An interventional study of Respiratory Maximus Training Device and No Respiratory Training Device in Healthy, sponsored by University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by University of South Carolina · Not applicable, Interventional, and Other
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.
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:
Researchers will compare 6 weeks of training with the ventilatory training device to those without the training device.
Participants will:
University of South Carolina is the lead sponsor of 191 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participant will be asked about dietary supplementation use within the past 6 months.
Exclusion Criteria:
Participants in this group will undergo 6 weeks of high-intensity functional training using the respiratory muscle training device.
Device: Respiratory Maximus Training Device
Participants in this group will undergo 6 weeks of high-intensity functional training without using the respiratory muscle training device.
Device: No Respiratory 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.
Those in the control group will train for 3 days per week of high-intensity functional training over 6-weeks.
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 %
Time frame: Baseline and Week 8
Changes in aerobic capacity
Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.
Time frame: Baseline and Week 8
Changes in peak power
Assessed via a cycle-ergometer based maximal graded exercise test
Time frame: Baseline and Week 8
Changes in ventilatory threshold
Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.
Time frame: Baseline and Week 8
Changes in countermovement jump
Assessed via force plates
Time frame: Baseline and Week 8
Changes in anaerobic capacity
Assessed via 30-second Wingate test.
Time frame: 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
Time frame: Baseline and Week 8
Changes in heart rate at ventilatory threshold
Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.
Time frame: Baseline and Week 8
Changes in body composition
Body fat percentage, fat-free mass, and fat mass via air-displacement plethysmography.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Weeks 3, 5, and 7.
Plan to share: No
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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University of South Carolina