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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspiratory Muscle Training (IMT) group | Experimental | 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. |
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| Sham Inspiratory Muscle Training (Sham-IMT) group | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Maximum Inspiratory Pressure | More specifically, the pre- to post-values of maximum inspiratory pressure (reported as cmH2O) before and after IMT will be measured. | 8 weeks |
| Sustained Maximum Inspiratory Pressure | More specifically, the pre- to post-values of sustained maximum inspiratory pressure (reported as pressure time units) before and after IMT will be measured. | 8 weeks |
| 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 |
| 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 |
| Constant Load 1 and 2 Speed | More specifically, differences in constant load performance (i.e., speed) before and after IMT. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 1 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Mickleborough, Ph.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Public Health-Bloomington | Bloomington | Indiana | 47405 | United States |
The plan to share individual participant data (IPD) is still unknown. However, if other researchers request IPD, we will evaluate that request and determine to share IPD.
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Participants were recruited via flyers posted in the School of Public Health and distributed in Kinesiology labs (e.g., SPH-K409, SPH-K535) and other departmental courses. Flyers were also shared on the IU Classifieds website to reach the broader IU community. 15 participants enrolled; 11 completed the study. 4 withdrew or were excluded (EIB criteria not met or training noncompliance). Recruitment occurred from April 2022 to April 2025 at the School of Public Health.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inspiratory Muscle Training (IMT) Group | 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. |
| FG001 | Sham Inspiratory Muscle Training (Sham-IMT) Group | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Inspiratory Muscle Training (IMT) Group | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 18 to 35 years old | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Posted | Mean | Standard Deviation | Percentage (%) | 8 weeks |
|
from enrollment through end of study, up to 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inspiratory Muscle Training (IMT) Group | 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. |
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Key limitations include a small, imbalanced sample (particularly Sham-IMT), increasing risk of Type II error and unstable interaction estimates. Baseline fitness differences may have biased performance outcomes. EIB variability, unsupervised training, and fixed resistance may have reduced treatment precision. Mechanistic measures were not assessed. Learning effects and methodological variability may have influenced kinetics data. Findings may not generalize beyond recreationally active people.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Timothy D Mickleborough | Indiana University | 812-855-0753 | tmickleb@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2026 | Feb 19, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2023 | Feb 19, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001250 | Asthma, Exercise-Induced |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| 8 weeks |
| Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 2 | 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. | 8 weeks |
| Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Time-Trial Cycling | 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. | 8 weeks |
| Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 1 | 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 | 8 weeks |
| Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 2 | More specifically, the effects of IMT on the deoxygenation of the respiratory and limb locomotor muscles during constant load 2 (CL2) cycling | 8 weeks |
| Deoxygenation of the Respiratory and Limb Locomotor Muscles During Time-Trial Cycling | More specifically, the effects of IMT on the deoxygenation of the respiratory and limb locomotor muscles during a 16-km cycling time-trial | 8 weeks |
| Femoral Blood Flow of the Limb Locomotor Muscles During Constant Load 1 | More specifically, the effects of IMT on femoral blood flow (FBF) of the limb locomotor muscles during constant load 1 (CL1) cycling | 8 weeks |
| Femoral Blood Flow of the Limb Locomotor Muscles During Constant Load 2 | More specifically, the effects of IMT on femoral blood flow (FBF) of the limb locomotor muscles during constant load 2 (CL2) cycling | 8 weeks |
| BG001 | Sham Inspiratory Muscle Training (Sham-IMT) Group | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
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| Sex: Female, Male | The aim for each arm was to have 10 participants in each group (IMT, Sham-IMT) for a total of 20. The ratio of males to females will be equal in each group (5 males to 5 females). However, we ended up with all males, 7 in the IMT group and 4 in the Sham-IMT group. Practical constraints of recruitment and scheduling, along with chance allocation, led to an underpowered and imbalanced Sham-IMT group. Females were included in recruitment; however, no females showed interest in participating in the study. | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| EIB Severity | Spirometry was performed according to American Thoracic Society guidelines. Baseline FEV₁ was obtained from the best of repeated maneuvers. Participants then completed a 6-min eucapnic voluntary hyperpnea (EVH) challenge at a target ventilation of 30 × FEV₁ while breathing dry gas. FEV₁ was reassessed at 5-min intervals for 30 min post-EVH. A ≥10% fall in FEV₁ confirmed EIB (mild 10-<25%, moderate 25-<50%, severe ≥50%). | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Mean | Standard Deviation | Percentage (%) |
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| MIP | Inspiratory muscle training (IMT) was performed using a flow-resistive device (PrO2Fit) with intensity prescribed relative to sustained maximal inspiratory pressure (SMIP), derived from the area under the pressure-time curve during a maximal inspiratory maneuver (TIRE protocol). Training intensity was set at ~80% of each session's best SMIP (sham: 30% SMIP). For interpretation of inspiratory strength, baseline maximal inspiratory pressure (MIP) was defined as the average of the first week of MIP values obtained during template-setting prior to training. | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Mean | Standard Deviation | centimeters of water (cmH2O) |
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| SMIP | Inspiratory muscle training (IMT) was performed using a flow-resistive device (PrO2Fit) with intensity prescribed relative to sustained maximal inspiratory pressure (SMIP), derived from the area under the pressure-time curve during a maximal inspiratory maneuver (TIRE protocol). Training intensity was set at ~80% of each session's best SMIP (sham: 30% SMIP). For interpretation of inspiratory strength, baseline maximal inspiratory pressure (SMIP) was defined as the average of the first week of MIP values obtained during template-setting prior to training. | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Mean | Standard Deviation | pressure time units (ptu) |
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| Constant Load 1 Speed | Participants will complete a constant load cycling at wattage set at 15% below their gas exchange threshold on a cycle ergometer that records speed during the constant watt cycling test. Speed was averaged over the entire completed constant load 1 (15% below). | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Mean | Standard Deviation | kilometers per hour (kph) |
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| Constant Load 2 Speed | Participants will complete a constant load cycling at wattage set at 15% above their gas exchange threshold on a cycle ergometer that records speed during the constant watt cycling test. Speed was averaged over the entire completed constant load 2 (15% above). Only 6 of the 7 participants in the IMT group completed the second constant load at baseline. | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Mean | Standard Deviation | kilometers per hour (kph) |
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| Time-Trial Time | Participants will complete a 16km time-trial cycling test on the cycle ergometer that records time to complete the distance during the cycling test. | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Mean | Standard Deviation | seconds (sec) |
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| Time-Trial Power | Participants will complete a 16km time-trial cycling test on the cycle ergometer that records power to complete the distance during the cycling test. Power was averaged over the entire 16km time-trial. | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Mean | Standard Deviation | Watts (W) |
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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. |
| OG001 | Sham Inspiratory Muscle Training (Sham-IMT) Group | 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. |
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| Primary | Maximum Inspiratory Pressure | More specifically, the pre- to post-values of maximum inspiratory pressure (reported as cmH2O) before and after IMT will be measured. | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Posted | Mean | Standard Deviation | cmH2O | 8 weeks |
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| Primary | Sustained Maximum Inspiratory Pressure | More specifically, the pre- to post-values of sustained maximum inspiratory pressure (reported as pressure time units) before and after IMT will be measured. | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Posted | Mean | Standard Deviation | ptu | 8 weeks |
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| 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. | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Posted | Mean | Standard Deviation | Seconds (sec) | 8 weeks |
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| Primary | 16-km Cycling Time-Trial Power Output | More specifically, differences in 16-km cycling time-trial power output (watts) before and after IMT. | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Posted | Mean | Standard Deviation | Watts (W) | 8 weeks |
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| Secondary | Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 1 | 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. | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 2 | 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. | After arm assignment, 1 participant ceased communication, they were not training and did not respond to scheduling attempts; excluded. 2 participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. 1 participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT=7 and Sham-IMT=4 fully completed. Baseline CL2 participant numbers were IMT=6 and Sham-IMT=4. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Time-Trial Cycling | 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. | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 1 | 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 | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Posted | Mean | Standard Deviation | micromolar (uM) | 8 weeks |
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| Secondary | Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 2 | More specifically, the effects of IMT on the deoxygenation of the respiratory and limb locomotor muscles during constant load 2 (CL2) cycling | After arm assignment, 1 participant ceased communication, they were not training and did not respond to scheduling attempts; excluded. 2 participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. 1 participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT=7 and Sham-IMT=4 fully completed. Baseline CL2 participant numbers were IMT=6 and Sham-IMT=4. | Posted | Mean | Standard Deviation | micromolar (uM) | 8 weeks |
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| Secondary | Deoxygenation of the Respiratory and Limb Locomotor Muscles During Time-Trial Cycling | More specifically, the effects of IMT on the deoxygenation of the respiratory and limb locomotor muscles during a 16-km cycling time-trial | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Posted | Mean | Standard Deviation | micromolar (uM) | 8 weeks |
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| Secondary | Femoral Blood Flow of the Limb Locomotor Muscles During Constant Load 1 | More specifically, the effects of IMT on femoral blood flow (FBF) of the limb locomotor muscles during constant load 1 (CL1) cycling | After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Posted | Mean | Standard Deviation | millimeters per minute (mL/min) | 8 weeks |
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| Secondary | Femoral Blood Flow of the Limb Locomotor Muscles During Constant Load 2 | More specifically, the effects of IMT on femoral blood flow (FBF) of the limb locomotor muscles during constant load 2 (CL2) cycling | After arm assignment, 1 participant ceased communication, they were not training and did not respond to scheduling attempts; excluded. 2 participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. 1 participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT=7 and Sham-IMT=4 fully completed. Baseline CL2 participant numbers were IMT=6 and Sham-IMT=4. | Posted | Mean | Standard Deviation | milliliters per minute (mL/min) | 8 weeks |
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| Primary | Constant Load 1 and 2 Speed | More specifically, differences in constant load performance (i.e., speed) before and after IMT. | After arm assignment, 1 participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; was excluded. 2 participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. 1 additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed. | Posted | Mean | Standard Deviation | kilometers per hour (kph) | 8 weeks |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Sham Inspiratory Muscle Training (Sham-IMT) Group | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
Not provided
Not provided
| D000092202 |
| Exercise-Induced Allergies |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Baseline - Dyspnea Unpleasantness |
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| Post-training - Dyspnea Unpleasantness |
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| Baseline - Leg Fatigue |
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| Post-training - Leg Fatigue |
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| The aim was to assess if IMT reduced dyspnea unpleasantness during CL1 (pre- to post-values) compared to Sham-IMT | ANOVA | Two way ANOVA looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects. | 0.781 | Two way ANOVA looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects. | Mean Difference (Final Values) | 0.223 | 2-Sided | 95 | -1.54 | 1.98 | Superiority |
| The aim was to assess if IMT reduced leg fatigue during CL1 (pre- to post-values) compared to Sham-IMT | ANOVA | Two way ANOVA looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects. | 0.772 | Two way ANOVA looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects. | Mean Difference (Final Values) | 0.321 | 2-Sided | 95 | -2.11 | 2.75 | Superiority |
| Post-training - Dyspnea Intensity |
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| Baseline - Dyspnea Unpleasantness |
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| Post-training - Dyspnea Unpleasantness |
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| Baseline - Leg Fatigue |
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| Post-training - Leg Fatigue |
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| The aim was to assess if IMT reduced dyspnea unpleasantness during CL2 (pre- to post-values) compared to Sham-IMT | Mixed Models Analysis | 0.364 | Due to missing data from baseline (PRE) compared to post-training data, a Mixed Effects Model was used, looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects. | Mean Difference (Final Values) | -1.02 | 2-Sided | 95 | -3.47 | 1.43 | Superiority |
| The aim was to assess if IMT reduced leg fatigue during CL2 (pre- to post-values) compared to Sham-IMT | Mixed Models Analysis | 0.365 | Due to missing data from baseline (PRE) compared to post-training data, a Mixed Effects Model was used, looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects. | Mean Difference (Final Values) | -0.985 | 2-Sided | 95 | -3.35 | 1.38 | Superiority |
| Baseline - Dyspnea Unpleasantness |
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| Post-training - Dyspnea Unpleasantness |
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| Baseline - Leg Fatigue |
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| Post-training - Leg Fatigue |
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| The aim was to assess if IMT reduced dyspnea unpleasantness during time-trial cycling (pre- to post-values) compared to Sham-IMT | ANOVA | Two way ANOVA looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects. | 0.585 | Two way ANOVA looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects. | Mean Difference (Final Values) | -0.330 | 2-Sided | 95 | -1.65 | 0.988 | Superiority |
| The aim was to assess if IMT reduced leg fatigue during time-trial cycling (pre- to post-values) compared to Sham-IMT | ANOVA | Two way ANOVA looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects. | 0.989 | Two way ANOVA looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects. | Median Difference (Final Values) | -0.00893 | 2-Sided | 95 | -1.38 | 1.36 | Superiority |
| Baseline - HHb RM |
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| Post-training - HHb RM |
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| The aim was to assess if IMT reduced respiratory deoxygenation during CL1 (pre- to post-values) compared to Sham-IMT | ANOVA | Two way ANOVA looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects | 0.138 | Two way ANOVA looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects | Mean Difference (Final Values) | 2.89 | 2-Sided | 95 | -1.13 | 6.91 | Superiority |
| Post-training - HHb LM |
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| Baseline - HHb RM |
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| Post-training - HHb RM |
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The aim was to assess if IMT reduced respiratory deoxygenation during CL2 (pre- to post-values) compared to Sham-IMT |
| Mixed Models Analysis |
| 0.683 |
Due to missing data from baseline (PRE) compared to post-training data, a Mixed Effects Model was used, looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects. |
| Mean Difference (Final Values) |
| 1.36 |
| 2-Sided |
| 95 |
| -6.05 |
| 8.76 |
| Superiority |
| Baseline - HHb RM |
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| Post-training - HHb RM |
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| The aim was to assess if IMT reduced respiratory deoxygenation time-trial cycling (pre- to post-values) compared to Sham-IMT | ANOVA | Two way ANOVA looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects. | 0.337 | Two way ANOVA looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects. | Mean Difference (Final Values) | -3.25 | 2-Sided | 95 | -10.5 | 4.00 | Superiority |
| Post-training - FBF |
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| The aim was to assess if IMT increased CL2 Speed (pre- to post-values) compared to Sham-IMT | Mixed Models Analysis | Due to missing data from baseline (PRE) comapred to post-training data, a Mixed Effects Model was used, looking at group (IMT vs Sham-IMT) by time (pr | 0.512 | Due to missing data from baseline (PRE) comapred to post-training data, a Mixed Effects Model was used, looking at group (IMT vs Sham-IMT) by time (pre-training vs post-training) interaction effects. | Mean Difference (Final Values) | 4.20 | 2-Sided | 95 | -9.03 | 17.4 | Superiority |