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

NCT04615390 | Unknown DMC

• 1 other identifier: Covid-19_rehabilitation
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19_rehabilitation

Keywords

covid19; rehabilitation; mindfulness; functional recovery; psychological well-being; pain; post covid syndrome

Outcome Measures

Primary Outcomes (25)

• 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

Interventions

Early rehabilitation BEHAVIORAL

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

Subacute rehabilitation BEHAVIORAL

Comprehensive intensive rehabilitation in the hospital

Mindfulness training BEHAVIORAL

The home mindfulness training consists of 2 parts: 1) explanation and reflection of the Mindfulness practice 2) formal and informal practice.

Personalized ambulatory training BEHAVIORAL

Low-intensity walking exercises at home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• diagnosis of covid19 (WHO criteria);
• indication for respiratory and / or neuromotor rehabilitation treatment

You may not qualify if:

• cognitive or communication impairment precluding informed consent
• severe medical conditions
• pregnancy

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Department of Neuroscience and Rehabilitation, University Hospital of Ferrara

Ferrara, Emilia-Romagna, 44124, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19; Psychological Well-Being; Pain

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Personal Satisfaction; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sofia Straudi, MD, PhD

CONTACT

0532238720; s.straudi@ospfe.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 4, 2020
• Study Start: March 30, 2020
• Primary Completion: June 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

IT (1)