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

Primary Purpose

Postural Orthostatic Tachycardia Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hybrid Exercise Training

About this trial

This is an interventional health services research trial for Postural Orthostatic Tachycardia Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Mayo Clinic in Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care Group

Hybrid Exercise Training Group

Arm Description

Subject with diagnosed with postural orthostatic tachycardia syndrome will continue to follow the treatment recommendations of the primary care physician

Subject with diagnosed with postural orthostatic tachycardia syndrome will follow a hybrid exercise training program

Outcomes

Primary Outcome Measures

Change Peak Oxygen consumption at 3 months

peak oxygen consumption measured from maximal cardiopulmonary exercise testing

Secondary Outcome Measures

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.

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.

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.

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

Change in blood volume at 3 months

change in blood volume

Full Information

NCT ID

NCT04603157

First Posted

October 15, 2020

Last Updated

March 14, 2022

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04603157

Brief Title

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

February 18, 2022 (Actual)

Study Completion Date

February 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postural Orthostatic Tachycardia Syndrome

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care Group

Arm Type

No Intervention

Arm Description

Subject with diagnosed with postural orthostatic tachycardia syndrome will continue to follow the treatment recommendations of the primary care physician

Arm Title

Hybrid Exercise Training Group

Arm Type

Experimental

Arm Description

Subject with diagnosed with postural orthostatic tachycardia syndrome will follow a hybrid exercise training program

Intervention Type

Behavioral

Intervention Name(s)

Hybrid Exercise Training

Intervention Description

Personalized exercise program completing at least 3 aerobic exercise sessions a week and receive eight supervised training sessions over the 3-months

Primary Outcome Measure Information:

Title

Change Peak Oxygen consumption at 3 months

Description

peak oxygen consumption measured from maximal cardiopulmonary exercise testing

Time Frame

baseline and following 3 month intervention

Secondary Outcome Measure Information:

Title

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

Description

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

Title

Change in Functional Ability Score at 3 months

Description

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

Title

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

Description

Time Frame

baseline and following 3 month intervention

Title

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

Description

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

Time Frame

baseline and following 3 month intervention

Title

Change in blood volume at 3 months

Description

change in blood volume

Time Frame

baseline and following 3 month intervention

Other Pre-specified Outcome Measures:

Title

Change in anaerobic threshold oxygen consumption at 3 months

Description

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

Time Frame

baseline and following 3 month intervention

Title

Change in matched workload oxygen consumption at 3 months

Description

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

Time Frame

baseline and following 3 month intervention

Title

Change in anaerobic threshold heart rate at 3 months

Description

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

Time Frame

baseline and following 3 month intervention

Title

Change in matched workload heart rate at 3 months

Description

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

Time Frame

baseline and following 3 month intervention

Title

Change in anaerobic threshold workload at 3 months

Description

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

Time Frame

baseline and following 3 month intervention

Title

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

Description

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

Time Frame

baseline and following 3 month intervention

Title

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

Description

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

Time Frame

baseline and following 3 month intervention

Title

Change in anaerobic threshold cardiac output at 3 months

Description

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

Time Frame

baseline and following 3 month intervention

Title

Change in matched workload cardiac output at 3 months

Description

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

Time Frame

baseline and following 3 month intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Courtney Wheatley-Guy, PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Arizona

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

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