Post-Acute COVID-19 SyndromeLoCoDiRe-DysNCT05855356
Post Covid-19 Dysautonomia Rehabilitation Randomized Controlled Trial
A study testing Rehabilitation in people with Post-Acute COVID-19 Syndrome and Dysautonomia, run by Evangelismos Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Acute COVID-19 Syndrome, Dysautonomia
- What is being tested?
- Rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2023to 27 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Dimitrios Spaggoulakis contact
Greece1 site, 1 recruiting
- Recruiting
First Department of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, National and Kapodistrian University of Athens
Athens, Attica, 106 76
Paraskevi Katsaounou, PhD, paraskevikatsaounou@gmail.com
Andreas Assimakos, PhD, silverakos@gmail.com
About this study
Official title: 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
- Conditions
- Post-Acute COVID-19 Syndrome, Dysautonomia
- Being tested
- Rehabilitation, Standard of Care
- Keywords
- Long Covid, Post Covid-19 condition, Rehabilitation
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationProcedure or surgery
respiratory physiotherapy, personalized aerobic and strength training
Standard of CareProcedure or surgery
Behavioural and Medical management
| Study group | Role | What they receive |
|---|---|---|
| LoCoDiRe-Dys | Experimental | Respiratory physiotherapy, personalized aerobic and strength training in parallel with standard of care Receives: Procedure: Rehabilitation; Procedure: Standard of Care |
| Standard of Care | Active comparator | Standard of care including behavioural and medical advice Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Compliance, Adverse Events and Protocol Titration to examine feasibility of the trial
Process measures that will substantiate offering of the service
Measured: 4 months
Secondary outcomes (12)
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
Measured: checked at [0], [8] and [16] weeks
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.
Measured: checked at [0], [8] and [16] weeks
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
Measured: checked at [0], [8] and [16] weeks
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
Measured: checked at [0], [8] and [16] weeks
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
Measured: checked at [0], [8] and [16] weeks
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.
Measured: checked at [0], [8] and [16] weeks
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
Measured: checked at [0], [8] and [16] weeks
International Physical Activity Questionnaire
Validated measure with 27 item self reporting physical activity of the patient
Measured: checked at [0], [8] and [16] weeks
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
Measured: checked at [0], [8] and [16] weeks
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
Measured: checked at [0], [8] and [16] weeks
Cardiorespiratory exercise test
A specialized type of stress test or exercise test that measures exercise ability
Measured: checked at [0], [8] and [16] weeks
Lower Extremity Strength
Assessment of lower extremity strength using a dynamometer.
Measured: checked at [0], [8] and [16] weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Feb 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion27 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- unblinded randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evangelismos Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, LONG COVID GREECE, 414 Military Hospital of Special Diseases
- Responsible party
- Principal investigator, Antonios Kontaxakis, Evangelismos Hospital
- Investigators
- Paraskevi Katsaounou, Study director, Director of the Lond Covid Outpatient Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855356
- Sponsor's protocol ID
- 22
- Acronym
- LoCoDiRe-Dys
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized clinical data
Publications
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.
PubMed 35853576Raj 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.
PubMed 32145864Katsarou 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.
PubMed 35743774
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-CoviD Patients Causal Diagnosis and Rehabilitation Randomized Feasibility Controlled Trial in Patients With Dysautonomia: the LoCoDiRe-Dys Study
- ClinicalTrials.gov ID
- NCT05855356
- Acronym / sponsor ID
- LoCoDiRe-Dys / 22
- Conditions
- Post-Acute COVID-19 Syndrome, Dysautonomia
- Keywords
- Long Covid, Post Covid-19 condition, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Evangelismos HospitalUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, LONG COVID GREECE, 414 Military Hospital of Special Diseases
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 27 Mar 2024 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- unblinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| LoCoDiRe-Dys | Experimental | Procedure: Rehabilitation, Procedure: Standard of CareRespiratory physiotherapy, personalized aerobic and strength training in parallel with standard of care |
| Standard of Care | Active comparator | Procedure: Standard of CareStandard of care including behavioural and medical advice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitationrespiratory physiotherapy, personalized aerobic and strength training | Procedure or surgery | LoCoDiRe-Dys |
| Standard of CareBehavioural and Medical management | Procedure or surgery | LoCoDiRe-Dys, Standard of Care |
Primary outcome
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
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
12 secondary outcomes
10 minutes NASA Lean Test
Time frame: checked at [0], [8] and [16] weeks
Six minute Walk Test
Time frame: checked at [0], [8] and [16] weeks
1 minute sit to stand test
Time frame: checked at [0], [8] and [16] weeks
Fatigue Severity Scale
Time frame: checked at [0], [8] and [16] weeks
modified Medical Research Council Dyspnea Scale
Time frame: checked at [0], [8] and [16] weeks
Nijmegen Questionnaire
Time frame: checked at [0], [8] and [16] weeks
Montreal Cognitive Assessment
Time frame: checked at [0], [8] and [16] weeks
International Physical Activity Questionnaire
Time frame: checked at [0], [8] and [16] weeks
Hospital Anxiety and Depression Scale
Time frame: checked at [0], [8] and [16] weeks
EuroQoL 5 Dimensions 5 Levels
Time frame: checked at [0], [8] and [16] weeks
Cardiorespiratory exercise test
Time frame: checked at [0], [8] and [16] weeks
Lower Extremity Strength
Time frame: checked at [0], [8] and [16] weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Background: PubMed 35853576Ormiston 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.
- Background: PubMed 32145864Raj 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.
- Background: PubMed 35743774Katsarou 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.
- Individual participant dataSharing planned: Yes. Anonymized clinical data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Spaggoulakis contact
Paraskevi Katsaounou study director
Director of the Lond Covid Outpatient Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Post-Acute COVID-19 Syndrome and Dysautonomia, run by Evangelismos Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonios Kontaxakis (+306947468724, akontaxakis@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with lack of definite Dysautonomia Diagnosis (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05855356, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.