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

NCT04603157 | Completed

• 1 other identifier: 20-007186
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Orthostatic Tachycardia Syndrome

Outcome Measures

Primary Outcomes (1)

• Change Peak Oxygen consumption at 3 months

  peak oxygen consumption measured from maximal cardiopulmonary exercise testing

  baseline and following 3 month intervention

Secondary Outcomes (5)

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

  baseline and following 3 month intervention

• Change in Functional Ability Score at 3 months

  baseline and following 3 month intervention

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

  baseline and following 3 month intervention

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

  baseline and following 3 month intervention

• Change in blood volume at 3 months

  baseline and following 3 month intervention

Other Outcomes (9)

• Change in anaerobic threshold oxygen consumption at 3 months

  baseline and following 3 month intervention

• Change in matched workload oxygen consumption at 3 months

  baseline and following 3 month intervention

• Change in anaerobic threshold heart rate at 3 months

  baseline and following 3 month intervention

Study Arms (2)

Standard of Care Group

NO INTERVENTION

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

Hybrid Exercise Training Group

EXPERIMENTAL

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

Behavioral: Hybrid Exercise Training

Interventions

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

Hybrid Exercise Training Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Study Officials

• Courtney Wheatley-Guy, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 26, 2020
• Study Start: January 1, 2020
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)