Training Adaptations With and Without Ventilatory Training Device

University of South Carolina

Status: Completed

Conditions: Healthy

Treatments: Device: Respiratory Maximus Training Device; Device: No Respiratory Training Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06356181

Pro00135143

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Experimental

Experimental group

Description:

Participants in this group will undergo 6 weeks of high-intensity functional training using the respiratory muscle training device.

Treatment:

Device: Respiratory Maximus Training Device

Control

Active Comparator group

Description:

Participants in this group will undergo 6 weeks of high-intensity functional training without using the respiratory muscle training device.

Treatment:

Device: No Respiratory Training Device