Clinical trial NCT05003778: Minimal Equipment Training Approach to Improve Warfighter Performance
Official title: The Effects of a Minimal Equipment Training Approach Compared to Concurrent Training to Improve Warfighter Health and Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Military Operations
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2021-08-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to compare a minimal equipment training program with and without blood flow restriction (BFR) training to periodized concurrent resistance and endurance training. The outcomes of interest are Army Combat Fitness Test (ACFT) performance along with laboratory measures of performance, which include body composition, power, strength, and maximal aerobic capacity (VO2max). Additionally, based on the role of mechanical tension in connective tissue adaptation and the importance for chronic musculoskeletal health, tendon architecture will be assessed as well. Lastly, specific blood-based biomarkers will be analyzed in conjunction with questionnaires to determine the systemic physiological and psychological responses to training. Participants will be randomized into one of three training groups and will follow their respective program for 6 weeks. The three groups are traditional concurrent resistance and endurance training, minimal equipment training, and minimal equipment training with blood flow restriction (BFR).

Detailed description: The efficacy of minimal equipment training programs with an emphasis on resistance training has seldom been assessed and compared to traditional strength training. Common training strategies include traditional high-to-moderate load resistance training and low-to-moderate load field training using minimal equipment. The benefit of traditional CT is likely due to the higher loads relative to 1-repetition maximum (1RM) utilized and overall amount of mechanical stress incurred. It is difficult to mimic this loading with minimal equipment training, which is often performed at low loads relative to 1RM. However, one strategy to improve the effectiveness of minimal equipment training may be the addition of blood flow restriction (BFR) training. Due to the relatively low loads (20-70% 1RM) of minimal equipment training, BFR training not only provides athletes with a novel training modality to elicit hypertrophic and strength adaptation but also to augment recovery as a supplemental low-damage, high-volume training method. The research design will allow for the direct comparison of minimal equipment training with and without additional BFR training to periodized CT with regard to changes in outcomes, in particular, ACFT performance.

Eligibility criteria: Inclusion Criteria:

* Males and females between the ages of 18 and 35 (inclusive) and enrolled in an ROTC program.
* Subject has provided written and dated informed consent to participate in the study.
* Subject is in good health as determined by medical history and is cleared for exercise.
* Subject will be asked about dietary supplementation use within the past 6 months.

  * If subject began taking a supplement within the past month, subject will be asked to discontinue supplement use followed by a 2-week washout prior to participation.
  * In all other cases, we will request that subjects maintain supplement use.

Exclusion Criteria:

* Subjects with any musculoskeletal injuries that would prevent exercising.
* Subjects with any metabolic disorder including known electrolyte abnormalities, diabetes, thyroid disease, adrenal disease or hypogonadism.
* Subjects with any inborn error of metabolism.
* Subjects with a history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
* Subjects with a personal history of heart disease, high blood pressure (systolic \>140 mm Hg \& diastolic \>90 mm Hg), psychiatric disorders, cancer, benign prostate hypertrophy, gastric ulcer, reflux disease, or any other medical condition deemed ineligible to participate in physical training by the ROTC athletic trainers or ROTC medical staff.
* Subjects currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or anti-coagulant medications.
* Subjects who are pregnant or lactating.

Primary outcomes:
measure: Change in Army Combat Fitness Test
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change in muscular power
timeFrame: Baseline and Week 6
measure: Change in muscular strength
timeFrame: Baseline and Week 6
measure: Change in aerobic capacity
timeFrame: Baseline and Week 6
measure: Change in body mass
timeFrame: Baseline and Week 6
measure: Change in body composition
timeFrame: Baseline and Week 6
measure: Change in muscle and tendon thickness
timeFrame: Baseline and Week 6
measure: Change in blood-based biomarkers
timeFrame: Baseline and Week 6
measure: Change in blood lactate responses
timeFrame: Baseline, Week 3, and Week 6
measure: Change in training distress
timeFrame: Baseline and every subsequent week through Week 6
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina Sport Science Lab
state: South Carolina
Study officials:
References: