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Trial record 1 of 13 for:    athis
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Army Training at High Intensity Study (ATHIS)

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ClinicalTrials.gov Identifier: NCT02407093
Recruitment Status : Completed
First Posted : April 2, 2015
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
National Development and Research Institutes, Inc.
Information provided by (Responsible Party):
Katie M. Heinrich, Kansas State University

Brief Summary:
Although soldiers must be ready to respond to occupational and war theatre demands at a moment's notice, there is an epidemic of overweight and obesity and a need for improved fitness and health in the military. Using a cluster randomized clinical trial we propose to test the effectiveness of a High-Intensity Functional Training (HIFT) exercise intervention to improve the body composition and fitness of active duty military personnel. The effectiveness of the HIFT intervention will be compared to usual Army Physical Readiness Training. Main outcomes will include changes in body composition and traditional fitness measures, a test of combat-preparation, and measures of cardiovascular health risk for both groups.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: High-Intensity Functional Training Behavioral: Army Physical Readiness Training Not Applicable

Detailed Description:

We will examine the effectiveness of a high-intensity functional training (HIFT) exercise intervention compared to Army Physical Readiness Training (APRT) and their related dietary instructions in improving body composition (percent body fat [%BF], fat mass, lean body mass, weight) and domains of Total Force Fitness (TFF; Army Physical Fitness Test [APFT], aerobic capacity, power, strength, and combat preparation and readiness) in a 6-month cluster-randomized clinical trial (CRCT) with 2 (+/- 1) month follow-up. We also will examine the effects of both exercise programs on cardiovascular disease (CVD) health risk (resting heart rate, blood pressure). We will conduct assessments at baseline, 6-months, and 2-month follow-up (+/- 1 month). We also will assess training time/volume, injuries, adverse events, adherence, and participant satisfaction and account for demographic and psychosocial variables.

In our CRCT, we aim to recruit and randomize approximately 150 soldiers (n=15 clusters-staff groups/platoons-per condition with at least 5 soldiers nested within each cluster) comparing the effectiveness of HIFT versus usual care (APRT) on:

Specific Aim 1 - changes in body composition including: percent body fat (%BF), fat mass, fat free mass, and body weight.

We hypothesize that soldiers in the HIFT condition will be significantly more likely to decrease a. %BF and b. fat mass, and to increase c. fat free mass than those in the APRT condition; we expect both groups to d. maintain body weight.

Specific Aim 2 - changes in fitness (e.g., APFT, power, strength), while accounting for actual physical training time in each condition.

We hypothesize that soldiers in the HIFT condition will have significantly greater improvement in their performance on fitness tests when compared to those in APRT, despite significantly less total training time. These outcomes will help determine if functional-oriented training can result in better fitness and combat preparedness for Army personnel.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HIFT for Obesity Prevention, Fitness and Health Promotion in Military Personnel
Actual Study Start Date : October 28, 2015
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-Intensity Functional Training
CrossFit will be the HIFT intervention framework with training elements, exercise programming, and scheduling set by CrossFit staff. Workouts will be comprised of one or more of three exercise modalities: aerobic/monostructural (e.g., running), gymnastics (e.g., pullups), and weightlifting/resistance training with workouts designed to maximize use of equipment available in deployed environments (e.g.,vehicle tires). All workouts will be individually scaled to each soldier's current level of fitness by a certified trainer. Sessions will be standardized across the 6 months of intervention so that each cluster will receive exactly the same training.
Behavioral: High-Intensity Functional Training
Constantly varied functional movements performed at a high intensity and incorporating monostructural (aerobic), gymnastics (body weight) and/or weightlifting movements. CrossFit is a good model of HIFT for the military because of its emphasis on general physical preparedness and functional movements and because it is open source and programming is available at no cost (see www.crossfit.com). Sixty-minute HIFT sessions will include a warm-up, workout and cool down. Workouts will average 15 minutes in duration (range = 5-45 minutes) for a total of 50-100 minutes per week.
Other Name: CrossFit

Active Comparator: Army Physical Readiness Training
The APRT program has combat readiness as the primary focus and is mandated for active duty personnel. For this study, APRT sessions have been standardized across the 6 months of the intervention according to FM 7-22 "Army Physical Readiness Training" manual so each cluster will receive the same training program using the Reset Phase. Sessions will consist of preparation, activities and recovery and will include strength, endurance, and mobility exercises that involve on-ground (e.g., running), off-ground (e.g., climbing), and combatives (e.g., striking and grappling) training, with supervision by a certified trainer.
Behavioral: Army Physical Readiness Training
Usual physical training program for Army personnel from directive FM 7-22, using the Reset phase. Exercises will address strength, endurance, and mobility training. APRT is designed to be completed in 60-90 minute sessions, 5 days/week for a total dose of 300-450 minutes per week.
Other Name: Army PT




Primary Outcome Measures :
  1. body fat percentage [ Time Frame: 6 months ]
    The Tanita 300 digital bioelectrical impedance/weight scale will be used to estimate body fat percentage.


Secondary Outcome Measures :
  1. aerobic capacity [ Time Frame: 6 months ]
    Aerobic capacity will be estimated from the time during the APFT 2-mile run.

  2. muscular power [ Time Frame: 6 months ]
    A standing horizontal jump will be used to assess power with the best of three attempts recorded.

  3. muscular strength [ Time Frame: 6 months ]
    We will assess participants' strength by determining their one repetition maximum (1RM) using the deadlift. Use of the 1RM test is a safe and reliable method of assessing strength in both trained and untrained subjects. The test procedure begins with a warm-up of 5-10 repetitions at 40% to 60% of the participant's estimated maximum. After a brief rest period, the load is increased to 60% to 80% of the participant's estimated maximum, attempting to complete 3-5 repetitions. At this point a small increase in weight is added to the load and a 1RM lift is attempted. The goal is to determine the participant's 1RM in 3 to 5 trials, allowing for ample rest (3-5 minutes) between each 1RM attempt.

  4. muscular endurance [ Time Frame: 6 months ]
    We will also assess upper body muscular endurance using the Marines pull-up test, where participants will complete as many consecutive strict pull-ups as possible before dropping off the bar.

  5. simulated victim rescue [ Time Frame: 6 months ]
    This test will simulate rescuing a wounded soldier on the battlefield. After a verbal signal, the participant will drag a 165-lb dummy 35-ft around a barrel and back 35-ft across the starting line for time.

  6. blood pressure [ Time Frame: 6 months ]
    An Omron BP785 10 series monitor will be used to assess blood pressure after the participant has been seated comfortably for at least 5 minutes.

  7. resting heart rate [ Time Frame: 6 months ]
    An Omron BP785 10 series monitor will be used to assess resting heart rate after the participant has been seated comfortably for at least 5 minutes.

  8. fat mass [ Time Frame: 6 months ]
    The Tanita 300 digital bioelectrical impedance/weight scale will be used to estimate fat mass

  9. fat free mass [ Time Frame: 6 months ]
    The Tanita 300 digital bioelectrical impedance/weight scale will be used to estimate fat free mass

  10. body mass index (BMI) [ Time Frame: 6 months ]
    Measured height (via stadiometer) and measured weight (via Tanita 300) will be used to calculate BMI

  11. waist circumference [ Time Frame: 6 months ]
    Waist circumference will be taken three times twice to the nearest 0.1 cm using standardized landmarks with a spring-loaded tape measure and will be used as a measure of central adiposity

  12. Army Physical Fitness Test (APFT) [ Time Frame: 6 months ]
    The APFT measures muscular and cardiorespiratory endurance and consists of 2 minutes of pushups, 2 minutes of sit-ups, and a 2 mile run with 10-20 minutes recovery between events.


Other Outcome Measures:
  1. training time [ Time Frame: 6 months ]
    Each participant will log each session completed during the 6-month intervention through the commercially available fitness software platform Beyond the Whiteboard (www.beyondthewhiteboard.com). The logs will be used to compute total time spent exercising and frequency of workouts.

  2. injury [ Time Frame: 6 months ]
    Injuries will be assessed by having participants report any injuries when they complete their daily log. Participants will provide the following information: injury date, body part, injury type, side, when it occurred, description, and the effect of the injury on their physical training status. Reported injuries will be automatically categorized as minor (e.g., bruise, skin tear), medium (e.g., dislocation, sprain/strain) or major (e.g., broken bone, cardiac event). Any medium or major injury will be automatically flagged in the system and both PIs will be immediately notified.

  3. dietary intake [ Time Frame: 6 months ]
    All participants will complete a food frequency questionnaire (FFQ) at baseline and 6 months. The Dietary Screener Questions for the National Health and Nutrition Examination Survey (NHANES) 2009-10, a validated self-administered monthly FFQ, will be used to monitor participants' dietary intakes. The 26 item food list has been amended to include 10 additional foods to more specifically capture intakes of meats, breads, pastas, eggs, nuts, and vegetables. The FFQ will be modified, scanned and frequencies of food intake calculated.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • physical activity clearance to participate in the study via the Physical Activity Readiness Questionnaire;
  • willingness to adhere to study protocol and complete all study assessments; and
  • high likelihood of assignment to the military post over the 8 (+/-) 1-month course of the study.

Exclusion Criteria:

  • being on permanent or temporary medical profile or having any medical condition or injury which would prevent participation in the exercise protocols;
  • having a pacemaker or other implanted/internal electrical device;
  • currently on administrative leave or assigned to exclusively administrative duties; and
  • (if female) pregnant or lactating, or planning to become pregnant in the next 9-months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407093


Locations
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United States, Kansas
Fort Leavenworth
Leavenworth, Kansas, United States, 66027
Kansas State University
Manhattan, Kansas, United States, 66506
Sponsors and Collaborators
Kansas State University
National Development and Research Institutes, Inc.
Investigators
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Principal Investigator: Katie M Heinrich, PhD Kansas State University
Principal Investigator: Walker SC Poston, PhD, MPH National Develop and Research Institutes
Publications:
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Responsible Party: Katie M. Heinrich, Associate Professor, Kansas State University
ClinicalTrials.gov Identifier: NCT02407093    
Other Study ID Numbers: 1R01DK099516-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Katie M. Heinrich, Kansas State University:
Body Composition
Military
High-Intensity Functional Training
Army Physical Fitness
CrossFit
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight