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

May 9, 2023 updated by: Antonios Kontaxakis, Evangelismos Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 106 76
        • Recruiting
        • First Department of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, National and Kapodistrian University of Athens
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LoCoDiRe-Dys
Respiratory physiotherapy, personalized aerobic and strength training in parallel with standard of care
Procedure: Rehabilitation
respiratory physiotherapy, personalized aerobic and strength training
Procedure: Standard of Care
Behavioural and Medical management
Active Comparator: Standard of Care
Standard of care including behavioural and medical advice
Procedure: Standard of Care
Behavioural and Medical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with lack of definite Dysautonomia Diagnosis
Time Frame: 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
4 months
Compliance, Adverse Events and Protocol Titration to examine feasibility of the trial
Time Frame: 4 months
Process measures that will substantiate offering of the service
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 minutes NASA Lean Test
Time Frame: checked at [0], [8] and [16] weeks
Validated measure to record orthostatic intolerance, recording of blood pressure and heart rate in 5 min supine position, and every minute when standing up till 10 min
checked at [0], [8] and [16] weeks
Six minute Walk Test
Time Frame: checked at [0], [8] and [16] weeks
Validated measure, a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
checked at [0], [8] and [16] weeks
1 minute sit to stand test
Time Frame: checked at [0], [8] and [16] weeks
Validated measure to record the times standing up from a chair, closely related with cardiorespiratory capacity and lower limb strength
checked at [0], [8] and [16] weeks
Fatigue Severity Scale
Time Frame: checked at [0], [8] and [16] weeks
Validated measure to record fatigue severity as reported by the patient, 9 statements each in a scale of 1-7, min 9 max 63
checked at [0], [8] and [16] weeks
modified Medical Research Council Dyspnea Scale
Time Frame: checked at [0], [8] and [16] weeks
Validated measure to record functional disability because of dyspnea as reported by the patient in a scale 0-4
checked at [0], [8] and [16] weeks
Nijmegen Questionnaire
Time Frame: checked at [0], [8] and [16] weeks
Validated measure to record dysfunctional breathing as recorded by the patient with each statement valued 0-4, with A score of over 23 out of 64 suggest a positive diagnosis of hyperventilation syndrome.
checked at [0], [8] and [16] weeks
Montreal Cognitive Assessment
Time Frame: checked at [0], [8] and [16] weeks
Validated measure for rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation, with a normal score over 25/30
checked at [0], [8] and [16] weeks
International Physical Activity Questionnaire
Time Frame: checked at [0], [8] and [16] weeks
Validated measure with 27 item self reporting physical activity of the patient
checked at [0], [8] and [16] weeks
Hospital Anxiety and Depression Scale
Time Frame: checked at [0], [8] and [16] weeks
Validated measure, a 14-item measure designed to assess anxiety and depression symptoms in medical patients. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case
checked at [0], [8] and [16] weeks
EuroQoL 5 Dimensions 5 Levels
Time Frame: checked at [0], [8] and [16] weeks
Validated measure, a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
checked at [0], [8] and [16] weeks
Cardiorespiratory exercise test
Time Frame: checked at [0], [8] and [16] weeks
A specialized type of stress test or exercise test that measures exercise ability
checked at [0], [8] and [16] weeks
Lower Extremity Strength
Time Frame: checked at [0], [8] and [16] weeks
Assessment of lower extremity strength using a dynamometer.
checked at [0], [8] and [16] weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evangelismos Hospital

Collaborators

National and Kapodistrian University of Athens
LONG COVID GREECE
414 Military Hospital of Special Diseases

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

March 27, 2024

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized clinical data

IPD Sharing Time Frame

3 months after completion of the study, for 5 years on

IPD Sharing Access Criteria

Request reasons clearly stated- Sharing of further analysis plan

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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