The Long-CoviD Patients Causal Diagnosis and Rehabilitation Randomized Feasibility Controlled Trial in Patients With Dysautonomia: the LoCoDiRe-Dys Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of patients with lack of definite Dysautonomia Diagnosis
研究概览
简要总结
Dysautonomia in post-covid-19 condition appears to affect a significant number of patients, with reports raising the incidence up to 61%, having an overlap with myalgic encephalomyelitis/ chronic fatigue syndrome. Quality of life and daily function is significantly impacted and conservative management interventions, despite the lack of high quality evidence up to now, are needed to ameliorate disability. 50 adults with a dysautonomia post-covid-19 diagnosis based on the Ewing battery and a NASA lean test will be enrolled in a randomized single blinded controlled trial with a crossover design. Feasibility and lack of definite dysautonomia diagnosis will be the primary out-comes, while secondary outcomes will be health-related, clinical and cardiopulmonary exercise test indicators. Safety and acceptance will also be checked, primarily excluding participants with post exertional malaise. The Long-CoViD patients Causal Diagnosis and Rehabilitation study in patients with Dysautonomia (LoCoDiRE-Dys) study intervention will consist of an educational module, breathing retraining and an individualized exercise intervention of biweekly sessions for two months with regular assessment of both groups. LoCoDiRe- Dys aims to be the first post-covid-19 randomized study in people with dysautonomia offering a multimodal intervention both in diagnosis and management
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
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-65 years of age
- •WHO definition of post covid-19 condition
- •Confirmed dysautonomia diagnosis through Ewing Battery
- •Able to attend 2 times/ week for 8 weeks
- •Able to provide informed consent
排除标准
- •Absolute or relative contra-indications to exercise due to cardiac pathology
- •Serious mental/ cognitive impairment that will not allow systematic participation
- •Unable to regularly reach the center
- •Pregnancy
- •CFS/ME fulfilling the Canadian Consensus Criteria
- •Secondary health conditions that would explain symptoms, intervene in dysautonomia diagnosis or would impede participation in the exercise protocol (i.e. , untreated hypothyroidism and Diabetes Melitus, major psychiatric disorders, COPD, PICS, Pulmonary Fibrosis, chronic respiratory or heart failure, not ambulatory, suffering from dementia, chronically paralyzed, with paraplegia, with multiple injuries or other serious orthopedic problems that caused disability, patients suffering from very serious underlying diseases such as end-stage cancer, and those with neurological diseases causing disability)
结局指标
主要结局
Number of patients with lack of definite Dysautonomia Diagnosis
时间窗: 4 months
Ewing Battery is a validated instrument to diagnose dysautonomia, with a definite diagnosis when 2 out of 4 heart rate tests are abnormal
Compliance, Adverse Events and Protocol Titration to examine feasibility of the trial
时间窗: 4 months
Process measures that will substantiate offering of the service
次要结局
- 1 minute sit to stand test(checked at [0], [8] and [16] weeks)
- 10 minutes NASA Lean Test(checked at [0], [8] and [16] weeks)
- Six minute Walk Test(checked at [0], [8] and [16] weeks)
- Fatigue Severity Scale(checked at [0], [8] and [16] weeks)
- modified Medical Research Council Dyspnea Scale(checked at [0], [8] and [16] weeks)
- Nijmegen Questionnaire(checked at [0], [8] and [16] weeks)
- International Physical Activity Questionnaire(checked at [0], [8] and [16] weeks)
- EuroQoL 5 Dimensions 5 Levels(checked at [0], [8] and [16] weeks)
- Cardiorespiratory exercise test(checked at [0], [8] and [16] weeks)
- Montreal Cognitive Assessment(checked at [0], [8] and [16] weeks)
- Hospital Anxiety and Depression Scale(checked at [0], [8] and [16] weeks)
- Lower Extremity Strength(checked at [0], [8] and [16] weeks)
研究者
Antonios Kontaxakis
PM&R Consultant
Evangelismos Hospital