Skip to main content
OpenTrials
Completed

NCT Number: NCT06356181

Training Adaptations With and Without 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina Sport Science Lab

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Respiratory Maximus Training Device

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.

No Respiratory Training Device

Device

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

Primary outcomes

  1. 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 %

  2. Changes in aerobic capacity

    Time frame: Baseline and Week 8

    Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.

  3. Changes in peak power

    Time frame: Baseline and Week 8

    Assessed via a cycle-ergometer based maximal graded exercise test

  4. Changes in ventilatory threshold

    Time frame: Baseline and Week 8

    Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.

  5. Changes in countermovement jump

    Time frame: Baseline and Week 8

    Assessed via force plates

  6. Changes in anaerobic capacity

    Time frame: Baseline and Week 8

    Assessed via 30-second Wingate test.

  7. 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

  8. 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.

Secondary outcomes

  1. Changes in body composition

    Time frame: Baseline and Week 8

    Body fat percentage, fat-free mass, and fat mass via air-displacement plethysmography.

  2. Changes in sleep quality

    Time frame: Baseline and Weeks 3, 5, and 7

    Assessed by Pittsburgh Sleep Quality Index. The minimum score is 0 and the maximum score is 40. Higher scores mean a worse outcome.

  3. Changes in total mood disturbances

    Time frame: Baseline and Weeks 3, 5, and 7

    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.

  4. Changes in positive mood and emotion

    Time frame: Baseline 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 positive moods and emotions.

  5. Change in blood lactate responses

    Time frame: Weeks 3, 5, and 7

    Biochemical responses to exercise. Blood lactate sampled pre and post exercise during the last training day of the week.

  6. Changes in negative mood and emotion

    Time frame: Baseline 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.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • MAXIMUS

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.