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Completed

NCT Number: NCT06336681

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Public Health-Bloomington

Bloomington, Indiana, 47405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 β2-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

Treatment and study plan

PrO2Fit Device

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.

Other names: Flow-resistive inspiratory muscle training, Sham-Flow-resistive inspiratory muscle training

Primary outcomes

  1. Exercise-Induced Bronchoconstriction (EIB) Severity

    Time frame: 8 weeks

    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.

  2. Maximum Inspiratory Pressure

    Time frame: 8 weeks

    More specifically, the pre- to post-values of maximum inspiratory pressure (reported as cmH2O) before and after IMT will be measured.

  3. Sustained Maximum Inspiratory Pressure

    Time frame: 8 weeks

    More specifically, the pre- to post-values of sustained maximum inspiratory pressure (reported as pressure time units) before and after IMT will be measured.

  4. 16-km Cycling Time-Trial Time to Completion

    Time frame: 8 weeks

    More specifically, differences in 16-km cycling time-trial completion time (seconds) before and after IMT.

  5. 16-km Cycling Time-Trial Power Output

    Time frame: 8 weeks

    More specifically, differences in 16-km cycling time-trial power output (watts) before and after IMT.

  6. Constant Load 1 and 2 Speed

    Time frame: 8 weeks

    More specifically, differences in constant load performance (i.e., speed) before and after IMT.

Secondary outcomes

  1. Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 1

    Time frame: 8 weeks

    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 1 (CL1) cycling. Scores will be reported as whole numbers between 0-10. Higher scores indicate extreme intensity, unpleasantness, or fatigue.

  2. Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 2

    Time frame: 8 weeks

    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 2 (CL2) cycling. Scores will be reported as whole numbers between 0-10. Higher scores indicate extreme intensity, unpleasantness, or fatigue.

  3. Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Time-Trial Cycling

    Time frame: 8 weeks

    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 a 16-km cycling time-trial. Scores will be reported as whole numbers between 0-10. Higher scores indicate extreme intensity, unpleasantness, or fatigue.

  4. Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 1

    Time frame: 8 weeks

    More specifically, the effects of IMT on the deoxygenation (HHb) of the respiratory (RM) and limb locomotor muscles (LM) during constant load 1 (CL1) cycling

  5. Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 2

    Time frame: 8 weeks

    More specifically, the effects of IMT on the deoxygenation of the respiratory and limb locomotor muscles during constant load 2 (CL2) cycling

  6. Deoxygenation of the Respiratory and Limb Locomotor Muscles During Time-Trial Cycling

    Time frame: 8 weeks

    More specifically, the effects of IMT on the deoxygenation of the respiratory and limb locomotor muscles during a 16-km cycling time-trial

  7. Femoral Blood Flow of the Limb Locomotor Muscles During Constant Load 1

    Time frame: 8 weeks

    More specifically, the effects of IMT on femoral blood flow (FBF) of the limb locomotor muscles during constant load 1 (CL1) cycling

  8. Femoral Blood Flow of the Limb Locomotor Muscles During Constant Load 2

    Time frame: 8 weeks

    More specifically, the effects of IMT on femoral blood flow (FBF) of the limb locomotor muscles during constant load 2 (CL2) cycling

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Acronym: IMT_EIB

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 29, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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