Recruiting

Aquatic Therapy for Postural Orthostatic Tachycardia Syndrome

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What is being tested

Aquatic Occupational Therapy

Other
Who is being recruted

Autonomic Nervous System Diseases
+2

+ Nervous System Diseases
+ Primary Dysautonomias
From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorCalifornia State University, Dominguez Hills
Study ContactEvaRose Celeste, OT Doctoral studentMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 12, 2025Actual date on which the first participant was enrolled.

This study is focusing on developing and testing a water-based therapy program for individuals with Postural Orthostatic Tachycardia Syndrome (POTS). POTS is a condition that affects circulation and can lead to symptoms like dizziness, fainting, and rapid heartbeat when standing up. The study aims to see if participating in aquatic therapy can reduce these symptoms, improve overall quality of life, and be a practical option for both patients and healthcare providers. By addressing these aspects, the study hopes to find new, effective ways to help those living with POTS manage their symptoms better. Participants in this study will take part in a structured program that includes three water therapy sessions each week, each lasting an hour, over a period of twelve weeks. Before and after the program, participants will undergo a detailed evaluation conducted by an occupational therapist, which includes assessments both at home and in-person. The study does not have a comparison group, focusing solely on the effects of the therapy itself. Through this setup, the study will measure changes in heart rate and symptom severity, as well as gather feedback on how feasible and beneficial the therapy is for improving daily life for those with POTS.

Official TitleProgramming Aquatic Therapy for POTS 
NCT07182578
Principal SponsorCalifornia State University, Dominguez Hills
Study ContactEvaRose Celeste, OT Doctoral studentMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
12 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Autonomic Nervous System Diseases
Nervous System Diseases
Primary Dysautonomias
Orthostatic Intolerance
Postural Orthostatic Tachycardia Syndrome
Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
All 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

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 Objectives
Primary Objectives

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.

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.

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

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.

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.

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.

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.

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.

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.
Secondary Objectives

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.

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.

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

The number of enrolled participants who do not complete the program

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

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

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

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

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
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California Aquatic Therapy & Wellness CenterLong Beach, United StatesSee the location
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One Study Center
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