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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06336681
Other study ID # #12966
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 10, 2022
Est. completion date August 2025

Study information

Verified date March 2024
Source Indiana University
Contact Tim Mickleborough, Ph.D.
Phone (812) 855-0753
Email tmickleb@indiana.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Due to the lack of studies examining the impact of inspiratory muscle training (IMT) on the severity of exercise-induced bronchoconstriction (EIB) and exercise performance, the specific aim of this study is to assess the efficacy of flow-resistive IMT on EIB severity and symptoms, short-acting beta-2-agonist medication use, operating lung volumes, respiratory and limb locomotor muscle deoxygenation during constant-load cycling exercise, exertional dyspnea, and cycling time-trial performance.


Description:

To the investigators knowledge, no study has been conducted assessing the impact of inspiratory muscle training (IMT) on exercise-induced bronchoconstriction (EIB) severity, exertional dyspnea, and cycling time-trial performance. A review noted that studies examining the impact of IMT on asthma have all demonstrated an increase in inspiratory muscle strength (maximal inspiratory pressure, MIP) and endurance (sustained maximal inspiratory pressure). In addition, it has been observed that the reduction in the perception of dyspnea following and during exercise leads to a reduction in short-acting beta-2-agonist (SABA) use and fewer asthma symptoms. The same review also noted the lack of data available to explain the impacts of IMT on exercise performance and tolerance in athletes with EIB. Due to the lack of studies examining the impact of IMT on the severity of EIB and exercise performance, the specific aim of this study is to assess the efficacy of flow-resistive IMT on EIB severity and symptoms, SABA medication use, operating lung volumes, respiratory and limb locomotor muscle deoxygenation during constant-load cycling exercise, femoral blood flow, exertional dyspnea, and cycling time-trial performance. It is hypothesized that eight weeks of IMT will reduce EIB's severity and symptoms, respiratory and limb locomotor muscle deoxygenation, improve operating lung volumes, and exertional dyspnea and improve cycling time-trial performance.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Male and female, between the ages of 18 to 35 years. - Required to be a competitive recreational or college athlete and have at least 1-2 years of cycling or biking experience. - Body Mass Index (BMI) of 18.5 to 28 kg/m^2 - Considered "moderately to highly active" by the International Physical Activity Questionnaire (IPAQ). - Have clinically treated mild to moderate persistent asthma and/or exercise-induced bronchoconstriction (EIB), with a resting forced expiratory volume in 1 second (FEV1) > 65% of predicted. - A = 10% drop in FEV1 after eucapnic voluntary hyperpnea (EVH). - Prescribed short-acting ß2-agonists (SABAs) by a physician. - Comfortable not taking SABA before experimental visits. Exclusion Criteria: - History of smoking or recreational smoking, cardiovascular disease, renal disease, neurological disease, and metabolic disease. - Currently taking asthma maintenance medications (e.g., corticosteroids and leukotriene modifiers) - Any injuries in the past 6 months. - Taking selective serotonin reuptake inhibitors (SSRI)'s (antidepressants and anxiety medication), attention-deficit hyperactivity disorder (ADHD) medication, and chronically consume pain medication (Aleve, Tylenol, cannabidiol (CBD), etc.). - Has had or is positive for COVID-19. - Resting blood pressure of > 130 mmHg systolic or 90 mmHg diastolic. - Resting Pulse rate of > 100 bpm. - Regularly consuming fish oil supplements or eating more then one fish meal per week

Study Design


Intervention

Device:
PrO2Fit Device
The flow-resistive protocol using the device requires participants to maximally inhale as hard as they can and as long as they can against a small leak (2mm diameter hole) until task failure. This records maximum inspiratory pressure (MIP) and sustained maximal inspiratory pressure (SMIP) values which will be recorded and the best is chosen for the software template by the participant to continue their training session (previously described in arm/group description). The use of the device occurs three times a week, and used for 6-8 weeks.

Locations

Country Name City State
United States School of Public Health-Bloomington Bloomington Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exercise-Induced Bronchoconstriction (EIB) Severity More specifically, the pre- and post-values of the percentage drop in forced expiratory volume in 1 second (FEV1) from the eucapnic voluntary hyperpnea (EVH) test before and after IMT will be measured. Percentage drop in forced expiratory volume in 1 second (FEV1) will be reported in percentages. 8 weeks
Primary Maximum Inspiratory Pressure and Sustained Maximum Inspiratory Pressure More specifically, the pre- to post-values of maximum inspiratory pressure (reported as cmH2O) and sustained maximum inspiratory pressure (reported as pressure time units) before and after IMT will be measured. 8 weeks
Primary 16-km Cycling Time-Trial Time to Completion More specifically, differences in 16-km cycling time-trial completion time (seconds) before and after IMT. 8 weeks
Primary 16-km Cycling Time-Trial Power Output More specifically, differences in 16-km cycling time-trial power output (watts) before and after IMT. 8 weeks
Primary Constant Load Performance More specifically, differences in constant load performance (i.e., power output [watts]) before and after IMT. 8 weeks
Secondary Perception of Breathing Intensity and Unpleasantness and Leg Fatigue More specifically, whether IMT affects an individual's perception of exertional dyspnea (revised Borg Scales from 0-10 to rate breathing intensity and unpleasantness) and revised Borg Scales from 0-10 to rate leg fatigue during constant load cycling and a 16-km cycling time-trial. Scores will be reported as whole numbers between 0-10. Higher scores indicate extreme intensity, unpleasantness, or fatigue. 8 weeks
Secondary Deoxygenation of the respiratory and limb locomotor muscles by near-infrared spectroscopy More specifically, the effects of IMT on the deoxygenation of the respiratory and limb locomotor muscles during constant load cycling and a 16-km cycling time-trial 8 weeks
Secondary Femoral blood flow (FBF) of the limb locomotor muscles by ultrasound More specifically, the effects of IMT on femoral blood flow (FBF) of the limb locomotor muscles during constant load cycling 8 weeks
Secondary Lung Volumes More specifically, the effects of IMT on operating lung volumes during constant load cycling and a 16-km cycling time-trial. 8 weeks
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