Inspiratory Muscle Training on The Severity of Exercise-Induced Bronchoconstriction and Time-Trial Performance (IMT_EIB)

Exercise Induced Asthma Clinical Trial

— IMT_EIB  

Official title:

Effect of Flow-Resistive Inspiratory Muscle Training on The Severity of Exercise-Induced Bronchoconstriction and Cycling Time-Trial Performance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336681
• Other study ID #: #12966
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Asthma, Exercise-Induced
• Bronchial Spasm
• Exercise Induced Asthma
• Exercise Induced Bronchospasm

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