Post-Acute COVID-19 Syndrome Clinical Trial
— LoCoDiRe-DysOfficial title:
The Long-CoviD Patients Causal Diagnosis and Rehabilitation Randomized Feasibility Controlled Trial in Patients With Dysautonomia: the LoCoDiRe-Dys Study
| NCT number | NCT05855356 |
| Other study ID # | 22 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 1, 2023 |
| Est. completion date | March 27, 2024 |
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
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | March 27, 2024 |
| Est. primary completion date | December 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Greece | First Department of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, National and Kapodistrian University of Athens | Athens | Attica |
| Lead Sponsor | Collaborator |
|---|---|
| Evangelismos Hospital | 414 Military Hospital of Special Diseases, LONG COVID GREECE, National and Kapodistrian University of Athens |
Greece,
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 4 months | |
| Primary | Compliance, Adverse Events and Protocol Titration to examine feasibility of the trial | Process measures that will substantiate offering of the service | 4 months | |
| Secondary | 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 | checked at [0], [8] and [16] weeks | |
| Secondary | 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. | checked at [0], [8] and [16] weeks | |
| Secondary | 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 | checked at [0], [8] and [16] weeks | |
| Secondary | 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 | checked at [0], [8] and [16] weeks | |
| Secondary | 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 | checked at [0], [8] and [16] weeks | |
| Secondary | 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. | checked at [0], [8] and [16] weeks | |
| Secondary | 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 | checked at [0], [8] and [16] weeks | |
| Secondary | International Physical Activity Questionnaire | Validated measure with 27 item self reporting physical activity of the patient | checked at [0], [8] and [16] weeks | |
| Secondary | 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 | checked at [0], [8] and [16] weeks | |
| Secondary | 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 | checked at [0], [8] and [16] weeks | |
| Secondary | Cardiorespiratory exercise test | A specialized type of stress test or exercise test that measures exercise ability | checked at [0], [8] and [16] weeks | |
| Secondary | Lower Extremity Strength | Assessment of lower extremity strength using a dynamometer. | checked at [0], [8] and [16] weeks |