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Completed

NCT Number: NCT04603157

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Change Peak Oxygen consumption at 3 months

    Time frame: baseline and following 3 month intervention

    peak oxygen consumption measured from maximal cardiopulmonary exercise testing

Secondary outcomes

  1. Change in Composite Autonomic Symptom Score (COMPASS 31) at 3 months

    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.

  2. Change in Functional Ability Score at 3 months

    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.

  3. Change in 36-Item Short Form Health Survey questionnaire (SF-36) at 3 months

    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.

  4. Change in heart rate with 10-min Stand test at 3 months

    Time frame: baseline and following 3 month intervention

    Change in heart rate in response to standing from supine to standing for 10 minutes

  5. Change in blood volume at 3 months

    Time frame: baseline and following 3 month intervention

    change in blood volume

Other outcomes

  1. Change in anaerobic threshold oxygen consumption at 3 months

    Time frame: baseline and following 3 month intervention

    Change in oxygen consumption at anaerobic threshold measured from maximal cardiopulmonary exercise testing

  2. Change in matched workload oxygen consumption at 3 months

    Time frame: baseline and following 3 month intervention

    Change in oxygen consumption at matched workload measured from maximal cardiopulmonary exercise testing

  3. Change in anaerobic threshold heart rate at 3 months

    Time frame: baseline and following 3 month intervention

    Change in heart rate at anaerobic threshold measured from maximal cardiopulmonary exercise testing

  4. Change in matched workload heart rate at 3 months

    Time frame: baseline and following 3 month intervention

    Change in heart rate at matched workload measured from maximal cardiopulmonary exercise testing

  5. Change in anaerobic threshold workload at 3 months

    Time frame: baseline and following 3 month intervention

    change in workload at anaerobic threshold measured from maximal cardiopulmonary exercise testing

  6. Change in anaerobic threshold rating of perceived exertion (RPE) at 3 months

    Time frame: baseline and following 3 month intervention

    change in RPE at anaerobic threshold measured from maximal cardiopulmonary exercise testing

  7. Change in matched workload rating of perceived exertion (RPE) at 3 months

    Time frame: baseline and following 3 month intervention

    Change in RPE at matched workload measured from maximal cardiopulmonary exercise testing

  8. Change in anaerobic threshold cardiac output at 3 months

    Time frame: baseline and following 3 month intervention

    change in cardiac output at anaerobic threshold measured from maximal cardiopulmonary exercise testing

  9. Change in matched workload cardiac output at 3 months

    Time frame: baseline and following 3 month intervention

    Change in cardiac output at matched workload measured from maximal cardiopulmonary exercise testing

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2020
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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