跳至主要内容
临床试验/CTRI/2025/07/091338
CTRI/2025/07/091338尚未招募不适用

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

AIIMS Patna1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年8月1日最近更新:

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

发起方
AIIMS Patna
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Raihan Mannan

All India Institute of Medical Sciences Patna

研究点 (1)

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