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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05003778
Other study ID # Pro00103649
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2020
Est. completion date June 29, 2022

Study information

Verified date November 2023
Source University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Traditional equipment resistance training
Participants will undergo 6 weeks of traditional equipment resistance training
Minimal equipment resistance training
Participants will undergo 6 weeks of minimal equipment resistance training
Blood flow restriction training
Participants will undergo 6 weeks of blood flow restriction training

Locations

Country Name City State
United States University of South Carolina Sport Science Lab Columbia South Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of South Carolina United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

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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