Post Covid-19 Dysautonomia Rehabilitation Randomized Controlled Trial

Summary

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

Conditions

• Post-Acute COVID-19 Syndrome
• Dysautonomia

Interventions

PROCEDURE

Rehabilitation

respiratory physiotherapy, personalized aerobic and strength training

PROCEDURE

Standard of Care

Behavioural and Medical management

Sponsors & Collaborators

• National and Kapodistrian University of Athens

  collaborator OTHER

• LONG COVID GREECE

  collaborator UNKNOWN

• 414 Military Hospital of Special Diseases

  collaborator UNKNOWN

• Evangelismos Hospital

  lead OTHER

Principal Investigators

• Paraskevi Katsaounou · Director of the Lond Covid Outpatient Clinic

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-01

Primary Completion

2023-12-30

Completion

2024-03-27

Countries

• Greece

Study Locations