resistance Training |
| High-intensity functional training | Experimental | Participants completed a total of 24 sessions that were pre-programmed and led by a certified instructor (CrossFit Level 2), which lasted up to 60 minutes in duration. The first two class periods were structured as an introduction to common movements used in high-intensity functional training (HIFT; e.g., squats, deadlift, press, jerks, barbell, dumbbell, and medicine ball cleans, pullups, kettlebell swings, among others). No scheduled workouts were given on days 1 and 2. Beginning on day 3 each HIFT class consisted of 10-15 minutes of stretching and warmup, 10-20 minutes of instruction and practicing techniques and movements, and 5-30 minutes for the workout of the day, performed at vigorous intensity, relative to each person's ability and fitness level. All weights and movements were individually prescribed and recorded for each participant. Receives: Other: High-Intensity Functional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)]
Measured: Baseline, Week 10
Secondary outcomes (9)
Change from baseline in peak aerobic capacity
Modified Balke protocol
Measured: Baseline, Week 10
Change from baseline in sit and reach
Eurofit protocol for sit and reach distance using flex tester box
Measured: Baseline, Week 10
Change from baseline in standing broad jump
Eurofit protocol
Measured: Baseline, Week 10
Change from baseline in vertical jump
Eurofit protocol
Measured: Baseline, Week 10
Change from baseline in pushups
Eurofit protocol; completed on feet or knees
Measured: Baseline, Week 10
Change from baseline in situps
Eurofit protocol
Measured: Baseline, Week 10
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
Measured: Baseline, Week 10
Change from baseline in stork balance test
Measured: Baseline, Week 10
Change from baseline in body composition
Dual X-ray absorptiometry scan was used to assess body fat percentage, lean body mass, and fat mass.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie M. Heinrich, Kansas State University
- Investigators
- Katie M Heinrich, PhD, Principal investigator, Kansas State UniversityPratik Patel, MS, RD, Study director, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185872
- Sponsor's protocol ID
- #6058
- Status last verified
- Mar 2015
- First submitted
- 3 Jul 2014
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25086646
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a CrossFit Exercise Program on Glucose Control in Overweight and Obese Individuals
- ClinicalTrials.gov ID
- NCT02185872
- Acronym / sponsor ID
- #6058
- Conditions
- Hyperglycemia
- Keywords
- Exercise, Physical Fitness, Body Composition, Beneficial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Both groups would improve glucose control, with the CrossFit group improving significantly more than the aerobic and resistance training group.
- Both groups would improve fitness, with the CrossFit group improving significantly more than the aerobic and resistance training group.
- 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic and Resistance Training | Active comparator | Other: Aerobic and Resistance TrainingParticipants completed 24 exercise sessions based on current guidelines. Aerobic exercise (50 min) was performed on machines every session and resistance training (20 min) was performed on machines two sessions per week. Aerobic intensity was prescribed at 40-50% of heart rate reserve (HRR) Weeks 1-4 and 50-60% HRR Weeks 5-8. Resistance training was supervised by an ACE certified personal trainer. One-repetition maximums (1-RM) were assessed Week 1 (i.e., seated bicep curl, military press, seated lat pulldown, seated leg extension, triceps pulldown, bench press, reverse leg curl, seated leg press). For Weeks 2-3 participants completed, 3 sets of 15 reps at 50% 1-RM; Weeks 4-5, 3 sets of 12 reps at 60% 1-RM; Weeks 6-7, 3 sets of 10 reps at 70% 1-RM; Week 8, 3 sets of 8 reps at 75% 1-RM. Three sets of 15 unweighted crunches were completed each day. One minute of rest was taken between each set and each exercise. |
| High-intensity functional training | Experimental | Other: High-Intensity Functional TrainingParticipants completed a total of 24 sessions that were pre-programmed and led by a certified instructor (CrossFit Level 2), which lasted up to 60 minutes in duration. The first two class periods were structured as an introduction to common movements used in high-intensity functional training (HIFT; e.g., squats, deadlift, press, jerks, barbell, dumbbell, and medicine ball cleans, pullups, kettlebell swings, among others). No scheduled workouts were given on days 1 and 2. Beginning on day 3 each HIFT class consisted of 10-15 minutes of stretching and warmup, 10-20 minutes of instruction and practicing techniques and movements, and 5-30 minutes for the workout of the day, performed at vigorous intensity, relative to each person's ability and fitness level. All weights and movements were individually prescribed and recorded for each participant. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- current smoker, pregnant, taking blood glucose altering medications, heart disease, type 1 or 2 diabetes mellitus, total cholesterol 200 mg/dL or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Functional TrainingAlso: CrossFitParticipants 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. | Other | High-intensity functional training |
| Aerobic and Resistance TrainingThe protocol was based upon current guidelines of 150 minutes moderate-intensity aerobic activity and 2 days of muscle strengthening per week. | Other | Aerobic and Resistance Training |
Primary outcome
Change from baseline in glucose control.
Time frame: Baseline, Week 10
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)]
9 secondary outcomes
Change from baseline in peak aerobic capacity
Time frame: Baseline, Week 10
Change from baseline in sit and reach
Time frame: Baseline, Week 10
Change from baseline in standing broad jump
Time frame: Baseline, Week 10
Change from baseline in vertical jump
Time frame: Baseline, Week 10
Change from baseline in pushups
Time frame: Baseline, Week 10
Change from baseline in situps
Time frame: Baseline, Week 10
Change from baseline in 40 meter dash
Time frame: Baseline, Week 10
Change from baseline in stork balance test
Time frame: Baseline, Week 10
Change from baseline in body composition
Time frame: Baseline, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Results publication: PubMed 25086646Heinrich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie M Heinrich, PhD principal investigator
Kansas State University
Pratik Patel, MS, RD study director
Kansas State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Functional Training and Aerobic and Resistance Training in people with Hyperglycemia, run by Kansas State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in glucose control. (time frame: Baseline, Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02185872, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.