Remote Self-training Program for Patients With Postural Orthostatic Tachycardia Syndrome

Not Applicable

Completed

• Conditions: Postural Orthostatic Tachycardia Syndrome
• Interventions: Behavioral: Hybrid Exercise Training

• Registration Number: NCT04603157
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-23
• Study First Posted: 2020-10-26
• Primary Completion: 2022-02-18
• Study Completion: 2022-02-18
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Must be 18 years old or older
• Meet diagnosis criteria for POTS = a heart rate increase of ≥ 30bpm with supine to 10 minutes of standing or head-up tilt or heart rate exceeding 120 ppm after 10 minutes of standing or tilt without evidence of orthostatic hypertension (a fall in BP of > 20/10 mmHg)
• Been diagnosed with POTS ≥6 months prior to participation in the study (chronic)
• Female subjects must not be pregnant or trying to become pregnant during duration of study participation
• Those in exercise training group must be on stable medications for at least 1 month and medication must remain consistent for duration of study participation. For those in the standard of care group, a change in medication will be allowed within the first month following baseline testing, but then must remain consistent until 3-month testing time point.
• Ehlers-Danlos Syndrome (EDS) patients will be included, but will target equal randomization between treatment groups

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Exclusion Criteria

• Individual is not eligible if they are currently exercising, cut off >30 minutes of structured exercise/physical activity per week. (assessed by Global Physical Activity Questionnaire)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid Exercise Training Group	Hybrid Exercise Training	Subject with diagnosed with postural orthostatic tachycardia syndrome will follow a hybrid exercise training program

Primary Outcome Measures

Name	Time	Method
Change Peak Oxygen consumption at 3 months	baseline and following 3 month intervention	peak oxygen consumption measured from maximal cardiopulmonary exercise testing

Secondary Outcome Measures

Name	Time	Method
Change in heart rate with 10-min Stand test at 3 months	baseline and following 3 month intervention	Change in heart rate in response to standing from supine to standing for 10 minutes
Change in Functional Ability Score at 3 months	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.
Change in 36-Item Short Form Health Survey questionnaire (SF-36) at 3 months	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.
Change in blood volume at 3 months	baseline and following 3 month intervention	change in blood volume
Change in Composite Autonomic Symptom Score (COMPASS 31) at 3 months	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.

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States