Clinical trial NCT05855356: Post Covid-19 Dysautonomia Rehabilitation Randomized Controlled Trial
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
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Acute COVID-19 Syndrome
Dysautonomia
Keywords: Long Covid
Post Covid-19 condition
Rehabilitation
Lead sponsor: Evangelismos Hospital
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
name: LONG COVID GREECE
name: 414 Military Hospital of Special Diseases
First posted: 2023-05-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: unblinded randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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


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)

Primary outcomes:
measure: Number of patients with lack of definite Dysautonomia Diagnosis
timeFrame: 4 months
measure: Compliance, Adverse Events and Protocol Titration to examine feasibility of the trial
timeFrame: 4 months
Secondary outcomes:
measure: 10 minutes NASA Lean Test
timeFrame: checked at [0], [8] and [16] weeks
measure: Six minute Walk Test
timeFrame: checked at [0], [8] and [16] weeks
measure: 1 minute sit to stand test
timeFrame: checked at [0], [8] and [16] weeks
measure: Fatigue Severity Scale
timeFrame: checked at [0], [8] and [16] weeks
measure: modified Medical Research Council Dyspnea Scale
timeFrame: checked at [0], [8] and [16] weeks
measure: Nijmegen Questionnaire
timeFrame: checked at [0], [8] and [16] weeks
measure: Montreal Cognitive Assessment
timeFrame: checked at [0], [8] and [16] weeks
measure: International Physical Activity Questionnaire
timeFrame: checked at [0], [8] and [16] weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: checked at [0], [8] and [16] weeks
measure: EuroQoL 5 Dimensions 5 Levels
timeFrame: checked at [0], [8] and [16] weeks
measure: Cardiorespiratory exercise test
timeFrame: checked at [0], [8] and [16] weeks
measure: Lower Extremity Strength
timeFrame: checked at [0], [8] and [16] weeks
Other outcomes:
Locations:
city: Athens
country: Greece
facility: First Department of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, National and Kapodistrian University of Athens
state: Attica
Study officials:
affiliation: Director of the Lond Covid Outpatient Clinic
name: Paraskevi Katsaounou
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.