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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
respiratory physiotherapy, personalized aerobic and strength training
Behavioural and Medical management
First Department of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, National and Kapodistrian University of Athens
Athens, Attica, Greece
RECRUITINGNumber 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
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