Covid19_rehabilitation Clinical Trial
Official title:
Recovery Profiles in Patients With COVID-19 Outcomes Undergoing Rehabilitation
COVID19 patients survivors, after discharge from hospital show reduced lung function and reduced ability to exercise. Furthermore, mental health problems including stress, anxiety and depression and a low quality of life were observed. The prospective observational study involves COVID19 patients who have needed rehabilitation at the University Hospital of Ferrara. Patients receive comprehensive rehabilitation based on their specific needs in both acute and subacute rehabilitation. At the end of hospital rehabilitation, patients are offered a program to be carried out at home for both physical and psychological problems. A range of demographic and clinical data will be collected. Patients will also undergo a battery of functional, cognitive and psychological tests at 12, 26 and 52 weeks from the infection onset. Moreover, a specific assessement (both clinical and instrumental) on the pain symptom experienced, where present, will be done.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | November 30, 2023 |
| Est. primary completion date | June 30, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - diagnosis of covid19 (WHO criteria); - indication for respiratory and / or neuromotor rehabilitation treatment Exclusion Criteria: - cognitive or communication impairment precluding informed consent - severe medical conditions - pregnancy |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Department of Neuroscience and Rehabilitation, University Hospital of Ferrara | Ferrara | Emilia Romagna |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital of Ferrara |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Borg scale | Rating perceived exertion on a 10-points scale in which higher values correspond to havier symptomps. | At the beginning of early rehabilitation | |
| Primary | Heart rate | Heart rate in sitting and standing positions. | At the beginning of early rehabilitation | |
| Primary | Oxygen saturation | Oxygen saturation in sitting and standing positions. | At the beginning of early rehabilitation | |
| Primary | 30 seconds sit-to-stand test | To measure the strength of the lower limbs. | At the beginning of early rehabilitation | |
| Primary | Change in 1 minute sit-to-stand test between two time points | To measure the strength of the lower limbs. | Month 3, Month 6 | |
| Primary | Change in Short form health survey between three time points | Is a general health questionnaire for the assessment of the patient's quality of life. Two summary scores are reported: a mental component score and a physical component score. The scores may be reported as Z-scores. | At the beginning of early rehabilitation, Month 3, Month 6 | |
| Primary | 2-minute walking test | For mobility assessment | At the beginning of early rehabilitation | |
| Primary | Change in 6-minute walking test between two time points | For mobility assessment | Month 3, Month 6 | |
| Primary | Change in Functional Independence Measure Scale between two time points | Evaluate the functional autonomy of the patient both on the motor and cognitive side (minumum score:18 maximum score:126 ). At 3 months the "FIM efficiency" is evaluated as a measure of the efficiency of the rehabilitation intervention. | At the beginning of early rehabilitation, Month 3 | |
| Primary | Change in Montreal Cognitive Assessment (MoCA) between two time points | Cognitive screening test. Higher scores (0-30) are related to a better performance. | Month 3, Month 6 | |
| Primary | Cognitive Reserve Index questionnaire | For measuring cognitive reserve. It comprehends a overall evaluation of the subject's cognitive status based on social and personal data. Higher scores underline major cognitive reserves. | Month 3 | |
| Primary | Change in Patient Health Questionnaire-9 (PHQ-9) between two time points | To identify the presence of depression and measure its severity. Score goes from 0 to 27 in which higer numbers represent worse clinical outcomes. | Month 3, Month 6 | |
| Primary | Change in Beck Anxiety Inventory (BAI) between two time points | To measure the severity of anxiety. Higher scores (0-63) indicates more severe anxiety symptoms | Month 3, Month 6 | |
| Primary | Change in Connor-Davidson Resilience Scale between two time points | To measure the resilience. Total score goes from 0 to 40, higher points mean greater resilience. | Month 3, Month 6 | |
| Primary | Change in Impact of Event Scale - Revised between two time points | To measure the amount of distress that associate with a specific event. Total score varies from 0 to 88, higher scores indicate greater post-event distress. | Month 3, Month 6 | |
| Primary | Change in General Self Efficacy Scale between two time points | To assess how much people believe they can achieve their goals, despite difficulties. Total score could be from 4 to 40, higher results show larger self efficacy perception. | Month 3, Month 6 | |
| Primary | Change in Pittsburgh Sleep Quality Index (PSQI) between two time points | To assess sleep quality. Higher scores are related to a worse sleep quality. | Month 3, Month 6 | |
| Primary | Covid19 Yorkshire Rehabilitation Scale (C19-YRS) | Clinical interview (qualitative evaluation) for investigating perceived outcomes after the acute phase of the pathology. | Referred changes between 3, 6 and 12 months after the symtomps onset | |
| Primary | Changes on pain intensity assessed with a Numeric Rating Scale (NRS) between three time points | To estimate the amount of pain perceived through a numerical classification in which higher scores indicate greater pain intensity | Month 3, Month 6, Month 12 | |
| Primary | Changes in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score between three time points | To investigate neuropathic charateristics of pain. The global score goes from 0 to 24, over 12 points it is palusible the presence of neuropathic mechanism. | Month 3, Month 6, Month 12 | |
| Primary | Changes in Central Sensitization Inventory (CSI) score between three time points | To detect the presence of central sensitization (score between 0-100 in which higher scores suggest the presence of central sensitization) | Month 3, Month 6, Month 12 | |
| Primary | Pressure Pain Threshold (PPT) | Changes assessed with an algometer on upper trapezius and rectus femoris bilaterally | Month 3, Month 6, Month 12 | |
| Primary | Temporal Summation (TS) | Changes assessed with an algometer on upper trapezius and rectus femoris bilaterally | Month 3, Month 6, Month 12 | |
| Primary | Changes in Pain Catastrophizing Scale (PCS) score between three time points | To examine the pain experience felt | Month 3, Month 6, Month 12 | |
| Primary | Changes in Tampa Scale of Kinesiophobia (TSK) score between three time points | For detecting the pain consequences on movement and related beliefs | Month 3, Month 6, Month 12 |