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Clinical Trials/NCT06356181
NCT06356181CompletedNot Applicable

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

University of South Carolina1 site in 1 country32 target enrollmentStarted: March 18, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
1
Primary Endpoint
Changes in spirometry

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts 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.

Arms & Interventions

Experimental

Experimental

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

Intervention: Respiratory Maximus Training Device (Device)

Control

Active Comparator

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

Intervention: No Respiratory Training Device (Device)

Outcomes

Primary Outcomes

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 %

Changes in aerobic capacity

Time Frame: Baseline and Week 8

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

Changes in countermovement jump

Time Frame: Baseline and Week 8

Assessed via force plates

Changes in peak power

Time Frame: Baseline and Week 8

Assessed via a cycle-ergometer based maximal graded exercise test

Changes in anaerobic capacity

Time Frame: Baseline and Week 8

Assessed via 30-second Wingate test.

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

Changes in ventilatory threshold

Time Frame: Baseline and Week 8

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

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

  • Changes in body composition(Baseline and Week 8)
  • Changes in positive mood and emotion(Baseline and Weeks 3, 5, and 7)
  • Changes in total mood disturbances(Baseline and Weeks 3, 5, and 7)
  • Changes in sleep quality(Baseline and Weeks 3, 5, and 7)
  • Change in blood lactate responses(Weeks 3, 5, and 7)
  • Changes in negative mood and emotion(Baseline and Weeks 3, 5, and 7.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shawn M. Arent

Professor and Chair of Exercise Science Department

University of South Carolina

Study Sites (1)

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