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This is a prospective interventional study of patients with Friedreich's Ataxia that receive respiratory strength training for a period of 12 weeks with two research visits at the beginning and at the end of the study period. Visits include swallowing evaluation with fiberoptic endoscopic evaluation of swallowing, pulmonary function testing, surface electromyography and patient surveys.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respiratory Strength Training (RST) | Experimental | Participants will receive a respiratory strength training device to take home and use up to 5 times a week for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory Strength Training (RST) | Other | Respiratory Strength training involves inhaling/exhaling against a fix resistant to potentially increase respiratory strength |
|
| Measure | Description | Time Frame |
|---|---|---|
| Force Vital Capacity | Forced Vital Capicity will be measured before and after the 12 week intervention | Through study completion (4 months) |
| Maximal Inspiratory Pressure (MIP) | Maximal Inspiratory Pressure (MIP) will be measured before and after the 12 week intervention | Through study completion (4 months) |
| Maximal Expiratory Pressure (MEP) | Maximal Expiratory Pressure (MEP) will be measured before and after the 12 week intervention | Through study completion (4 months) |
| Sniff Nasal Inspiratory Pressure (SNIP) | Sniff Nasal Inspiratory Pressure (SNIP) will be measured before and after the 12 week intervention | Through study completion (4 months) |
| Swallowing | Fiberoptic Endoscopic Evaluation of Swallowing (FEES) will be measured before and after the 12 week intervention. | Through study completion (4 months) |
| Surface Electromyography (sEMG) | sEMG will be placed on the skin to measure muscle activity involved in breathing and swallowing | Through study completion (4 months) |
| Diaphragm Ultrasound | Diaphragm movement will be measured through an ultrasound probe positioned on the skin before and after the 12 week intervention. | Through study completion (4 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Leon Astudillo, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D005621 | Friedreich Ataxia |
| ID | Term |
|---|---|
| D013132 | Spinocerebellar Degenerations |
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028361 | Mitochondrial Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |