School of Public Health-Bloomington
Bloomington, Indiana, 47405, United States
NCT Number: NCT06336681
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.
Looking for future studies?
Notify Me18 year–35 year
All sexes
Interventional
Not applicable
Bloomington, Indiana, 47405, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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.
Time frame: 8 weeks
More specifically, differences in 16-km cycling time-trial completion time (seconds) before and after IMT.
Time frame: 8 weeks
More specifically, differences in 16-km cycling time-trial power output (watts) before and after IMT.
Time frame: 8 weeks
More specifically, differences in constant load performance (i.e., speed) before and after IMT.
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.
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.
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.
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
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
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
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
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
Indiana University
Other
Effect of Flow-Resistive Inspiratory Muscle Training on The Severity of Exercise-Induced Bronchoconstriction and Cycling Time-Trial Performance
Acronym: IMT_EIB
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.
Published trials that share one or more normalized conditions with this study.
NCT04234464
Asthma, Asthma, Exercise-Induced
Denver, Colorado, United States
View Trial DetailsNCT00273689
Asthma, Asthma, Exercise-Induced
Albuquerque, New Mexico, United States
View Trial DetailsNCT03505216
Asthma, Asthma, Exercise-Induced
Vienna, Austria
View Trial DetailsNCT00127166
Asthma, Asthma, Exercise-Induced
View Trial Details