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临床试验/NCT07321964
NCT07321964招募中不适用

The Effect of MediYoga on Quality of Life, Blood Pressure and Heart Rate Among Patients With Atrial Fibrillation: A Randomized Controlled Trial

Herlev and Gentofte Hospital1 个研究点 分布在 1 个国家目标入组 456 人开始时间: 2025年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
456
试验地点
1
主要终点
Arrythmia-Specific Symptoms and Health-Related Quality

研究概览

简要总结

Atrial fibrillation (AF) is the most common cardiac arrythmia, associated with increased risk of stroke, heart failure, reduced quality of life (QoL), and psychological distress. This randomized controlled trial investigates the effect of MediYoga - a program incorporating deep breathing, low-intensity yoga, and meditation- on disease-specific QoL, blood pressure, and heart rate in 456 patients with paroxysmal AF. With a strong focus on sustainability, the study is fully digital: participants are recruited online, and the 12-week intervention is delivered through an application to smartphone. Additionally, the participants receive online support via Teams. Data will be collected at baseline, 3, 6, and 12 months. The primary outcome is disease specific QoL; secondary outcomes include blood pressure, heart rate, generic QoL, and psychological wellbeing.

Qualitative interviews will explore patients' experiences with the intervention.

详细描述

Atrial fibrillation (AF) is the most common cardiac arrythmia, affecting approximately 3% of the adult population. AF is associated with substantial morbidity including increased risk of stroke and heart failure, and increased mortality risk. The risk of developing AF raises with age hence the prevalence of AF is expected to increase substantially in the future, due to increased average life expectancy. The costs from diagnostics, treatments, and in- and out-patient care, is likewise estimated to increase, because of the expanding proportion of old-er individuals, development of treatment options, and intensifying search for undiagnosed AF. Risk factors such as hypertension, coronary artery disease, obesity, type 2 diabetes, stress, alcohol overconsumption, smoking, and sleep apnea are also increasing in prevalence and are potent contributors to the development and progression of AF.

Various symptoms can occur during an AF episode, including dizziness, heart palpitations, chest pain, and fatigue. Standard treatment of AF include rhythm- and/or rate-control medications, electrical cardioversion, and in some cases catheter ablation. The treatment focuses on re-ducing symptoms and improving quality of life (QoL).

AF episodes can have negative impact on patient's physical and mental health, as well as so-cial life. Individuals with AF often report poorer QoL, and experience symptoms of stress, depression, and anxiety. Guidelines recommend self-care programs that reduce symptoms and enhance QoL and recommends regularly physical activity to improve overall cardiovascular health. Yoga has been shown to improve health-related quality of life (HRQoL), reduce blood pressure and heart rate, and reduce AF episodes in small studies in-cluding individuals with paroxysmal AF. MediYoga originates from Kundalini Yoga, and is based on deep breathing, combined with slow movements, meditation, and relaxation exercises. MediYoga is designed so that many of the exercises can be performed while seated.

The increasing proportion of older individuals living with AF, demands new ways of organizing and implement rehabilitation for patients. Tele-health, defined as the delivery of health-related services through digital communication technologies is eligible to provide yoga classes at home. Online interventions might increase the likelihood that participants complete the program, as it can be done in their own surroundings without required transportation. Remote recruitment has increasing potential, as it enhances the possibility to include participants from rural districts, who might not participate in onsite rehabilitation, due to the long distance to a rehabilitation center.

To our knowledge, this study is the first study to investigate the effect of an online yoga intervention for patients with symptomatic paroxysmal AF, using a complete online recruitment and implementation strategy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Aged 18 and above
  • Diagnosed with paroxysmal atrial fibrillation
  • EHRA score at 2 or more
  • Owner of a smartphone or tablet
  • Speaking and reading Danish
  • No comorbidity that restricts them from participating in the intervention

排除标准

  • Elevated TSH Hormone
  • Participated in mindfulness or yoga exercise regularly at any point during the last two years.

研究组 & 干预措施

Intervention Group I, yoga 20 minutes x3 pr week

Experimental

干预措施: Yoga 20 minutes (Behavioral)

Intervention group II, yoga 60 minutes x1 pr week

Experimental

干预措施: Yoga 60 minutes (Behavioral)

Control group

No Intervention

Treatment as usual

结局指标

主要结局

Arrythmia-Specific Symptoms and Health-Related Quality

时间窗: Baseline, and at 3 and 6 months after enrollment

The validated form is divided into three parts: (1) evaluation of the most recent episode of arrythmia and current medication (2) assessment of symptom burden, including a 9-point symptom scale (ASTA symptom scale) with a 4-point response scale, and (3) assessment of the HRQoL using a 13-point scale (ASTA scale) with the same 4-point response scale as the symptom scale. The ASTA scale is further divided into a physical and a mental subscale. Scores range from 0 to 100, with higher scores reflecting a higher symptom burden and a worse impact on HRQoL due to arrythmia

次要结局

  • Health-Related Quality of Life(Baseline, and at 3 and 6 months after enrollment)
  • Mental health(Baseline, and at 3 and 6 months after enrollment)
  • Blood pressure(Baseline, and at 3 and 6 months after enrollment)
  • Pulse(At baseline, and 3 and 6 months after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Signe Stelling Risom

Associate Professor, PhD, RN, Senior Researcher

Herlev and Gentofte Hospital

研究点 (1)

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