Clinical trial NCT04615390: Recovery Profiles in Patients With SARS-CoV-2 Outcomes Undergoing Rehabilitation
Official title: Recovery Profiles in Patients With COVID-19 Outcomes Undergoing Rehabilitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19_rehabilitation
Keywords: covid19
rehabilitation
mindfulness
functional recovery
psychological well-being
pain
post covid syndrome
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People infected with COVID-19 and healthy subjects matched for age and sex (pain assessment).

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.


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

Primary outcomes:
measure: Borg scale
timeFrame: At the beginning of early rehabilitation
measure: Heart rate
timeFrame: At the beginning of early rehabilitation
measure: Oxygen saturation
timeFrame: At the beginning of early rehabilitation
measure: 30 seconds sit-to-stand test
timeFrame: At the beginning of early rehabilitation
measure: Change in 1 minute sit-to-stand test between two time points
timeFrame: Month 3, Month 6
measure: Change in Short form health survey between three time points
timeFrame: At the beginning of early rehabilitation, Month 3, Month 6
measure: 2-minute walking test
timeFrame: At the beginning of early rehabilitation
measure: Change in 6-minute walking test between two time points
timeFrame: Month 3, Month 6
measure: Change in Functional Independence Measure Scale between two time points
timeFrame: At the beginning of early rehabilitation, Month 3
measure: Change in Montreal Cognitive Assessment (MoCA) between two time points
timeFrame: Month 3, Month 6
measure: Cognitive Reserve Index questionnaire
timeFrame: Month 3
measure: Change in Patient Health Questionnaire-9 (PHQ-9) between two time points
timeFrame: Month 3, Month 6
measure: Change in Beck Anxiety Inventory (BAI) between two time points
timeFrame: Month 3, Month 6
measure: Change in Connor-Davidson Resilience Scale between two time points
timeFrame: Month 3, Month 6
measure: Change in Impact of Event Scale - Revised between two time points
timeFrame: Month 3, Month 6
measure: Change in General Self Efficacy Scale between two time points
timeFrame: Month 3, Month 6
measure: Change in Pittsburgh Sleep Quality Index (PSQI) between two time points
timeFrame: Month 3, Month 6
measure: Covid19 Yorkshire Rehabilitation Scale (C19-YRS)
timeFrame: Referred changes between 3, 6 and 12 months after the symtomps onset
measure: Changes on pain intensity assessed with a Numeric Rating Scale (NRS) between three time points
timeFrame: Month 3, Month 6, Month 12
measure: Changes in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score between three time points
timeFrame: Month 3, Month 6, Month 12
measure: Changes in Central Sensitization Inventory (CSI) score between three time points
timeFrame: Month 3, Month 6, Month 12
measure: Pressure Pain Threshold (PPT)
timeFrame: Month 3, Month 6, Month 12
measure: Temporal Summation (TS)
timeFrame: Month 3, Month 6, Month 12
measure: Changes in Pain Catastrophizing Scale (PCS) score between three time points
timeFrame: Month 3, Month 6, Month 12
measure: Changes in Tampa Scale of Kinesiophobia (TSK) score between three time points
timeFrame: Month 3, Month 6, Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Department of Neuroscience and Rehabilitation, University Hospital of Ferrara
state: Emilia Romagna
Study officials:
References: