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

• ClinicalTrials.gov Identifier: NCT04615390
• Recruitment Status: Recruiting
• First Posted: November 4, 2020
• Last Update Posted: September 5, 2021
• Sponsor: University Hospital of Ferrara
• Information provided by (Responsible Party): Sofia Straudi, University Hospital of Ferrara

Study Description

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 during the hospital rehabilitation period and after 6, 12 and 26 weeks.

Condition or disease	Intervention/treatment
Covid19_rehabilitation	Behavioral: Early rehabilitation; Behavioral: Subacute rehabilitation; Behavioral: Mindfulness training; Behavioral: Personalized ambulatory training

Study Design

• Study Type: Observational
• Estimated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Recovery Profiles in Patients With COVID-19 Outcomes Undergoing Rehabilitation
• Actual Study Start Date: March 30, 2020
• Estimated Primary Completion Date: December 1, 2021
• Estimated Study Completion Date: December 1, 2021

Groups and Cohorts

Intervention Details:

• Behavioral: Early rehabilitation
  The intervention is primarily focused on the recovery of mobility and functional autonomy. The treatment sessions are dependent on the patient's exercise tolerance.
• Behavioral: Subacute rehabilitation
  Comprehensive intensive rehabilitation in the hospital
• Behavioral: Mindfulness training
  The home mindfulness training consists of 2 parts: 1) explanation and reflection of the Mindfulness practice 2) formal and informal practice.
• Behavioral: Personalized ambulatory training
  Low-intensity walking exercises at home

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Heart rate [ Time Frame: At the beginning of early rehabilitation ]
   Heart rate in sitting and standing positions.
3. Oxygen saturation [ Time Frame: At the beginning of early rehabilitation ]
   Oxygen saturation in sitting and standing positions.
4. 30 seconds sit-to-stand test [ Time Frame: At the beginning of early rehabilitation ]
   To measure the strength of the lower limbs.
5. 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.
6. 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.
7. 2-minute walking test [ Time Frame: At the beginning of early rehabilitation ]
   For mobility assessment
8. Change in 6-minute walking test between two time points [ Time Frame: Month 3, Month 6 ]
   For mobility assessment
9. 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.
10. Change in Montreal Cognitive Assessment between two time points [ Time Frame: Month 3, Month 6 ]
    Cognitive screening test
11. 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.
12. 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.
13. Change in Beck anxiety inventory between two time points [ Time Frame: Month 3, Month 6 ]
    To measure the severity of anxiety
14. 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.
15. 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.
16. 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.
17. Change in Pittsburgh Sleep Quality Index between two time points [ Time Frame: Month 3, Month 6 ]
    To assess sleep quality
18. Covid19 Yorkshire Rehabilitation Scale (C19-YRS) [ Time Frame: Referred changes between 3 and 6 months after the symtomps onset ]
    Clinical interview (qualitative evaluation) for investigating perceived outcomes after the acute phase of the pathology.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

People infected with the COVID-19 virus

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

Contacts and Locations

Contacts

Contact: Sofia Straudi, MD, PhD; 0532238720; s.straudi@ospfe.it

Locations

Italy

Department of Neuroscience and Rehabilitation, University Hospital of Ferrara; Recruiting

Ferrara, Emilia Romagna, Italy, 44124

Contact: Sofia Straudi, MD, PhD 0532236185 s.straudi@ospfe.it

Principal Investigator: Sofia Straudi, MD, 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: Nicola Lamberti, PhD

Sub-Investigator: Anna Scotti, MD

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

Sponsors and Collaborators

University Hospital of Ferrara

More Information

• Responsible Party: Sofia Straudi, MD, PhD, University Hospital of Ferrara
• ClinicalTrials.gov Identifier: NCT04615390
• Other Study ID Numbers: Covid-19_rehabilitation
• First Posted: November 4, 2020
• Last Update Posted: September 5, 2021
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sofia Straudi, University Hospital of Ferrara:

covid19; rehabilitation; mindfulness; functional recovery; psychological well-being

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases