Effect of Resonance Frequency Paced Breathing as an Adjuvant to Standard Treatment on Heart Rate and Cardiac Autonomic Parameters in Patients with Postural Orthostatic Tachycardia Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in heart rate response during the tilt table test (with and without resonance paced breathing).
研究概览
简要总结
Background: POTS is an autonomic disorder that significantly impacts the quality of life, with limited treatment options available. While symptomatic management remains the primary approach, there is a growing need for alternative, non-pharmacological interventions. RF-paced breathing, a controlled breathing technique that synchronizes heart rate and respiration, has shown potential in improving autonomic function and heart rate variability (HRV), offering a novel therapeutic strategy.
Novelty: Unlike existing studies that primarily assess the short-term effects of slow breathing, this study introduces a novel approach by utilizing extended RF breathing sessions as an adjunct to standard POTS treatment.
Objectives: The primary objective is to assess effects of RF-paced breathing on heart rate response, cardiac autonomic parameters, and symptomatology in patients with POTS. By investigating its long-term efficacy, the study seeks to determine whether RF-paced breathing can serve as a viable alternative to pharmacological treatments.
Methods: A randomized controlled trial design will be used, with participants randomly assigned to a group receiving RF-paced breathing in addition to standard treatment or to a control group. The study will measure heart rate, HRV, and POTS-related symptoms at baseline and follow-up time points.
Expected Outcomes: This study is expected to provide insights into the sustained effects of RF-paced breathing on autonomic function and POTS symptoms, with potential for establishing a non-pharmacological approach to managing the disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •All subjects were diagnosed with POTS by an experienced physician, based on the following parameters: a.
- •Sustained increase in HR of equals to or more than 30 beats/min (within the first 10 min of HUT) in the absence of orthostatic hypotension.
- •Orthostatic complaints for at least 3 months that ameliorated on return to the supine position.
- •Able to provide informed consent and adhere to the intervention schedule.
- •No prior training in resonance frequency breathing techniques.
排除标准
- •Presence of other cardiovascular, neurological, or psychiatric conditions
- •Current use of medications that significantly affect symptoms
- •Pregnancy or lactation
- •Cardiac pacemakers, severe heart failure or any other cardiovascular abnormality
- •Moderate to severe sensorimotor polyneuropathy
- •Neurodegenerative diseases
- •Uncontrolled Diabetes mellitus
- •Drug abuse
- •Untreated hyperthyroidism
- •Prolonged bed rest.
结局指标
主要结局
Change in heart rate response during the tilt table test (with and without resonance paced breathing).
时间窗: At Baseline | After 2 Weeks | After 4 Weeks (Termination of Intervention) | After 6 Weeks
Mean HR
时间窗: At Baseline | After 2 Weeks | After 4 Weeks (Termination of Intervention) | After 6 Weeks
Maximum HR
时间窗: At Baseline | After 2 Weeks | After 4 Weeks (Termination of Intervention) | After 6 Weeks
Minimum HR
时间窗: At Baseline | After 2 Weeks | After 4 Weeks (Termination of Intervention) | After 6 Weeks
次要结局
- 1. Changes in HRV parameters(2. Classical Autonomic Function Tests)
研究者
Dr Raihan Mannan
All India Institute of Medical Sciences Patna
