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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19_rehabilitation
• Intervention / Treatment: Behavioral: Early rehabilitation; Behavioral: Subacute rehabilitation; Behavioral: Mindfulness training; Behavioral: Personalized ambulatory training

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Sofia Straudi, MD, PhD; Phone Number: 0532238720; Email: s.straudi@ospfe.it

Study Locations

• Italy
  • Emilia Romagna
    • Ferrara, Emilia Romagna, Italy, 44124
      • Recruiting
      • Department of Neuroscience and Rehabilitation, University Hospital of Ferrara
      • Contact: Sofia Straudi, MD, PhD; Phone Number: 0532236185; Email: s.straudi@ospfe.it
      • Principal Investigator: Sofia Straudi, MD, PhD
      • Sub-Investigator: Anna Scotti, MD
      • Sub-Investigator: Nicola Lamberti, PhD
      • Sub-Investigator: Francesco Baldasso, MD
      • Sub-Investigator: Antonella Occhi, PT
      • Sub-Investigator: Silvia Mottaran, PT
      • Sub-Investigator: Ilaria Ferioli, PT
      • Sub-Investigator: Fabio Manfredini, MD, PhD
      • Sub-Investigator: Giada Milani, PsyD, PhD student
      • Sub-Investigator: Giulia Dallagà, PsyD
      • Sub-Investigator: Susanna Lavezzi, MD
      • Sub-Investigator: Francesca Filippini, PT
      • Sub-Investigator: Giulia Bellon, MD
      • Sub-Investigator: Alessandra Botti, MD
      • Sub-Investigator: Elisabetta Antiga, MD
      • Sub-Investigator: Dino De Filippo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

People infected with COVID-19 and healthy subjects matched for age and sex (pain assessment).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Borg scale	Rating perceived exertion on a 10-points scale in which higher values correspond to havier symptomps.	At the beginning of early rehabilitation
Heart rate	Heart rate in sitting and standing positions.	At the beginning of early rehabilitation
Oxygen saturation	Oxygen saturation in sitting and standing positions.	At the beginning of early rehabilitation
30 seconds sit-to-stand test	To measure the strength of the lower limbs.	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.	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.	At the beginning of early rehabilitation, Month 3, Month 6
2-minute walking test	For mobility assessment	At the beginning of early rehabilitation
Change in 6-minute walking test between two time points	For mobility assessment	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.	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.	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.	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.	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	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.	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.	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.	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.	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.	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	Month 3, Month 6, Month 12
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
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
Pressure Pain Threshold (PPT)	Changes assessed with an algometer on upper trapezius and rectus femoris bilaterally	Month 3, Month 6, Month 12
Temporal Summation (TS)	Changes assessed with an algometer on upper trapezius and rectus femoris bilaterally	Month 3, Month 6, Month 12
Changes in Pain Catastrophizing Scale (PCS) score between three time points	To examine the pain experience felt	Month 3, Month 6, Month 12
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

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2020
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: pain; rehabilitation; mindfulness; covid19; psychological well-being; functional recovery; post covid syndrome
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Covid-19_rehabilitation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No