Clinical trial NCT04603157: Remote Self-training Program for Patients With Postural Orthostatic Tachycardia Syndrome
Official title: Remote Self-training Program for Patients With Postural Orthostatic Tachycardia Syndrome (POTS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Orthostatic Tachycardia Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

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)

Primary outcomes:
measure: Change Peak Oxygen consumption at 3 months
timeFrame: baseline and following 3 month intervention
Secondary outcomes:
measure: Change in Composite Autonomic Symptom Score (COMPASS 31) at 3 months
timeFrame: baseline and following 3 month intervention
measure: Change in Functional Ability Score at 3 months
timeFrame: baseline and following 3 month intervention
measure: Change in 36-Item Short Form Health Survey questionnaire (SF-36) at 3 months
timeFrame: baseline and following 3 month intervention
measure: Change in heart rate with 10-min Stand test at 3 months
timeFrame: baseline and following 3 month intervention
measure: Change in blood volume at 3 months
timeFrame: baseline and following 3 month intervention
Other outcomes:
measure: Change in anaerobic threshold oxygen consumption at 3 months
timeFrame: baseline and following 3 month intervention
measure: Change in matched workload oxygen consumption at 3 months
timeFrame: baseline and following 3 month intervention
measure: Change in anaerobic threshold heart rate at 3 months
timeFrame: baseline and following 3 month intervention
measure: Change in matched workload heart rate at 3 months
timeFrame: baseline and following 3 month intervention
measure: Change in anaerobic threshold workload at 3 months
timeFrame: baseline and following 3 month intervention
measure: Change in anaerobic threshold rating of perceived exertion (RPE) at 3 months
timeFrame: baseline and following 3 month intervention
measure: Change in matched workload rating of perceived exertion (RPE) at 3 months
timeFrame: baseline and following 3 month intervention
measure: Change in anaerobic threshold cardiac output at 3 months
timeFrame: baseline and following 3 month intervention
measure: Change in matched workload cardiac output at 3 months
timeFrame: baseline and following 3 month intervention
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Courtney Wheatley-Guy, PhD
role: PRINCIPAL_INVESTIGATOR
References: