Clinical trial NCT06356181: Training Adaptations With and Without Ventilatory Training Device
Official title: High-Intensity Functional Training Adaptations With and Without Maximus Ventilatory Training Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: high-intensity functional training
respiratory training device
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: MAXIMUS
First posted: 2024-04-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in spirometry
timeFrame: Baseline and Week 8
measure: Changes in aerobic capacity
timeFrame: Baseline and Week 8
measure: Changes in peak power
timeFrame: Baseline and Week 8
measure: Changes in ventilatory threshold
timeFrame: Baseline and Week 8
measure: Changes in countermovement jump
timeFrame: Baseline and Week 8
measure: Changes in anaerobic capacity
timeFrame: Baseline and Week 8
measure: Changes in high-intensity functional training test
timeFrame: Baseline and Week 8
measure: Changes in heart rate at ventilatory threshold
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Changes in body composition
timeFrame: Baseline and Week 8
measure: Changes in sleep quality
timeFrame: Baseline and Weeks 3, 5, and 7
measure: Changes in total mood disturbances
timeFrame: Baseline and Weeks 3, 5, and 7
measure: Changes in positive mood and emotion
timeFrame: Baseline and Weeks 3, 5, and 7
measure: Change in blood lactate responses
timeFrame: Weeks 3, 5, and 7
measure: Changes in negative mood and emotion
timeFrame: Baseline and Weeks 3, 5, and 7.
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina Sport Science Lab
state: South Carolina
Study officials:
References: