search
Back to results

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

Primary Purpose

Post-Acute COVID-19 Syndrome, Dysautonomia

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Rehabilitation
Standard of Care
Sponsored by
Evangelismos Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-Acute COVID-19 Syndrome focused on measuring Long Covid, Post Covid-19 condition, Rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LoCoDiRe-Dys

Standard of Care

Arm Description

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

Standard of care including behavioural and medical advice

Outcomes

Primary Outcome Measures

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
Compliance, Adverse Events and Protocol Titration to examine feasibility of the trial
Process measures that will substantiate offering of the service

Secondary Outcome Measures

10 minutes NASA Lean Test
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
Six minute Walk Test
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.
1 minute sit to stand test
Validated measure to record the times standing up from a chair, closely related with cardiorespiratory capacity and lower limb strength
Fatigue Severity Scale
Validated measure to record fatigue severity as reported by the patient, 9 statements each in a scale of 1-7, min 9 max 63
modified Medical Research Council Dyspnea Scale
Validated measure to record functional disability because of dyspnea as reported by the patient in a scale 0-4
Nijmegen Questionnaire
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.
Montreal Cognitive Assessment
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
International Physical Activity Questionnaire
Validated measure with 27 item self reporting physical activity of the patient
Hospital Anxiety and Depression Scale
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
EuroQoL 5 Dimensions 5 Levels
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
Cardiorespiratory exercise test
A specialized type of stress test or exercise test that measures exercise ability
Lower Extremity Strength
Assessment of lower extremity strength using a dynamometer.

Full Information

First Posted
May 8, 2023
Last Updated
May 9, 2023
Sponsor
Evangelismos Hospital
Collaborators
National and Kapodistrian University of Athens, LONG COVID GREECE, 414 Military Hospital of Special Diseases
search

1. Study Identification

Unique Protocol Identification Number
NCT05855356
Brief Title
Post Covid-19 Dysautonomia Rehabilitation Randomized Controlled Trial
Acronym
LoCoDiRe-Dys
Official Title
The Long-CoviD Patients Causal Diagnosis and Rehabilitation Randomized Feasibility Controlled Trial in Patients With Dysautonomia: the LoCoDiRe-Dys Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Evangelismos Hospital
Collaborators
National and Kapodistrian University of Athens, LONG COVID GREECE, 414 Military Hospital of Special Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Acute COVID-19 Syndrome, Dysautonomia
Keywords
Long Covid, Post Covid-19 condition, Rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
unblinded randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LoCoDiRe-Dys
Arm Type
Experimental
Arm Description
Respiratory physiotherapy, personalized aerobic and strength training in parallel with standard of care
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of care including behavioural and medical advice
Intervention Type
Procedure
Intervention Name(s)
Rehabilitation
Intervention Description
respiratory physiotherapy, personalized aerobic and strength training
Intervention Type
Procedure
Intervention Name(s)
Standard of Care
Intervention Description
Behavioural and Medical management
Primary Outcome Measure Information:
Title
Number of patients with lack of definite Dysautonomia Diagnosis
Description
Ewing Battery is a validated instrument to diagnose dysautonomia, with a definite diagnosis when 2 out of 4 heart rate tests are abnormal
Time Frame
4 months
Title
Compliance, Adverse Events and Protocol Titration to examine feasibility of the trial
Description
Process measures that will substantiate offering of the service
Time Frame
4 months
Secondary Outcome Measure Information:
Title
10 minutes NASA Lean Test
Description
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
Time Frame
checked at [0], [8] and [16] weeks
Title
Six minute Walk Test
Description
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.
Time Frame
checked at [0], [8] and [16] weeks
Title
1 minute sit to stand test
Description
Validated measure to record the times standing up from a chair, closely related with cardiorespiratory capacity and lower limb strength
Time Frame
checked at [0], [8] and [16] weeks
Title
Fatigue Severity Scale
Description
Validated measure to record fatigue severity as reported by the patient, 9 statements each in a scale of 1-7, min 9 max 63
Time Frame
checked at [0], [8] and [16] weeks
Title
modified Medical Research Council Dyspnea Scale
Description
Validated measure to record functional disability because of dyspnea as reported by the patient in a scale 0-4
Time Frame
checked at [0], [8] and [16] weeks
Title
Nijmegen Questionnaire
Description
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.
Time Frame
checked at [0], [8] and [16] weeks
Title
Montreal Cognitive Assessment
Description
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
Time Frame
checked at [0], [8] and [16] weeks
Title
International Physical Activity Questionnaire
Description
Validated measure with 27 item self reporting physical activity of the patient
Time Frame
checked at [0], [8] and [16] weeks
Title
Hospital Anxiety and Depression Scale
Description
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
Time Frame
checked at [0], [8] and [16] weeks
Title
EuroQoL 5 Dimensions 5 Levels
Description
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
Time Frame
checked at [0], [8] and [16] weeks
Title
Cardiorespiratory exercise test
Description
A specialized type of stress test or exercise test that measures exercise ability
Time Frame
checked at [0], [8] and [16] weeks
Title
Lower Extremity Strength
Description
Assessment of lower extremity strength using a dynamometer.
Time Frame
checked at [0], [8] and [16] weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonios Kontaxakis
Phone
+306947468724
Email
akontaxakis@yahoo.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitrios Spaggoulakis
Email
dimitrisspglks@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paraskevi Katsaounou
Organizational Affiliation
Director of the Lond Covid Outpatient Clinic
Official's Role
Study Director
Facility Information:
Facility Name
First Department of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, National and Kapodistrian University of Athens
City
Athens
State/Province
Attica
ZIP/Postal Code
106 76
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paraskevi Katsaounou, PhD
Email
paraskevikatsaounou@gmail.com
First Name & Middle Initial & Last Name & Degree
Andreas Assimakos, PhD
Email
silverakos@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
35853576
Citation
Ormiston CK, Swiatkiewicz I, Taub PR. Postural orthostatic tachycardia syndrome as a sequela of COVID-19. Heart Rhythm. 2022 Jul 16;19(11):1880-9. doi: 10.1016/j.hrthm.2022.07.014. Online ahead of print.
Results Reference
background
PubMed Identifier
32145864
Citation
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.
Results Reference
background
PubMed Identifier
35743774
Citation
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.
Results Reference
background

Learn more about this trial

Post Covid-19 Dysautonomia Rehabilitation Randomized Controlled Trial

We'll reach out to this number within 24 hrs