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This study is being conducted by the Department of Kinesiology within the School of Public Health at Indiana University Bloomington. The purpose of this study is to better understand how inspiratory muscle strength training affects cardiovascular health and mood disturbance in postmenopausal women.
Inspiratory muscle training (IMT) works by strengthening the respiratory muscles through resistive airflow breathing using a handheld device. The goal being to elicit an adaptive response akin to resistance exercise for locomotor muscles. Labored breathing due to respiratory muscle weakness can detract from physical performance with attendant consequences on independent living. This may trigger a maladaptive cycle that worsens physiological and psychosocial outcomes. IMT from 6-10 weeks has been shown to increase maximal inspiratory pressure, functional capacity, and perceived breathlessness across disease states. To inform an appropriately powered randomized controlled trial, the present work proposes a 2-arm single-blind, randomized pilot study to evaluate outcomes of interest.
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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 4 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 4 times a week, and over 8-weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrO2 Fit (IMT Trainer) | Device | The device is used four times a week over a period of 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration | Duration, reported in seconds, to reach 63% of steady-state V̇O2 during a fixed-workload treadmill task. This technique is performed using breath-by-breath open-circuit spirometry and captures the V̇O2 fast component occurring in the transition from standing rest to treadmill walking. | Baseline, within 48 hours of completing intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Distance Traveled | Distance traveled, reported in meters, during a 6-minute walk test. The assessment offers reliable and valid insight concerning exercise capacity in older women. | Baseline, within 9 days of completing intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Vascular Reactivity | Cerebral vascular function will be measured in vivo evidenced by changes in cerebral blood flow velocity [i.e., reactivity (cm/s/mm Hg)] of the middle cerebral artery in response to randomized hypercapnic gas exposure. | Baseline, within 9 days of completing intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J Carter, Ph.D | Indiana University, Bloomington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Bloomington | Indiana | 47405 | United States |
No IDP sharing plan
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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All members of the research staff (i.e., those collecting data during experimental visits) will be blinded to the treatment group. The PI, who will not be part of data collection, will not be blinded.
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |