Recovery Profiles in Patients With SARS-CoV-2 Outcomes Undergoing Rehabilitation

University Hospital of Ferrara200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Covid19_rehabilitation

Interventions

Early rehabilitationBEHAVIORAL

The intervention is primarily focused on the recovery of mobility and functional autonomy. The treatment sessions are dependent on the patient's exercise tolerance.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Borg scale

Rating perceived exertion on a 10-points scale in which higher values correspond to havier symptomps.

Time frame: At the beginning of early rehabilitation

Heart rate

Heart rate in sitting and standing positions.

Time frame: At the beginning of early rehabilitation

Oxygen saturation

Oxygen saturation in sitting and standing positions.

Time frame: At the beginning of early rehabilitation

30 seconds sit-to-stand test

To measure the strength of the lower limbs.

Time frame: At the beginning of early rehabilitation

Change in 1 minute sit-to-stand test between two time points

To measure the strength of the lower limbs.

Time frame: Month 3, Month 6

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.

Time frame: At the beginning of early rehabilitation, Month 3, Month 6

2-minute walking test

For mobility assessment

Time frame: At the beginning of early rehabilitation

Change in 6-minute walking test between two time points

For mobility assessment

Time frame: Month 3, Month 6

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.

Time frame: At the beginning of early rehabilitation, Month 3

Change in Montreal Cognitive Assessment (MoCA) between two time points

Cognitive screening test. Higher scores (0-30) are related to a better performance.

Time frame: Month 3, Month 6

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.

Time frame: Month 3

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.

Time frame: Month 3, Month 6

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

Time frame: Month 3, Month 6

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.

Time frame: Month 3, Month 6

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.

Time frame: Month 3, Month 6

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.

Time frame: Month 3, Month 6

Change in Pittsburgh Sleep Quality Index (PSQI) between two time points

To assess sleep quality. Higher scores are related to a worse sleep quality.

Time frame: Month 3, Month 6

Covid19 Yorkshire Rehabilitation Scale (C19-YRS)

Clinical interview (qualitative evaluation) for investigating perceived outcomes after the acute phase of the pathology.

Time frame: Referred changes between 3, 6 and 12 months after the symtomps onset

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