Official Title
The Long-CoviD Patients Causal Diagnosis and Rehabilitation Randomized Feasibility Controlled Trial in Patients With Dysautonomia: the LoCoDiRe-Dys Study
Brief Summary

Dysautonomia in post-covid-19 condition appears to affect a significant number ofpatients, with reports raising the incidence up to 61%, having an overlap with myalgicencephalomyelitis/ chronic fatigue syndrome. Quality of life and daily function issignificantly impacted and conservative management interventions, despite the lack ofhigh quality evidence up to now, are needed to ameliorate disability. 50 adults with adysautonomia post-covid-19 diagnosis based on the Ewing battery and a NASA lean test willbe 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 exercisetest indicators. Safety and acceptance will also be checked, primarily excludingparticipants with post exertional malaise. The Long-CoViD patients Causal Diagnosis andRehabilitation study in patients with Dysautonomia (LoCoDiRE-Dys) study intervention willconsist of an educational module, breathing retraining and an individualized exerciseintervention 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 withdysautonomia offering a multimodal intervention both in diagnosis and management

Detailed Description

Not Provided

Recruiting
Post-acute COVID-19 Syndrome
Dysautonomia

Procedure: Rehabilitation

respiratory physiotherapy, personalized aerobic and strength training

Procedure: Standard of Care

Behavioural and Medical management

Eligibility Criteria

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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
Greece
Locations

First Department of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, National and Kapodistrian University of Athens
Athens, Attica, Greece

Investigator: Paraskevi Katsaounou, PhD
paraskevikatsaounou@gmail.com

Contacts

Antonios Kontaxakis
+306947468724
akontaxakis@yahoo.gr

Dimitrios Spaggoulakis
dimitrisspglks@gmail.com

Paraskevi Katsaounou, Study Director
Director of the Lond Covid Outpatient Clinic

Evangelismos Hospital
NCT Number
Keywords
long COVID
Post covid-19 condition
Rehabilitation
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome
Autonomic Nervous System Diseases
Primary Dysautonomias