HealthyNCT06356181
Training Adaptations With and Without Ventilatory Training Device
A study testing Respiratory Maximus Training Device and No Respiratory Training Device in people with Healthy, run by University of South Carolina at 1 site in United States.
Trial summary
This project aims to assess the effectiveness of using a Respiratory Muscle Training (RMT) device during high-intensity functional training (HIFT) to improve fitness and ventilatory parameters. Primary outcome measures include aerobic, anaerobic, and HIFT measures. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Respiratory Maximus Training Device and No Respiratory Training Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2024to 29 Oct 2024
- 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) who participate in at least 150 minutes per week of physical activity.
- Have not participated in HIFT training in the last 6 months.
- Provided written and dated informed consent to participate in the study.
- In good health as determined by medical history and is cleared for exercise.
- Participant will be asked about dietary supplementation use within the past 6 months.
- If participant 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 participant maintain supplement use.
Who cannot join
- Any musculoskeletal injuries that would prevent exercising.
- Any metabolic disorder including known electrolyte abnormalities, diabetes, uncontrolled thyroid disease, adrenal disease or hypogonadism.
- Any inborn error of metabolism.
- History of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
- Participants with a personal history of heart disease, high blood pressure (systolic >140 mm Hg \& diastolic >90 mm Hg),
- Participants who are pregnant, planning to become 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, 29208
About this study
Official title: High-Intensity Functional Training Adaptations With and Without Maximus Ventilatory Training Device
This project aims to assess the effectiveness of using a Respiratory Muscle Training (RMT) device during high-intensity functional training (HIFT) to improve fitness and ventilatory parameters. Primary outcome measures include aerobic, anaerobic, and HIFT measures. Secondary measures include sleep, affect, and mood state questionnaires. Participants will be randomized into one of two groups: with the RMT device and without the RMT device.
Read the detailed description
This study assesses the impact of a ventilatory training device, similar to a sports mouth guard worn during exercise, on various performance outcomes. The main questions it aims to answer are:
- Does the device improve fitness parameters: high-intensity functional training, anaerobic capacity, anaerobic peak and mean power output, maximal oxygen uptake, ventilatory threshold, and blood lactate responses to training?
- Does the device improve spirometry measures?
Researchers will compare 6 weeks of training with the ventilatory training device to those without the training device.
Participants will:
- Take part in a total of 8 weeks of study-related activity.
- Complete six total one- to two-hour pre- and post-testing sessions, which include a maximal oxygen uptake test, high-intensity functional training, body composition, spirometry, anaerobic power and capacity testing.
- Complete six weeks of 45-minute high-intensity functional training, three days per week.
- Conditions
- Healthy
- Being tested
- Respiratory Maximus Training Device, No Respiratory Training Device
- Keywords
- high-intensity functional training, respiratory training device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Maximus Training DeviceDevice
Those in the intervention group will wear the respiratory training device for 3 days per week of high-intensity functional training over 6-weeks.
No Respiratory Training DeviceDevice
Those in the control group will train for 3 days per week of high-intensity functional training over 6-weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants in this group will undergo 6 weeks of high-intensity functional training using the respiratory muscle training device. Receives: Device: Respiratory Maximus Training Device |
| Control | Active comparator | Participants in this group will undergo 6 weeks of high-intensity functional training without using the respiratory muscle training device. Receives: Device: No Respiratory Training Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in spirometry
Spirometry measures of forced vital capacity (FVC) (L), forced expiratory volume at one second (FEV1) (L), and the ratio of FEV1/FVC %
Measured: Baseline and Week 8
Changes in aerobic capacity
Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.
Measured: Baseline and Week 8
Changes in peak power
Assessed via a cycle-ergometer based maximal graded exercise test
Measured: Baseline and Week 8
Changes in ventilatory threshold
Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.
Measured: Baseline and Week 8
Changes in countermovement jump
Assessed via force plates
Measured: Baseline and Week 8
Changes in anaerobic capacity
Assessed via 30-second Wingate test.
Measured: Baseline and Week 8
Changes in high-intensity functional training test
Assessed via a high-intensity functional training circuit composed of rows, pushups, and squats
Measured: Baseline and Week 8
Changes in heart rate at ventilatory threshold
Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.
Measured: Baseline and Week 8
Secondary outcomes (6)
Changes in body composition
Body fat percentage, fat-free mass, and fat mass via air-displacement plethysmography.
Measured: Baseline and Week 8
Changes in sleep quality
Assessed by Pittsburgh Sleep Quality Index. The minimum score is 0 and the maximum score is 40. Higher scores mean a worse outcome.
Measured: Baseline and Weeks 3, 5, and 7
Changes in total mood disturbances
Assessed by the Profile of Mood States (POMS). The total mood is calculated by adding the negative subscales (tension, depression, fatigue, confusion, and anger) and subtracting the positive subscales (vigor, esteem-related affect). Minimum score of -36 and max score of 200. Lower scores for total mood disturbance are considered better.
Measured: Baseline and Weeks 3, 5, and 7
Changes in positive mood and emotion
Assessed by the Positive and Negative Affect Schedule. Min values of 0 and max of 50, higher scores indicate more positive moods and emotions.
Measured: Baseline and Weeks 3, 5, and 7
Change in blood lactate responses
Biochemical responses to exercise. Blood lactate sampled pre and post exercise during the last training day of the week.
Measured: Weeks 3, 5, and 7
Changes in negative mood and emotion
Assessed by the Positive and Negative Affect Schedule. Min values of 0 and max of 50, higher scores indicate more negative moods and emotions with lower scores indicating less negative moods and emotions.
Measured: Baseline and Weeks 3, 5, and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start18 Mar 2024
- Primary completion28 Oct 2024
- Study completion29 Oct 2024
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- MAXIMUS
- Responsible party
- Principal investigator, Shawn M. Arent, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356181
- Sponsor's protocol ID
- Pro00135143
- Status last verified
- Nov 2024
- First submitted
- 27 Mar 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chandler AJ, Martin-Diala C, Mastrofini GF, Stray-Gundersen S, Artsinger R, Nakagawa N, Arent SM. The Effects of High-Intensity Functional Training With a Respiratory Muscle Training Device on Performance, Mood, and Ventilatory Function. J Strength Cond Res. 2026 Oct 5. doi: 10.1519/JSC.0000000000005692. Online ahead of print. No abstract available.
PubMed 42832180
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Functional Training Adaptations With and Without Maximus Ventilatory Training Device
- ClinicalTrials.gov ID
- NCT06356181
- Acronym / sponsor ID
- Pro00135143
- Conditions
- Healthy
- Keywords
- high-intensity functional training, respiratory training device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- MAXIMUS
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 10 Apr 2024 (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.
This project aims to assess the effectiveness of using a Respiratory Muscle Training (RMT) device during high-intensity functional training (HIFT) to improve fitness and ventilatory parameters. Primary outcome measures include aerobic, anaerobic, and HIFT measures. Secondary measures include sleep, affect, and mood state questionnaires. Participants will be randomized into one of two groups: with the RMT device and without the RMT device.
Detailed description
This study assesses the impact of a ventilatory training device, similar to a sports mouth guard worn during exercise, on various performance outcomes. The main questions it aims to answer are:
- Does the device improve fitness parameters: high-intensity functional training, anaerobic capacity, anaerobic peak and mean power output, maximal oxygen uptake, ventilatory threshold, and blood lactate responses to training?
- Does the device improve spirometry measures?
Researchers will compare 6 weeks of training with the ventilatory training device to those without the training device.
Participants will:
- Take part in a total of 8 weeks of study-related activity.
- Complete six total one- to two-hour pre- and post-testing sessions, which include a maximal oxygen uptake test, high-intensity functional training, body composition, spirometry, anaerobic power and capacity testing.
- Complete six weeks of 45-minute high-intensity functional training, three days per week.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Respiratory Maximus Training DeviceParticipants in this group will undergo 6 weeks of high-intensity functional training using the respiratory muscle training device. |
| Control | Active comparator | Device: No Respiratory Training DeviceParticipants in this group will undergo 6 weeks of high-intensity functional training without using the respiratory muscle training device. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males and females between the ages of 18 and 35 (inclusive) who participate in at least 150 minutes per week of physical activity.
- Have not participated in HIFT training in the last 6 months.
- Provided written and dated informed consent to participate in the study.
- In good health as determined by medical history and is cleared for exercise.
- Participant will be asked about dietary supplementation use within the past 6 months.
Key exclusion criteria (6 listed)
- Any musculoskeletal injuries that would prevent exercising.
- Any metabolic disorder including known electrolyte abnormalities, diabetes, uncontrolled thyroid disease, adrenal disease or hypogonadism.
- Any inborn error of metabolism.
- History of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
- Participants with a personal history of heart disease, high blood pressure (systolic >140 mm Hg \& diastolic >90 mm Hg),
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 |
|---|---|---|
| Respiratory Maximus Training DeviceThose in the intervention group will wear the respiratory training device for 3 days per week of high-intensity functional training over 6-weeks. | Device | Experimental |
| No Respiratory Training DeviceThose in the control group will train for 3 days per week of high-intensity functional training over 6-weeks. | Device | Control |
Primary outcome
Changes in spirometry
Time frame: Baseline and Week 8
Spirometry measures of forced vital capacity (FVC) (L), forced expiratory volume at one second (FEV1) (L), and the ratio of FEV1/FVC %
Changes in aerobic capacity
Time frame: Baseline and Week 8
Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.
Changes in peak power
Time frame: Baseline and Week 8
Assessed via a cycle-ergometer based maximal graded exercise test
Changes in ventilatory threshold
Time frame: Baseline and Week 8
Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.
Changes in countermovement jump
Time frame: Baseline and Week 8
Assessed via force plates
Changes in anaerobic capacity
Time frame: Baseline and Week 8
Assessed via 30-second Wingate test.
Changes in high-intensity functional training test
Time frame: Baseline and Week 8
Assessed via a high-intensity functional training circuit composed of rows, pushups, and squats
Changes in heart rate at ventilatory threshold
Time frame: Baseline and Week 8
Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.
6 secondary outcomes
Changes in body composition
Time frame: Baseline and Week 8
Changes in sleep quality
Time frame: Baseline and Weeks 3, 5, and 7
Changes in total mood disturbances
Time frame: Baseline and Weeks 3, 5, and 7
Changes in positive mood and emotion
Time frame: Baseline and Weeks 3, 5, and 7
Change in blood lactate responses
Time frame: Weeks 3, 5, and 7
Changes in negative mood and emotion
Time frame: Baseline and Weeks 3, 5, and 7.
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 2 Dec 2024.
- Derived from this study: PubMed 42832180Chandler AJ, Martin-Diala C, Mastrofini GF, Stray-Gundersen S, Artsinger R, Nakagawa N, Arent SM. The Effects of High-Intensity Functional Training With a Respiratory Muscle Training Device on Performance, Mood, and Ventilatory Function. J Strength Cond Res. 2026 Oct 5. doi: 10.1519/JSC.0000000000005692. Online ahead of print. No abstract available.
- 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 Respiratory Maximus Training Device and No Respiratory Training Device in people with Healthy, 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 7 inclusion and 6 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 2 Dec 2024. 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?
Changes in spirometry (time frame: Baseline and Week 8). The study lists 8 primary outcomes in all. 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 NCT06356181, 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 2 Dec 2024.