NCT02407093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

October 28, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

3.7 years

First QC Date

March 30, 2015

Last Update Submit

November 11, 2020

Conditions

Obesity

Keywords

Body CompositionMilitaryHigh-Intensity Functional TrainingArmy Physical FitnessCrossFit

Outcome Measures

Primary Outcomes (1)

  • body fat percentage

    The Tanita 300 digital bioelectrical impedance/weight scale will be used to estimate body fat percentage.

    6 months

Secondary Outcomes (12)

  • aerobic capacity

    6 months

  • muscular power

    6 months

  • muscular strength

    6 months

  • muscular endurance

    6 months

  • simulated victim rescue

    6 months

  • +7 more secondary outcomes

Other Outcomes (3)

  • training time

    6 months

  • injury

    6 months

  • dietary intake

    6 months

Study Arms (2)

High-Intensity Functional Training

EXPERIMENTAL

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

Army Physical Readiness Training

ACTIVE COMPARATOR

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

Interventions

High-Intensity Functional TrainingBEHAVIORAL

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.

Also known as: CrossFit
High-Intensity Functional Training
Army Physical Readiness TrainingBEHAVIORAL

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.

Also known as: Army PT
Army Physical Readiness Training

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fort Leavenworth

Leavenworth, Kansas, 66027, United States

Location

Kansas State University

Manhattan, Kansas, 66506, United States

Location

Related Publications (4)

  • Poston WS, Haddock CK, Heinrich KM, Jahnke SA, Jitnarin N, Batchelor DB. Is High-Intensity Functional Training (HIFT)/CrossFit Safe for Military Fitness Training? Mil Med. 2016 Jul;181(7):627-37. doi: 10.7205/MILMED-D-15-00273.

    PMID: 27391615BACKGROUND

  • Haddock CK, Poston WS, Heinrich KM, Jahnke SA, Jitnarin N. The Benefits of High-Intensity Functional Training Fitness Programs for Military Personnel. Mil Med. 2016 Nov;181(11):e1508-e1514. doi: 10.7205/MILMED-D-15-00503.

    PMID: 27849484BACKGROUND

  • Poston WS, Haddock CK, Heinrich KM, Jahnke SA, Jitnarin N, Batchelor DB, Feito Y, Suminski RR. Response: Is High-Intensity Functional Training (HIFT)/CrossFit Safe for Military Fitness Training? Mil Med. 2017 Jan;182(1):1476-1479. doi: 10.7205/MILMED-D-16-00369. No abstract available.

    PMID: 28051964BACKGROUND

  • Feito Y, Heinrich KM, Butcher SJ, Poston WSC. High-Intensity Functional Training (HIFT): Definition and Research Implications for Improved Fitness. Sports (Basel). 2018 Aug 7;6(3):76. doi: 10.3390/sports6030076.

    PMID: 30087252BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Katie M Heinrich, PhD

    Kansas State University

    PRINCIPAL INVESTIGATOR

  • Walker SC Poston, PhD, MPH

    National Develop and Research Institutes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 2, 2015

Study Start

October 28, 2015

Primary Completion

June 28, 2019

Study Completion

June 28, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)