Healthy Clinical Trial
Official title:
The Effects of a Minimal Equipment Training Approach Compared to Concurrent Training to Improve Warfighter Health and Performance
Verified date | November 2023 |
Source | University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 54 |
Est. completion date | June 29, 2022 |
Est. primary completion date | March 4, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of South Carolina Sport Science Lab | Columbia | South Carolina |
Lead Sponsor | Collaborator |
---|---|
University of South Carolina | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Army Combat Fitness Test | 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 | Change in muscular power | Assessed via countermovement vertical jump height. | Baseline and Week 6 | |
Secondary | Change in muscular strength | Assessed via 3-repetition maximum bench press. | Baseline and Week 6 | |
Secondary | Change in aerobic capacity | Assessed via treadmill-based maximal graded exercise test with indirect calorimetry. | Baseline and Week 6 | |
Secondary | Change in body mass | Body mass via calibrated scale. | Baseline and Week 6 | |
Secondary | Change in body composition | Body fat percentage, fat-free mass, and fat mass via air-displacement plethysmography. | Baseline and Week 6 | |
Secondary | Change in muscle and tendon thickness | Biceps brachii and quadriceps muscle thickness via B-mode ultrasound and distal biceps tendon and quadriceps tendon via B-mode ultrasound. | Baseline and Week 6 | |
Secondary | Change in blood-based biomarkers | Basal hormonal and biochemical assessments. Cortisol, interleukin (IL)-6, IL-10, IL-1ß, growth hormone (GH), and insulin-like growth factor-1 (IGF-1). | Baseline and Week 6 | |
Secondary | Change in blood lactate responses | Biochemical responses to exercise. Blood lactate sampled pre-, mid-, and post-exercise during training sessions in weeks 1, 3, and 6. | Baseline, Week 3, and Week 6 | |
Secondary | Change in training distress | 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. | Baseline and every subsequent week through Week 6 |
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