Programming Aquatic Therapy for POTS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- World Health Organization Quality of Life - Brief (WHOQOL-BREF)
研究概览
简要总结
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:
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
World Health Organization Quality of Life - Brief (WHOQOL-BREF)
时间窗: From enrollment to the end of 12 weeks of aquatic occupational therapy intervention
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.
The DePaul Symptom Questionnaire (Short Form) (DSQ-SF)
时间窗: From enrollment to the end of 12 weeks of aquatic occupational therapy intervention.
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.
Composite Autonomic Symptom Score-31
时间窗: From enrollment to the end of 12 weeks of aquatic occupational therapy intervention.
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
Malmo POTS Scale (MAPS)
时间窗: From enrollment to the end of 12 weeks of aquatic occupational therapy intervention
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.
ADLS, IADLS, and Vestibular Questionnaire
时间窗: From enrollment to the end of 12 weeks of aquatic occupational therapy intervention
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.
Active Stand Test
时间窗: From enrollment until the end of treatment at 12 weeks
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.
Single leg stance test
时间窗: From enrollment to the end of 12 weeks of aquatic occupational therapy intervention
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
时间窗: From enrollment to the end of treatment at 12 weeks
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.
Borg's rate of perceived exertion scale
时间窗: From enrollment to the end of treatment at 12 weeks
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.
次要结局
- Session attendance rate(From enrollment to the end of treatment at 12 weeks)
- Trail Making Test Parts A & B(From enrollment to the end of the intervention at 12 weeks)
- Attrition Rate(From enrollment to the end of treatment at 12 weeks)
- The Stroop Test(From enrollment to the end of 12 weeks of aquatic occupational therapy intervention)
- Enrollment(From enrollment to the end of treatment at 12 weeks)
- Cost analysis(From enrollment to the end of treatment at 12 weeks)
- Health utilization changes(From enrollment to the end of treatment at 12 weeks)
- Satisfaction Analysis(From enrollment to the end of treatment at 12 weeks)
- Exercise self-efficacy(From enrollment to the end of treatment at 12 weeks)
研究者
EvaRose Celeste
Principal Investivator
California State University, Dominguez Hills