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Training Adaptations With and Without Ventilatory Training Device

High-Intensity Functional Training Adaptations With and Without Maximus Ventilatory Training Device

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06356181
Enrollment
32
Registered
2024-04-10
Start date
2024-03-18
Completion date
2024-10-29
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

high-intensity functional training, respiratory training device

Brief 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. 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.

Interventions

DEVICERespiratory Maximus Training Device

Those in the intervention group will wear the respiratory training device for 3 days per week of high-intensity functional training over 6-weeks.

DEVICENo Respiratory Training Device

Those in the control group will train for 3 days per week of high-intensity functional training over 6-weeks.

Sponsors

MAXIMUS
CollaboratorUNKNOWN
University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in heart rate at ventilatory thresholdBaseline and Week 8Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.
Changes in aerobic capacityBaseline and Week 8Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.
Changes in peak powerBaseline and Week 8Assessed via a cycle-ergometer based maximal graded exercise test
Changes in ventilatory thresholdBaseline and Week 8Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.
Changes in countermovement jumpBaseline and Week 8Assessed via force plates
Changes in anaerobic capacityBaseline and Week 8Assessed via 30-second Wingate test.
Changes in high-intensity functional training testBaseline and Week 8Assessed via a high-intensity functional training circuit composed of rows, pushups, and squats
Changes in spirometryBaseline and Week 8Spirometry measures of forced vital capacity (FVC) (L), forced expiratory volume at one second (FEV1) (L), and the ratio of FEV1/FVC %

Secondary

MeasureTime frameDescription
Changes in sleep qualityBaseline and Weeks 3, 5, and 7Assessed by Pittsburgh Sleep Quality Index. The minimum score is 0 and the maximum score is 40. Higher scores mean a worse outcome.
Changes in total mood disturbancesBaseline and Weeks 3, 5, and 7Assessed 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.
Changes in positive mood and emotionBaseline and Weeks 3, 5, and 7Assessed by the Positive and Negative Affect Schedule. Min values of 0 and max of 50, higher scores indicate more positive moods and emotions.
Change in blood lactate responsesWeeks 3, 5, and 7Biochemical responses to exercise. Blood lactate sampled pre and post exercise during the last training day of the week.
Changes in negative mood and emotionBaseline and Weeks 3, 5, and 7.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.
Changes in body compositionBaseline and Week 8Body fat percentage, fat-free mass, and fat mass via air-displacement plethysmography.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026