Physical Counterpressure Maneuvers in Postural Orthostatic Tachycardia Syndrome (POTS) - a Monocentric, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Malmö Postural Orthostatic Tachycardia Syndrome symptom score (MAPS)
研究概览
简要总结
The present study evaluates whether performing a 14-days counter pressure maneuvers (CPM)-biofeedback training improves the symptomatic burden (primary objective) and secondarily the interference of POTS symptoms with daily activities, fatigue, and health-related quality of life of individuals with POTS compared to best clinical practice non-pharmacological measures. Secondary in-laboratory objectives are to assess the influence of CPM on the supine-to-standing heart rate (HR) and blood pressure (BP) changes as well as on the severity of orthostatic intolerance after performing CPM for two minutes compared to a baseline (intervention-free) active standing test, and to assess the safety and tolerability of CPM-biofeedback training in individuals with POTS.
This is a monocentric, proof-of-concept, 1:1 randomized, controlled trial with rater-blinded evaluation of the hemodynamic effect of CPM in 40 individuals suffering from POTS.
All study participants will receive detailed counselling on CPM and other behavioral and non-pharmacological measures to combat POTS symptoms in daily life and will be invited to practice them regularly (best clinical practice). Participants randomized to the interventional arm will receive a CPM-biofeedback training session in the autonomic function laboratory at the Department of Neurology of the Innsbruck Medical University to learn four different CPM under continuous HR and BP monitoring. The CPM-biofeedback training will consist of a baseline 2-minutes active standing and the following four different physical maneuver: leg crossing and muscle tensing, heel raises (10 tiptoeing per minute), squatting, unilateral handgrip (20 times a minute).
The trial foresees three study visits for both the interventional and the control arm (screening and baseline on-site, as well as a telephone visit 14 days later). For the interventional trial arm, two additional visits are planned (CPM-biofeedback training session in the autonomic function laboratory and a follow-up telephone visit 7 days later).
To evaluate the baseline to day-14 change in symptom severity, the Malmö POTS Score (MAPS) total score (primary endpoint) and the MAPS single items, Vanderbilt Orthostatic Symptom Score, Orthostatic Grading Scale, Fatigue Severity Scale and Health-related Quality of Life Questionnaire (EuroQol -EQ-5D-5L ) will be administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •POTS diagnosis
- •18 to 80 years of age at time of consent
- •stable medication in the seven days prior to the baseline visit
- •able to provide written informed consent
排除标准
- •participation in other interventional trials
- •pregnant or breastfeeding females
- •on treatment with vasoactive medications including medications for heart rate control
- •acute infections at the time of enrolment or in the two weeks before
- •acute pain
- •surgery in the last three months
- •inability or contraindication for performing hip and knee flexion, hip adduction or squatting
- •inability to stand for at least two minutes
- •Any other cardiological, internal, psychiatric or neurological condition, which may prevent engagement in the sturdy procedures in the judgement of the investigator
结局指标
主要结局
Malmö Postural Orthostatic Tachycardia Syndrome symptom score (MAPS)
时间窗: Baseline to day-14
Baseline to day-14 change in the total score from 0 to 120. Higher scores means more symptoms and higher symptom severity.
次要结局
- Adverse events(Screening-Visit to day-14)
- Severity of orthostatic intolerance (on a 0 - 10 points scale)(After performing four different counterpressure maneuvers for two minutes each during the biofeedback session, at day 1 +/-3.)
- Absolute heart rate(At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuver practiced upon standing , at day 1 +/-3.)
- Absolute systolic and diastolic blood pressure(At 15, 30, 60, 90 and 120 seconds during counterpressure maneuver practiced upon standing, , at day 1 +/-3.)
- Supine-to-standing change in heart rate(At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3.)
- Supine-to-standing change in systolic and diastolic blood pressure(At 15, 30, 60, 90 and 120 seconds during four different counterpressure maneuvers, at day 1 +/-3.)
- Single items of the Malmö POTS Score (MAPS)(Baseline to day-14)
- Vanderbilt Orthostatic Symptom Score (VOSS)(Baseline to day-14)
- Orthostatic Grading Scale (OGS)(Baseline to day-14)
- Fatigue Severity Scale (FSS) - german Version(Baseline to day-14)
- European Quality of Life, 5 Dimensions, 5 Levels (EuroQol -EQ-5D-5L - german Version)(Baseline to day-14)
- Estimated number and preferred choice of counterpressure maneuvers in daily life(Baseline to day-14)
- Overall usefulness of counterpressure maneuvers(Baseline to day-14)
- Barriers to counterpressure maneuver application in daily life(Baseline to day-14)