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Behavioural Intervention

Inspiratory Muscle Training (IMT) group for Exercise-Induced Asthma (IMT_EIB Trial)

Phase 2

Recruiting

Led By Tim Mickleborough, Ph.D.

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

IMT_EIB Trial Summary

This trial aims to investigate whether training the muscles we use to breathe in can help people with exercise-induced breathing problems. The study will look at how this training affects the severity of breathing issues during exercise,

Who is the study for?

This trial is for competitive recreational or college athletes aged 18-35 with mild to moderate persistent asthma or EIB, a BMI of 18.5-28, and at least 1-2 years of cycling experience. They must have an FEV1 >65% predicted and not be on asthma maintenance meds, SSRIs, ADHD meds, painkillers regularly, fish oil supplements, nor have cardiovascular or other specified diseases.Check my eligibility

What is being tested?

The study tests if inspiratory muscle training (IMT) using the PrO2Fit Device can reduce the severity of exercise-induced bronchoconstriction (EIB), lessen short-acting beta-agonist use, improve lung function and oxygenation during exercise, decrease breathlessness and enhance time-trial cycling performance in athletes.See study design

What are the potential side effects?

While specific side effects are not listed for IMT with the PrO2Fit Device in this summary context; generally IMT may cause temporary muscular fatigue or soreness due to respiratory muscle exertion.

IMT_EIB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

16-km Cycling Time-Trial Power Output

16-km Cycling Time-Trial Time to Completion

Constant Load Performance

+2 more

Secondary outcome measures

Deoxygenation of the respiratory and limb locomotor muscles by near-infrared spectroscopy

Femoral blood flow (FBF) of the limb locomotor muscles by ultrasound

Lung Volumes

+1 more

IMT_EIB Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Inspiratory Muscle Training (IMT) groupExperimental Treatment1 Intervention

The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.

Group II: Sham Inspiratory Muscle Training (Sham-IMT) groupPlacebo Group1 Intervention

Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

981,742 Total Patients Enrolled

Tim Mickleborough, Ph.D.Principal InvestigatorIndiana University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase for this investigation currently ongoing?

"Based on the information available on clinicaltrials.gov, this medical investigation is currently seeking suitable participants. The trial was initially listed on 2/10/2022 and last revised on 3/27/2024."

Answered by AI

What are the safety implications of participating in a regimen focused on Inspiratory Muscle Training (IMT)?

"In this Phase 2 trial, the safety of the Inspiratory Muscle Training (IMT) group is rated as 2 by our team at Power. This implies that while some data supports safety, there is currently no evidence supporting efficacy."

Answered by AI

What is the primary aim of conducting this clinical investigation?

"The main focus of this clinical investigation, to be assessed over an 8-week period, is the performance in a 16-km Cycling Time-Trial Power Output. Additional measures include Perception of Breathing Intensity and Unpleasantness as well as Leg Fatigue evaluated on revised Borg Scales ranging from 0-10 during constant load cycling and the time-trial event. Ratings will range between 0-10 with higher values indicating heightened levels of intensity or fatigue. Furthermore, Deoxygenation status within respiratory and limb muscles using near-infrared spectroscopy throughout both exercise settings along with Lung Volumes during these activities are being monitored"

Answered by AI

Are participants of this research study required to be at least 20 years old?

"To be eligible for this research, individuals aged between 18 and 35 are sought after. There exist separate trials catered to participants below the age of 18 as well as those over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Tim Mickleborough 2022. "Inspiratory Muscle Training on The Severity of Exercise-Induced Bronchoconstriction and Time-Trial Performance (IMT_EIB)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06336681.

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