Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
NCT Number: NCT04603157
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Scottsdale, Arizona, 85259, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Personalized exercise program completing at least 3 aerobic exercise sessions a week and receive eight supervised training sessions over the 3-months
Time frame: baseline and following 3 month intervention
peak oxygen consumption measured from maximal cardiopulmonary exercise testing
Time frame: baseline and following 3 month intervention
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.
Time frame: baseline and following 3 month intervention
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.
Time frame: baseline and following 3 month intervention
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.
Time frame: baseline and following 3 month intervention
Change in heart rate in response to standing from supine to standing for 10 minutes
Time frame: baseline and following 3 month intervention
change in blood volume
Time frame: baseline and following 3 month intervention
Change in oxygen consumption at anaerobic threshold measured from maximal cardiopulmonary exercise testing
Time frame: baseline and following 3 month intervention
Change in oxygen consumption at matched workload measured from maximal cardiopulmonary exercise testing
Time frame: baseline and following 3 month intervention
Change in heart rate at anaerobic threshold measured from maximal cardiopulmonary exercise testing
Time frame: baseline and following 3 month intervention
Change in heart rate at matched workload measured from maximal cardiopulmonary exercise testing
Time frame: baseline and following 3 month intervention
change in workload at anaerobic threshold measured from maximal cardiopulmonary exercise testing
Time frame: baseline and following 3 month intervention
change in RPE at anaerobic threshold measured from maximal cardiopulmonary exercise testing
Time frame: baseline and following 3 month intervention
Change in RPE at matched workload measured from maximal cardiopulmonary exercise testing
Time frame: baseline and following 3 month intervention
change in cardiac output at anaerobic threshold measured from maximal cardiopulmonary exercise testing
Time frame: baseline and following 3 month intervention
Change in cardiac output at matched workload measured from maximal cardiopulmonary exercise testing
Mayo Clinic
Other
Remote Self-training Program for Patients With Postural Orthostatic Tachycardia Syndrome (POTS)
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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.
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