Post Covid-19 Dysautonomia Rehabilitation Randomized Controlled Trial (LoCoDiRe-Dys)

Evangelismos Hospital

Status: Enrolling

Conditions: Post-Acute COVID-19 Syndrome; Dysautonomia

Treatments: Procedure: Rehabilitation; Procedure: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05855356

22

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

LoCoDiRe-Dys

Experimental group

Description:

Respiratory physiotherapy, personalized aerobic and strength training in parallel with standard of care

Treatment:

Procedure: Rehabilitation

Procedure: Standard of Care

Standard of Care

Active Comparator group

Description:

Standard of care including behavioural and medical advice

Treatment:

Procedure: Standard of Care