Postural Orthostatic Tachycardia SyndromeNCT04603157
Remote Self-training Program for Patients With Postural Orthostatic Tachycardia Syndrome
A study testing Hybrid Exercise Training in people with Postural Orthostatic Tachycardia Syndrome, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- Hybrid Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 18 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Hybrid Exercise Training
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Exercise TrainingBehavioural
Personalized exercise program completing at least 3 aerobic exercise sessions a week and receive eight supervised training sessions over the 3-months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Hybrid Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Peak Oxygen consumption at 3 months
peak oxygen consumption measured from maximal cardiopulmonary exercise testing
Measured: baseline and following 3 month intervention
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline and following 3 month intervention
Change in blood volume at 3 months
change in blood volume
Measured: baseline and following 3 month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Jan 2020
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Orthostatic Tachycardia SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney M. Wheatley, Mayo Clinic
- Investigators
- Courtney Wheatley-Guy, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603157
- Sponsor's protocol ID
- 20-007186
- Status last verified
- Mar 2022
- First submitted
- 15 Oct 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Self-training Program for Patients With Postural Orthostatic Tachycardia Syndrome (POTS)
- ClinicalTrials.gov ID
- NCT04603157
- Acronym / sponsor ID
- 20-007186
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Hybrid Exercise TrainingSubject with diagnosed with postural orthostatic tachycardia syndrome will follow a hybrid exercise training program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Exercise TrainingPersonalized exercise program completing at least 3 aerobic exercise sessions a week and receive eight supervised training sessions over the 3-months | Behavioural | Hybrid Exercise Training Group |
Primary outcome
Change Peak Oxygen consumption at 3 months
Time frame: baseline and following 3 month intervention
peak oxygen consumption measured from maximal cardiopulmonary exercise testing
5 secondary outcomes
Change in Composite Autonomic Symptom Score (COMPASS 31) at 3 months
Time frame: baseline and following 3 month intervention
Change in Functional Ability Score at 3 months
Time frame: baseline and following 3 month intervention
Change in 36-Item Short Form Health Survey questionnaire (SF-36) at 3 months
Time frame: baseline and following 3 month intervention
Change in heart rate with 10-min Stand test at 3 months
Time frame: baseline and following 3 month intervention
Change in blood volume at 3 months
Time frame: baseline and following 3 month intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney Wheatley-Guy, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Exercise Training in people with Postural Orthostatic Tachycardia Syndrome, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Peak Oxygen consumption at 3 months (time frame: baseline and following 3 month intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.