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The purpose of this research is to evaluate if a hybrid semi-supervised remote exercise training program can reduce symptoms and improve quality of life and physical fitness in individuals with postural orthostatic tachycardia syndrome (POTS) and determine if this program is more effective than current standard of care.
To answer these questions, 60 individuals with POTS will be recruited to complete a symptom-limited cardiopulmonary exercise test with measures of cardiac output, autonomic function testing, blood volume measurement, and QOL questionnaires at baseline and following 3-months of treatment. Thirty participants will be randomized to continue with the standard of care which can include lower body and core strengthening, fluids, salt, medications and sometimes exercise. The other thirty participants will be asked to complete at least three exercise training sessions a week (progressing to 3hrs/wk of aerobic and 1hr/wk of strength training) and receive eight supervised training sessions over the 3-month treatment period. All participants will be provided with a polar heart rate monitor which will be linked to a connected health application to allow patients to track any aerobic workout, ensure during a session they are in the correct training zone, and allow the study team to remotely monitor adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Group | No Intervention | Subject with diagnosed with postural orthostatic tachycardia syndrome will continue to follow the treatment recommendations of the primary care physician | |
| Hybrid Exercise Training Group | Experimental | Subject with diagnosed with postural orthostatic tachycardia syndrome will follow a hybrid exercise training program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Exercise Training | Behavioral | Personalized exercise program completing at least 3 aerobic exercise sessions a week and receive eight supervised training sessions over the 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change Peak Oxygen consumption at 3 months | peak oxygen consumption measured from maximal cardiopulmonary exercise testing | baseline and following 3 month intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Composite Autonomic Symptom Score (COMPASS 31) at 3 months | Composite Autonomic Symptom Score a questionnaire of autonomic symptoms severity in 6 domains. Total score ranges from 0-100. Higher score means more severe autonomic symptoms. | baseline and following 3 month intervention |
| Change in Functional Ability Score at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anaerobic threshold oxygen consumption at 3 months | Change in oxygen consumption at anaerobic threshold measured from maximal cardiopulmonary exercise testing | baseline and following 3 month intervention |
| Change in matched workload oxygen consumption at 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney Wheatley-Guy, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Functional Ability Score asking patient to report their degree of limitation from 0-100% in 10% increments. 100% would be no limitation, feel normal, 10% is completely bedridden. |
| baseline and following 3 month intervention |
| Change in 36-Item Short Form Health Survey questionnaire (SF-36) at 3 months | 36-Item Short Form Health Survey questionnaire to evaluate quality of life and degree of health specifically focusing on the reported physical and mental components. Scores range from 0-100, where a higher score indicated better health. | baseline and following 3 month intervention |
| Change in heart rate with 10-min Stand test at 3 months | Change in heart rate in response to standing from supine to standing for 10 minutes | baseline and following 3 month intervention |
| Change in blood volume at 3 months | change in blood volume | baseline and following 3 month intervention |
Change in oxygen consumption at matched workload measured from maximal cardiopulmonary exercise testing |
| baseline and following 3 month intervention |
| Change in anaerobic threshold heart rate at 3 months | Change in heart rate at anaerobic threshold measured from maximal cardiopulmonary exercise testing | baseline and following 3 month intervention |
| Change in matched workload heart rate at 3 months | Change in heart rate at matched workload measured from maximal cardiopulmonary exercise testing | baseline and following 3 month intervention |
| Change in anaerobic threshold workload at 3 months | change in workload at anaerobic threshold measured from maximal cardiopulmonary exercise testing | baseline and following 3 month intervention |
| Change in anaerobic threshold rating of perceived exertion (RPE) at 3 months | change in RPE at anaerobic threshold measured from maximal cardiopulmonary exercise testing | baseline and following 3 month intervention |
| Change in matched workload rating of perceived exertion (RPE) at 3 months | Change in RPE at matched workload measured from maximal cardiopulmonary exercise testing | baseline and following 3 month intervention |
| Change in anaerobic threshold cardiac output at 3 months | change in cardiac output at anaerobic threshold measured from maximal cardiopulmonary exercise testing | baseline and following 3 month intervention |
| Change in matched workload cardiac output at 3 months | Change in cardiac output at matched workload measured from maximal cardiopulmonary exercise testing | baseline and following 3 month intervention |