- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05003778
Minimal Equipment Training Approach to Improve Warfighter Performance
November 27, 2023 updated by: Shawn M. Arent, University of South Carolina
The Effects of a Minimal Equipment Training Approach Compared to Concurrent Training to Improve Warfighter Health and Performance
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).
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Carolina
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Columbia, South Carolina, United States, 29201
- University of South Carolina Sport Science Lab
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional equipment resistance and endurance training
Participants in this group undergo 6 weeks of concurrent resistance and endurance training using traditional equipment (i.e., power racks, barbells, dumbbells, etc.)
|
Participants will undergo 6 weeks of traditional equipment resistance training
|
|
Experimental: Minimal equipment resistance and endurance training
Participants in this group undergo 6 weeks of concurrent resistance and endurance training using minimal equipment (i.e., sandbags, resistance bands, suspension trainers, weight vests, etc.)
|
Participants will undergo 6 weeks of minimal equipment resistance training
|
|
Experimental: Minimal equipment resistance and endurance training with blood flow restriction
Participants in this group undergo 6 weeks of concurrent resistance and endurance training using minimal equipment (i.e., sandbags, resistance bands, suspension trainers, weight vests, etc.) while wearing upper- and lower-body blood-flow restriction cuffs
|
Participants will undergo 6 weeks of minimal equipment resistance training
Participants will undergo 6 weeks of blood flow restriction training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Army Combat Fitness Test
Time Frame: Baseline and Week 6
|
6-event task to assess various aspects of human performance (muscular power, muscular strength, muscular endurance, anaerobic capacity, and aerobic capacity).
Tests include 3-repetition maximum trap-bar deadlift, standing power throw with 10-lb ball, 2-min hand-release push-ups, sprint-drag-carry, 2-min leg tucks, and 2-mile run.
|
Baseline and Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in muscular power
Time Frame: Baseline and Week 6
|
Assessed via countermovement vertical jump height.
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Baseline and Week 6
|
|
Change in muscular strength
Time Frame: Baseline and Week 6
|
Assessed via 3-repetition maximum bench press.
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Baseline and Week 6
|
|
Change in aerobic capacity
Time Frame: Baseline and Week 6
|
Assessed via treadmill-based maximal graded exercise test with indirect calorimetry.
|
Baseline and Week 6
|
|
Change in body mass
Time Frame: Baseline and Week 6
|
Body mass via calibrated scale.
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Baseline and Week 6
|
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Change in body composition
Time Frame: Baseline and Week 6
|
Body fat percentage, fat-free mass, and fat mass via air-displacement plethysmography.
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Baseline and Week 6
|
|
Change in muscle and tendon thickness
Time Frame: Baseline and Week 6
|
Biceps brachii and quadriceps muscle thickness via B-mode ultrasound and distal biceps tendon and quadriceps tendon via B-mode ultrasound.
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Baseline and Week 6
|
|
Change in blood-based biomarkers
Time Frame: Baseline and Week 6
|
Basal hormonal and biochemical assessments.
Cortisol, interleukin (IL)-6, IL-10, IL-1β, growth hormone (GH), and insulin-like growth factor-1 (IGF-1).
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Baseline and Week 6
|
|
Change in blood lactate responses
Time Frame: Baseline, Week 3, and Week 6
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Biochemical responses to exercise.
Blood lactate sampled pre-, mid-, and post-exercise during training sessions in weeks 1, 3, and 6.
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Baseline, Week 3, and Week 6
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Change in training distress
Time Frame: Baseline and every subsequent week through Week 6
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Overall training distress and subscales including depressed moods, vigor, physical signs and symptoms, sleep disturbances, perceived stress, and general fatigue.
The Multicomponent Training Distress Scale will be administered weekly.
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Baseline and every subsequent week through Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2020
Primary Completion (Actual)
March 4, 2022
Study Completion (Actual)
June 29, 2022
Study Registration Dates
First Submitted
July 21, 2021
First Submitted That Met QC Criteria
August 11, 2021
First Posted (Actual)
August 12, 2021
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Pro00103649
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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