HealthyNCT05003778
Minimal Equipment Training Approach to Improve Warfighter Performance
A study testing Traditional equipment resistance training, Minimal equipment resistance training and Blood flow restriction training in people with Healthy and Military Operations, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Military Operations
- What is being tested?
- Traditional equipment resistance training, Minimal equipment resistance training and Blood flow restriction training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 29 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina Sport Science Lab
Columbia, South Carolina, 29201
About this study
Official title: 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).
Read the 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.
- Conditions
- Healthy, Military Operations
- Being tested
- Traditional equipment resistance training, Minimal equipment resistance training, Blood flow restriction training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional equipment resistance trainingOther
Participants will undergo 6 weeks of traditional equipment resistance training
Minimal equipment resistance trainingOther
Participants will undergo 6 weeks of minimal equipment resistance training
Blood flow restriction trainingOther
Participants will undergo 6 weeks of blood flow restriction training
| Study group | Role | What they receive |
|---|---|---|
| Traditional equipment resistance and endurance training | Active comparator | Participants in this group undergo 6 weeks of concurrent resistance and endurance training using traditional equipment (i.e., power racks, barbells, dumbbells, etc.) Receives: Other: Traditional equipment resistance training |
| Minimal equipment resistance and endurance training | Experimental | 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.) Receives: Other: Minimal equipment resistance training |
| Minimal equipment resistance and endurance training with blood flow restriction | Experimental | 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 Receives: Other: Minimal equipment resistance training; Other: Blood flow restriction training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 6
Secondary outcomes (9)
Change in muscular power
Assessed via countermovement vertical jump height.
Measured: Baseline and Week 6
Change in muscular strength
Assessed via 3-repetition maximum bench press.
Measured: Baseline and Week 6
Change in aerobic capacity
Assessed via treadmill-based maximal graded exercise test with indirect calorimetry.
Measured: Baseline and Week 6
Change in body mass
Body mass via calibrated scale.
Measured: Baseline and Week 6
Change in body composition
Body fat percentage, fat-free mass, and fat mass via air-displacement plethysmography.
Measured: Baseline and Week 6
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.
Measured: Baseline and Week 6
Change in blood-based biomarkers
Basal hormonal and biochemical assessments. Cortisol, interleukin (IL)-6, IL-10, IL-1β, growth hormone (GH), and insulin-like growth factor-1 (IGF-1).
Measured: Baseline and Week 6
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.
Measured: Baseline, Week 3, and Week 6
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.
Measured: Baseline and every subsequent week through Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start20 Nov 2020
- Primary completion4 Mar 2022
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Shawn M. Arent, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003778
- Sponsor's protocol ID
- Pro00103649
- Status last verified
- Nov 2023
- First submitted
- 21 Jul 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cintineo HP, Chandler AJ, Mastrofini GF, Lints BS, McFadden BA, Arent SM. Effects of Minimal-Equipment Resistance Training and Blood Flow Restriction on Military-Relevant Performance Outcomes. J Strength Cond Res. 2024 Jan 1;38(1):55-65. doi: 10.1519/JSC.0000000000004596.
PubMed 38085621
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Minimal Equipment Training Approach Compared to Concurrent Training to Improve Warfighter Health and Performance
- ClinicalTrials.gov ID
- NCT05003778
- Acronym / sponsor ID
- Pro00103649
- Conditions
- Healthy, Military Operations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional equipment resistance and endurance training | Active comparator | Other: Traditional equipment resistance trainingParticipants in this group undergo 6 weeks of concurrent resistance and endurance training using traditional equipment (i.e., power racks, barbells, dumbbells, etc.) |
| Minimal equipment resistance and endurance training | Experimental | Other: Minimal equipment resistance trainingParticipants 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.) |
| Minimal equipment resistance and endurance training with blood flow restriction | Experimental | Other: Minimal equipment resistance training, Other: Blood flow restriction trainingParticipants 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional equipment resistance trainingParticipants will undergo 6 weeks of traditional equipment resistance training | Other | Traditional equipment resistance and endurance training |
| Minimal equipment resistance trainingParticipants will undergo 6 weeks of minimal equipment resistance training | Other | Minimal equipment resistance and endurance training, Minimal equipment resistance and endurance training with blood flow restriction |
| Blood flow restriction trainingParticipants will undergo 6 weeks of blood flow restriction training | Other | Minimal equipment resistance and endurance training with blood flow restriction |
Primary outcome
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.
9 secondary outcomes
Change in muscular power
Time frame: Baseline and Week 6
Change in muscular strength
Time frame: Baseline and Week 6
Change in aerobic capacity
Time frame: Baseline and Week 6
Change in body mass
Time frame: Baseline and Week 6
Change in body composition
Time frame: Baseline and Week 6
Change in muscle and tendon thickness
Time frame: Baseline and Week 6
Change in blood-based biomarkers
Time frame: Baseline and Week 6
Change in blood lactate responses
Time frame: Baseline, Week 3, and Week 6
Change in training distress
Time frame: Baseline and every subsequent week through Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 38085621Cintineo HP, Chandler AJ, Mastrofini GF, Lints BS, McFadden BA, Arent SM. Effects of Minimal-Equipment Resistance Training and Blood Flow Restriction on Military-Relevant Performance Outcomes. J Strength Cond Res. 2024 Jan 1;38(1):55-65. doi: 10.1519/JSC.0000000000004596.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional equipment resistance training, Minimal equipment resistance training and Blood flow restriction training in people with Healthy and Military Operations, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Army Combat Fitness Test (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05003778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.