Covid19_rehabilitation
Conditions
Keywords
covid19, rehabilitation, mindfulness, functional recovery, psychological well-being, pain, post covid syndrome
Brief summary
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.
Interventions
BEHAVIORALEarly rehabilitation
The intervention is primarily focused on the recovery of mobility and functional autonomy. The treatment sessions are dependent on the patient's exercise tolerance.
BEHAVIORALSubacute rehabilitation
Comprehensive intensive rehabilitation in the hospital
BEHAVIORALMindfulness training
The home mindfulness training consists of 2 parts: 1) explanation and reflection of the Mindfulness practice 2) formal and informal practice.
BEHAVIORALPersonalized ambulatory training
Low-intensity walking exercises at home
Sponsors
University Hospital of Ferrara
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Borg scale | At the beginning of early rehabilitation | Rating perceived exertion on a 10-points scale in which higher values correspond to havier symptomps. |
| Heart rate | At the beginning of early rehabilitation | Heart rate in sitting and standing positions. |
| Oxygen saturation | At the beginning of early rehabilitation | Oxygen saturation in sitting and standing positions. |
| 30 seconds sit-to-stand test | At the beginning of early rehabilitation | To measure the strength of the lower limbs. |
| Change in 1 minute sit-to-stand test between two time points | Month 3, Month 6 | To measure the strength of the lower limbs. |
| Change in Short form health survey between three time points | At the beginning of early rehabilitation, Month 3, Month 6 | 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. |
| 2-minute walking test | At the beginning of early rehabilitation | For mobility assessment |
| Change in 6-minute walking test between two time points | Month 3, Month 6 | For mobility assessment |
| Change in Functional Independence Measure Scale between two time points | At the beginning of early rehabilitation, Month 3 | 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. |
| Change in Montreal Cognitive Assessment (MoCA) between two time points | Month 3, Month 6 | Cognitive screening test. Higher scores (0-30) are related to a better performance. |
| Cognitive Reserve Index questionnaire | Month 3 | 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. |
| Change in Patient Health Questionnaire-9 (PHQ-9) between two time points | Month 3, Month 6 | To identify the presence of depression and measure its severity. Score goes from 0 to 27 in which higer numbers represent worse clinical outcomes. |
| Change in Beck Anxiety Inventory (BAI) between two time points | Month 3, Month 6 | To measure the severity of anxiety. Higher scores (0-63) indicates more severe anxiety symptoms |
| Change in Connor-Davidson Resilience Scale between two time points | Month 3, Month 6 | To measure the resilience. Total score goes from 0 to 40, higher points mean greater resilience. |
| Change in Impact of Event Scale - Revised between two time points | Month 3, Month 6 | 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. |
| Change in General Self Efficacy Scale between two time points | Month 3, Month 6 | 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. |
| Change in Pittsburgh Sleep Quality Index (PSQI) between two time points | Month 3, Month 6 | To assess sleep quality. Higher scores are related to a worse sleep quality. |
| Covid19 Yorkshire Rehabilitation Scale (C19-YRS) | Referred changes between 3, 6 and 12 months after the symtomps onset | Clinical interview (qualitative evaluation) for investigating perceived outcomes after the acute phase of the pathology. |
| Changes on pain intensity assessed with a Numeric Rating Scale (NRS) between three time points | Month 3, Month 6, Month 12 | To estimate the amount of pain perceived through a numerical classification in which higher scores indicate greater pain intensity |
| Changes in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score between three time points | Month 3, Month 6, Month 12 | 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. |
| Changes in Central Sensitization Inventory (CSI) score between three time points | Month 3, Month 6, Month 12 | To detect the presence of central sensitization (score between 0-100 in which higher scores suggest the presence of central sensitization) |
| Pressure Pain Threshold (PPT) | Month 3, Month 6, Month 12 | Changes assessed with an algometer on upper trapezius and rectus femoris bilaterally |
| Temporal Summation (TS) | Month 3, Month 6, Month 12 | Changes assessed with an algometer on upper trapezius and rectus femoris bilaterally |
| Changes in Pain Catastrophizing Scale (PCS) score between three time points | Month 3, Month 6, Month 12 | To examine the pain experience felt |
| Changes in Tampa Scale of Kinesiophobia (TSK) score between three time points | Month 3, Month 6, Month 12 | For detecting the pain consequences on movement and related beliefs |
Countries
Italy
Contacts
Primary ContactSofia Straudi, MD, PhD
Outcome results
None listed