Training Adaptations With and Without Ventilatory Training Device

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06356181
• Other study ID #: Pro00135143
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: University of South Carolina
• Contact: Shawn J Arent, PhD
• Phone: 8035768394
• Email: sarent[@]mailbox.sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Respiratory Maximus 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.
• No Respiratory Training Device
Those in the control group will train for 3 days per week of high-intensity functional training over 6-weeks.

Locations

Country	Name	City	State
United States	University of South Carolina Sport Science Lab	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	MAXIMUS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 %	Baseline and Week 8
Primary	Changes in aerobic capacity	Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.	Baseline and Week 8
Primary	Changes in peak power	Assessed via a cycle-ergometer based maximal graded exercise test	Baseline and Week 8
Primary	Changes in ventilatory threshold	Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.	Baseline and Week 8
Primary	Changes in countermovement jump	Assessed via force plates	Baseline and Week 8
Primary	Changes in anaerobic capacity	Assessed via 30-second Wingate test.	Baseline and Week 8
Primary	Changes in high-intensity functional training test	Assessed via a high-intensity functional training circuit composed of rows, pushups, and squats	Baseline and Week 8
Primary	Changes in heart rate at ventilatory threshold	Assessed via a cycle-ergometer based maximal graded exercise test with indirect calorimetry.	Baseline and Week 8
Secondary	Changes in body composition	Body fat percentage, fat-free mass, and fat mass via air-displacement plethysmography.	Baseline and Week 8
Secondary	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.	Baseline and Weeks 3, 5, and 7
Secondary	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.	Baseline and Weeks 3, 5, and 7
Secondary	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.	Baseline and Weeks 3, 5, and 7
Secondary	Change in blood lactate responses	Biochemical responses to exercise. Blood lactate sampled pre and post exercise during the last training day of the week.	Weeks 3, 5, and 7
Secondary	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.	Baseline and Weeks 3, 5, and 7.