Clinical Trials/NCT04615390

NCT04615390

Recruiting

Not Applicable

Recovery Profiles in Patients With COVID-19 Outcomes Undergoing Rehabilitation

University Hospital of Ferrara1 site in 1 country200 target enrollmentMarch 30, 2020

ConditionsCovid19_rehabilitation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Covid19_rehabilitation
Sponsor: University Hospital of Ferrara
Enrollment: 200
Locations: 1
Primary Endpoint: Borg scale
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 30, 2020

End Date

November 30, 2023

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital of Ferrara

Responsible Party

Principal Investigator

Sofia Straudi

MD, PhD

University Hospital of Ferrara

Eligibility Criteria

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

Time Frame: At the beginning of early rehabilitation

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

Heart rate

Time Frame: At the beginning of early rehabilitation

Heart rate in sitting and standing positions.

Oxygen saturation

Time Frame: At the beginning of early rehabilitation

Oxygen saturation in sitting and standing positions.

30 seconds sit-to-stand test

Time Frame: 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

Time Frame: Month 3, Month 6

To measure the strength of the lower limbs.

Change in Short form health survey between three time points

Time Frame: 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

Time Frame: At the beginning of early rehabilitation

For mobility assessment

Change in 6-minute walking test between two time points

Time Frame: Month 3, Month 6

For mobility assessment

Change in Functional Independence Measure Scale between two time points

Time Frame: 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

Time Frame: Month 3, Month 6

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

Cognitive Reserve Index questionnaire

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Month 3, Month 6

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

Covid19 Yorkshire Rehabilitation Scale (C19-YRS)

Time Frame: 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