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临床试验/NCT06503913
NCT06503913已完成不适用

Cognitive Muscular Therapy for Patients With Long-COVID (Post COVID-19) and Breathing Pattern Disorder

University of Salford2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Change in Nijmegen Questionnaire

研究概览

简要总结

The aim of the study is to test a treatment known as "Cognitive Muscular Therapy (CMT)" for reducing breathlessness and improving autonomic function in patients with long-COVID.

详细描述

A key symptom of long-COVID is dysfunctional breathing, characterised by an alteration in the muscular and mechanical control of breathing, such as altered movement/coordination of diaphragm and ribs. Long-COVID patients also experience symptoms such as dizziness and fatigue, which have been linked to dysautonomia (dysfunction of the nervous system controlling automatic body functions). Importantly, dysautonomia is connected to alterations in breathing mechanics. Specifically, rapid breathing, high in the chest, is associated with increased activity in the fight-or-flight system and decreased activity in the rest-and-repair system. Given this link, interventions capable of improving breathing mechanics could alleviate many long-COVID symptoms. However, current breathing retraining methods lack visualisation of breathing mechanics and do not integrate a whole-body approach to improving postural control.

We have developed a clinical system which can visualise breathing mechanics in real-time, providing patients with a "window into their body". We propose to integrate this system within a new intervention, known as Cognitive Muscular Therapy (CMT). CMT integrates psychological informed physiotherapy with training to reduce overactivation of postural muscles which can interfere with the mechanics of breathing. We propose to test this combined intervention on 20 people with Long-COVD to understand if we can improve respiratory function and symptoms associated with dysautonomia. If successful, this pilot study could pave the way for large-scale studies in long-COVID

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Above 18 years old
  • Experience moderate/severe breathlessness, quantified using the Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) scale.
  • Speak and understand English sufficiently to read the information sheet and sign the consent form
  • Ability to stand without any assistive device for at least 20 minutes (to ensure sufficient capacity to complete the intervention)

排除标准

  • Dementia or other major cognitive impairment
  • BMI >32 (as increased subcutaneous fat prevents use of breathing measurement system)
  • Current smoker or smoked regularly within last 6 months
  • Any cardiorespiratory disease that requires medical intervention (except asthma management)
  • Currently receiving physiotherapy-based treatment for LC or breathing pattern disorder
  • Significant respiratory co-morbidity (e.g. COPD, uncontrolled Asthma)

研究组 & 干预措施

Treatment

Experimental

Each participant will receive seven weekly sessions of Cognitive Muscular Therapy (CMT) + Breathing Visualisation at the University of Salford from an respiratory physiotherapist. This physiotherapist will have been trained to deliver the CMT intervention and will have at least three years' experience of working with patients with respiratory disorders. Each treatment session will last 45-60 mins. The CMT intervention comprises five components: Understanding long-COVID, general relaxation, postural deconstruction, contextual triggers and functional integration. Breathing Visualisation will be integrated into session 5, 6 and 7.

干预措施: Cognitive Muscular Therapy (Behavioral)

Treatment

Experimental

Each participant will receive seven weekly sessions of Cognitive Muscular Therapy (CMT) + Breathing Visualisation at the University of Salford from an respiratory physiotherapist. This physiotherapist will have been trained to deliver the CMT intervention and will have at least three years' experience of working with patients with respiratory disorders. Each treatment session will last 45-60 mins. The CMT intervention comprises five components: Understanding long-COVID, general relaxation, postural deconstruction, contextual triggers and functional integration. Breathing Visualisation will be integrated into session 5, 6 and 7.

干预措施: Breathing visualisation (Behavioral)

结局指标

主要结局

Change in Nijmegen Questionnaire

时间窗: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)

Used to capture breathlessness symptoms associated with hyperventilation disorder. Score 0 - 60 (0 = no hyperventilation symptoms, 60 severe symptoms of hyperventilation).

次要结局

  • Change in Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) scale(Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention))
  • Change in Dyspnea-12 questionnaire(Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention))
  • Change in Composite Autonomic Symptom Score(Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention))
  • Change in Self-evaluation of breathing questionnaire(Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention))
  • Change in EQ-5D-5L(Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention))
  • Change in WHO Disability Assessment Schedule (12-item)(Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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