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Postural Orthostatic Tachycardia Syndrome (POTS)NCT07182578

Programming Aquatic Therapy for POTS

A study testing Aquatic Occupational Therapy in people with Postural Orthostatic Tachycardia Syndrome (POTS), run by California State University, Dominguez Hills at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this pilot study is to create, implement, and evaluate an aquatic therapy for Postural Orthostatic Tachycardia Syndrome (POTS) program feasibility and ability to improve quality of life as determined by reduced orthostatic tachycardia, reduced POTS symptoms, and improved quality of life measures. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Aquatic Occupational Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
12 Sep 2025to 8 Feb 2026
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with POTS, Age 18-64, Participants must be English speaking, participants must obtain a physician permission letter* * The physician letter will only state that the participant is cleared to participate in aquatic therapy, it will not confirm or state what disease the individual has in the medical records or other HIPAA information.

Who cannot join

  • Not diagnosed with POTS, Not between the ages of 18-64*, Epilepsym Bowel incontinence
  • The reason for the age requirement is because individuals:
  • under 18 have different diagnostic criteria and mechanisms for POTS than the age range specified and may respond differently to treatment
  • over age 65 have different mechanisms behind POTS than younger individuals, and frequently have health conditions or factors that can be difficult to differentiate from POTS symptoms/diagnosis and would require lab work and continuous physician involvement. POTS is less common in older adults.
  • The typical age of onset for POTS is generally considered to be between the ages of 15-50 years of age
  • For participant's safety, the researcher needs to be able to communicate with them in the aquatic setting. English is the researcher's only language and electronic translators are not accessible/usable in the pool setting.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • California Aquatic Therapy & Wellness Center

    Long Beach, California, 90805

Other trials in United States

About this study

The goal of this pilot study is to create, implement, and evaluate an aquatic therapy for Postural Orthostatic Tachycardia Syndrome (POTS) program feasibility and ability to improve quality of life as determined by reduced orthostatic tachycardia, reduced POTS symptoms, and improved quality of life measures.

The main questions it aims to answer are:

Read more

Does aquatic occupational therapy reduce orthostatic tachycardia and POTS symptoms? Does aquatic occupational therapy lead to higher quality of live measures for people with POTS? Is this aquatic occupational therapy program feasible for clinicians and people with POTS?

There is no comparison group for this pilot study.

Participants will complete:

An occupational Therapy evaluation before and after program completion (3 hours total) 30 minutes at home/remote 30 minutes on-site/in-person 30 minutes of individualized occupational therapy on land

Participate in 3 aquatic therapy sessions per week, 60 minutes each for 12 weeks

Being tested
Aquatic Occupational Therapy
Keywords
Aquatic Therapy, Occupational therapy, POTS, Postural Orthostatic Tachycardia Syndrome, Dysautonomia, Rehabilitation, Hydrotherapy
Medical subject headings
Postural Orthostatic Tachycardia Syndrome, Autonomic Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aquatic Occupational TherapyOther

    Aquatic Occupational Therapy sessions will be 60 minutes long, with 45 minutes spent in the pool. Sessions will include a gentle floating, stretching, or aqua yoga warm-up and an ai chi cooldown. Exercises in the first month will include a focus on balance, breathing, and sensory work. Exercises in the second month will focus on building strength and endurance, while the third month will combine all of the above with dual-task completion. Activities will be graded down (made less difficult) or graded up (made more challenging) according to individual participant needs.

Study groups in NCT07182578
Study groupRoleWhat they receive
Aquatic Occupational Therapy InterventionExperimentalAll participants will participate in the aquatic occupational therapy arm. The aquatic occupational therapy intervention is divided into three progressive months: Month 1: Breathing techniques, proprioception, balance, and vestibular activities. Easy breathing and balancing moves Example: Belly breathing, water walking, toe lifts, mountain aqua yoga pose Month 2: Strength and endurance training Building strength and ability to exercise longer Example: Water marching, core exercises using dumbbells or paddles Month 3: Advanced strengthening and endurance tasks with integrated cognitive, balance, and dual-task challenges. Harder exercises and doing two things at once, like thinking and moving together Example: Dumbbell exercises while playing a word association game
Receives: Other: Aquatic Occupational Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. World Health Organization Quality of Life - Brief (WHOQOL-BREF)

    The WHOQOL-BREF is a 26-item questionnaire that will be completed digitally. It is scored by first assigning numerical values (1-5) to each response, with higher scores generally indicating a better quality of life. Then, raw domain scores are calculated by averaging the responses within each domain (Physical, Psychological, Social, and Environmental). Finally, these raw domain scores are transformed into scaled scores ranging from 0 to 100 by multiplying by 4. Higher scores on the 0-100 scale indicate a higher quality of life.

    The measure will be reported as a quality of life score.

    Measured: From enrollment to the end of 12 weeks of aquatic occupational therapy intervention

  2. The DePaul Symptom Questionnaire (Short Form) (DSQ-SF)

    14-item-questionnaire which measures post-exertional malaise symptoms over the last 6 months. Each question requires two ratings, one for frequency (0 = none of the time and 4 = all of the time) and one for severity (0 = symptom not present and 4 = very severe). A frequency of at least 2 and a severity of at least 2 on any one of the 5 questions on the DSQ-SF subscale indicate that post exertional malaise is present. For each symptom, the frequency and severity scores are averaged, and then multiplied by 25 to create a composite score out of 100.

    The measure will be reported as a post exertional malaise score.

    Measured: From enrollment to the end of 12 weeks of aquatic occupational therapy intervention.

  3. Composite Autonomic Symptom Score-31

    Measures neurodegenerative system symptoms through 31 patient-reported questions. Assessment is through six weighted domains: orthostatic intolerance [10 points]; vasomotor [6 points]; secretomotor [7 points]; gastrointestinal [28 points]; bladder [9 points] and pupillomotor [15 points]. A higher score indicates worse autonomic dysfunction. Simple yes or no questions are scored as 0 points for no and 1 point for yes. Questions about a specific site of symptoms or symptoms under specific circumstances are scored as 0 if not present and as 1 if present for each site or circumstance. All questions regarding the frequency of symptoms were scored as 0 points for rarely or never, 1 point for occasionally or sometimes, 2 points for frequently or "a lot of the time," and 3 points for almost always or constantly. All questions regarding the severity of symptoms were scored as 1 point for mild, 2 points for moderate, and 3 points for severe.

    The measure will be reported as a COMPASS score

    Measured: From enrollment to the end of 12 weeks of aquatic occupational therapy intervention.

  4. Malmo POTS Scale (MAPS)

    This 12-item questionnaire assesses the specific POTS symptom burden over the past 3 months. Each question uses a visual analog scale from 0-10, with a maximum score of 120. A score of 42 or higher is considered indicative of POTS.

    The measure will be reported as a MAPS score.

    Measured: From enrollment to the end of 12 weeks of aquatic occupational therapy intervention

  5. ADLS, IADLS, and Vestibular Questionnaire

    This is a 26-item questionnaire that will be filled out digitally. 21 questions cover about to participate in occupations listed in the Occupational Therapy Practice Framework using a scale from 1-10, where 1 is unable to complete the task, 5 is able to complete task with moderate difficulty (noticeable symptoms and extra effort is required) 10 is no problems/symptoms completing the task. It also contains 5 vestibular related questions using a scale from 1-7, with 1 being not at all dizzy, 4 being moderately dizzy, and 7 being extremely dizzy. The measure will be reported as an AIVQ score.

    Measured: From enrollment to the end of 12 weeks of aquatic occupational therapy intervention

  6. Active Stand Test

    The patient will begin laying down in a relaxed and comfortable position. Blood pressure (BP) and heart rate (HR) are taken after 5 minutes. Next, the patient will be asked to stand promptly, and will have their BP and HR measured immediately. The therapist will note any comments like "feeling dizzy". The BP and HR will be taken again and documented after three minutes, and again after ten minutes of standing. If there is any event, such as severe dizziness, paleness, etc, the BP and HR will be taken and documented just before the patient sits down.

    The measure will be reported as the position, time, and the correlated heart rate and blood pressure.

    Measured: From enrollment until the end of treatment at 12 weeks

  7. Single leg stance test

    This test measures a person's ability to balance standing on one leg without assistance. The participant will stand on one leg with their hands on their hips while being timed. The test is repeated 3 times for each leg and averaged. The measure will be reported as time standing per leg.

    Measured: From enrollment to the end of 12 weeks of aquatic occupational therapy intervention

  8. Heart Rate

    Heart rate (HR) will be measured on land while the participant is laying down, sitting up, and standing. HR in the water will be taken while seated and standing. An aquatic HR maximum and HR zones will be calculated for each participant. This measure will be reported as a land-based and aquatic HR maximum.

    Measured: From enrollment to the end of treatment at 12 weeks

  9. Borg's rate of perceived exertion scale

    This scale is used to tell how tiring an activity feels. The scale ranges from 6 (no exertion at all), to 20 (maximal heaviness). This will be reported as the RPE score.

    Measured: From enrollment to the end of treatment at 12 weeks

Secondary outcomes (11)
  1. The Stroop Test

    The Stroop Test is a measure of working memory and attention. A participant is asked to read words of various colors, say the color of the letters when they are the same, and when the colors don't match the words. They are timed and errors are tracked. This will be reported as the SCWT score.

    Measured: From enrollment to the end of 12 weeks of aquatic occupational therapy intervention

  2. Trail Making Test Parts A & B

    The participant is given a paper with numbers and letters, and is instructed to connect the letters and numbers in order (1-A-2-B-3-C, etc.), as quickly as possible, without lifting the pend or pencil from the paper. Errors will be pointed out immediately and the participant is allowed to correct it, but the time it takes to correct is still included in the completion time for the task. This will be reported as the TMT-A and TMT-B scores.

    Measured: From enrollment to the end of the intervention at 12 weeks

  3. Enrollment

    Total number of participants who complete the informed consent, evaluation session, and agree to participate in program according to schedule discussed with participant

    Measured: From enrollment to the end of treatment at 12 weeks

  4. Attrition Rate

    The number of enrolled participants who do not complete the program

    Measured: From enrollment to the end of treatment at 12 weeks

  5. Session attendance rate

    This will be calculated by the number of sessions attended out of the total number of sessions for the program.

    Measured: From enrollment to the end of treatment at 12 weeks

  6. Cost analysis

    This measure will include resource tracking and total costs divided by the number of completers.

    Measured: From enrollment to the end of treatment at 12 weeks

  7. Health utilization changes

    This will include a calculation of health utilization changes from before the program compared to after the program

    Measured: From enrollment to the end of treatment at 12 weeks

  8. Satisfaction Analysis

    Thematic analysis of open-ended feedback from participants and stakeholders will determine the most common themes and areas for improvement within the program.

    Measured: From enrollment to the end of treatment at 12 weeks

  9. Exercise self-efficacy

    Measure will be completed before the program and compared to the result after, leading to an ESE score.

    Measured: From enrollment to the end of treatment at 12 weeks

  10. Goal Attainment Scaling

    Goal attainment scaling is a method to turn individualized goals into a 5-point evaluation method, using a score of -2 to + 2 to quantify progress towards the specific goals. It measures the outcomes against expected results, where 0 is the expected outcome, -2 is much less than the expected outcome, and +2 is much more than the expected outcome.

    Measured: From enrollment to the end of treatment at 12 weeks

  11. Beighton Score

    The Beighton score is a screener for hypermobility and can be done quickly and simply with no testing materials needed. It consists of a 5-point scale, requires 5 maneuvers. It involves the evaluation of only a small number of joints, so any hypermobile joints not in this group may be overlooked.

    Measured: From enrollment to the end of treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2025
  2. Study start12 Sep 2025
  3. Primary completion8 Feb 2026
  4. Study completion8 Feb 2026

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07182578
Sponsor's protocol ID
IRB-FY2025-162
Status last verified
Mar 2026
First submitted
10 Sep 2025
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The final dataset will include individual-level vaccination and demographic data, as well as other health characteristics. We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. We will share the final dataset under our own auspices and by our own determination based on review of a detailed research plan submitted by the requestor.

Questions about this trial

What is this clinical trial studying?

A study testing Aquatic Occupational Therapy in people with Postural Orthostatic Tachycardia Syndrome (POTS), run by California State University, Dominguez Hills 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 1 inclusion and 6 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 3 Apr 2026. 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?

World Health Organization Quality of Life - Brief (WHOQOL-BREF) (time frame: From enrollment to the end of 12 weeks of aquatic occupational therapy intervention). The study lists 9 primary outcomes in all. 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 3 Apr 2026.

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