Post Covid-19 Dysautonomia Rehabilitation Randomized Controlled Trial

NCT05855356 | Unknown DMC

• 1 other identifier: 22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Long Covid; Post Covid-19 condition; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Number of patients with lack of definite Dysautonomia Diagnosis

  Ewing Battery is a validated instrument to diagnose dysautonomia, with a definite diagnosis when 2 out of 4 heart rate tests are abnormal

  4 months

• Compliance, Adverse Events and Protocol Titration to examine feasibility of the trial

  Process measures that will substantiate offering of the service

  4 months

Secondary Outcomes (12)

• 10 minutes NASA Lean Test

  checked at [0], [8] and [16] weeks

• Six minute Walk Test

  checked at [0], [8] and [16] weeks

• 1 minute sit to stand 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

Study Arms (2)

LoCoDiRe-Dys

EXPERIMENTAL

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

Procedure: Rehabilitation; Procedure: Standard of Care

Standard of Care

ACTIVE COMPARATOR

Standard of care including behavioural and medical advice

Procedure: Standard of Care

Interventions

Rehabilitation PROCEDURE

respiratory physiotherapy, personalized aerobic and strength training

LoCoDiRe-Dys

Standard of Care PROCEDURE

Behavioural and Medical management

LoCoDiRe-Dys; Standard of Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Evangelismos Hospital: lead
• National and Kapodistrian University of Athens: collaborator
• LONG COVID GREECE: collaborator
• 414 Military Hospital of Special Diseases: collaborator

Study Sites (1)

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

Athens, Attica, 106 76, Greece

RECRUITING

Related Publications (3)

• Ormiston CK, Swiatkiewicz I, Taub PR. Postural orthostatic tachycardia syndrome as a sequela of COVID-19. Heart Rhythm. 2022 Nov;19(11):1880-1889. doi: 10.1016/j.hrthm.2022.07.014. Epub 2022 Jul 16.

  PMID: 35853576 BACKGROUND

• Raj SR, Guzman JC, Harvey P, Richer L, Schondorf R, Seifer C, Thibodeau-Jarry N, Sheldon RS. Canadian Cardiovascular Society Position Statement on Postural Orthostatic Tachycardia Syndrome (POTS) and Related Disorders of Chronic Orthostatic Intolerance. Can J Cardiol. 2020 Mar;36(3):357-372. doi: 10.1016/j.cjca.2019.12.024.

  PMID: 32145864 BACKGROUND

• Katsarou MS, Iasonidou E, Osarogue A, Kalafatis E, Stefanatou M, Pappa S, Gatzonis S, Verentzioti A, Gounopoulos P, Demponeras C, Konstantinidou E, Drakoulis N, Asimakos A, Antonoglou A, Mavronasou A, Spetsioti S, Kotanidou A, Katsaounou P. The Greek Collaborative Long COVID Study: Non-Hospitalized and Hospitalized Patients Share Similar Symptom Patterns. J Pers Med. 2022 Jun 17;12(6):987. doi: 10.3390/jpm12060987.

  PMID: 35743774 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Autonomic Nervous System Diseases

Interventions

Rehabilitation; Standard of Care

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Paraskevi Katsaounou

  Director of the Lond Covid Outpatient Clinic

  STUDY DIRECTOR

Central Study Contacts

Antonios Kontaxakis

CONTACT

+306947468724; akontaxakis@yahoo.gr

Dimitrios Spaggoulakis

CONTACT

dimitrisspglks@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PM&R Consultant

Model Details: unblinded randomized controlled trial

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 11, 2023
• Study Start: February 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: March 27, 2024
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 3 months after completion of the study, for 5 years on
• Access Criteria: Request reasons clearly stated- Sharing of further analysis plan

Locations

GR (1)