An interventional study of Rehabilitation and Standard of Care in Post-Acute COVID-19 Syndrome and Dysautonomia, sponsored by Evangelismos Hospital. Recruiting at 1 site in Greece. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by Evangelismos Hospital · Not applicable, Interventional, and Supportive care
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
604 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 416 interventional studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →Evangelismos Hospital is the lead sponsor of 29 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Respiratory physiotherapy, personalized aerobic and strength training in parallel with standard of care
Procedure: Rehabilitation · Procedure: Standard of Care
Standard of care including behavioural and medical advice
Procedure: Standard of Care
respiratory physiotherapy, personalized aerobic and strength training
Behavioural and Medical management
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
Time frame: 4 months
Compliance, Adverse Events and Protocol Titration to examine feasibility of the trial
Process measures that will substantiate offering of the service
Time frame: 4 months
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: checked at [0], [8] and [16] weeks
International Physical Activity Questionnaire
Validated measure with 27 item self reporting physical activity of the patient
Time frame: 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
Time frame: 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
Time frame: checked at [0], [8] and [16] weeks
Cardiorespiratory exercise test
A specialized type of stress test or exercise test that measures exercise ability
Time frame: checked at [0], [8] and [16] weeks
Lower Extremity Strength
Assessment of lower extremity strength using a dynamometer.
Time frame: checked at [0], [8] and [16] weeks
Plan to share: Yes — Anonymized clinical data
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, 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
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