Remote Self-training Program for Patients With Postural Orthostatic Tachycardia Syndrome (POTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change Peak Oxygen consumption at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Change Peak Oxygen consumption at 3 months
时间窗: baseline and following 3 month intervention
peak oxygen consumption measured from maximal cardiopulmonary exercise testing
次要结局
- Change in heart rate with 10-min Stand test 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 blood volume at 3 months(baseline and following 3 month intervention)
- Change in Composite Autonomic Symptom Score (COMPASS 31) at 3 months(baseline and following 3 month intervention)
研究者
Courtney M. Wheatley
Principal Investigator
Mayo Clinic