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

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

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.

Study Overview

• Status: Completed
• Conditions: Postural Orthostatic Tachycardia Syndrome
• Intervention / Treatment: Behavioral: Hybrid Exercise Training

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care Group; Subject with diagnosed with postural orthostatic tachycardia syndrome will continue to follow the treatment recommendations of the primary care physician
Experimental: Hybrid Exercise Training Group; Subject with diagnosed with postural orthostatic tachycardia syndrome will follow a hybrid exercise training program	Behavioral: Hybrid Exercise Training; Personalized exercise program completing at least 3 aerobic exercise sessions a week and receive eight supervised training sessions over the 3-months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Courtney Wheatley-Guy, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): February 18, 2022
• Study Completion (Actual): February 18, 2022

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Disease; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Syndrome; Tachycardia; Postural Orthostatic Tachycardia Syndrome
• Other Study ID Numbers: 20-007186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No