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

Sponsor
University Hospital of Ferrara (Other)
Overall Status
Recruiting
CT.gov ID
NCT04615390
Collaborator
(none)
200
1
37
5.4

Study Details

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 Phase
  • Behavioral: Early rehabilitation
  • Behavioral: Subacute rehabilitation
  • Behavioral: Mindfulness training
  • Behavioral: Personalized ambulatory training

Study Design

Study Type:
Observational
Anticipated 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 :
Mar 30, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Borg scale [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 [At the beginning of early rehabilitation]

    Heart rate in sitting and standing positions.

  3. Oxygen saturation [At the beginning of early rehabilitation]

    Oxygen saturation in sitting and standing positions.

  4. 30 seconds sit-to-stand test [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 [Month 3, Month 6]

    To measure the strength of the lower limbs.

  6. Change in Short form health survey between three time points [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 [At the beginning of early rehabilitation]

    For mobility assessment

  8. Change in 6-minute walking test between two time points [Month 3, Month 6]

    For mobility assessment

  9. Change in Functional Independence Measure Scale between two time points [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 [Month 3, Month 6]

    Cognitive screening test

  11. Cognitive Reserve Index questionnaire [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 [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 [Month 3, Month 6]

    To measure the severity of anxiety

  14. Change in Connor-Davidson Resilience Scale between two time points [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 [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 [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 [Month 3, Month 6]

    To assess sleep quality

  18. Covid19 Yorkshire Rehabilitation Scale (C19-YRS) [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Department of Neuroscience and Rehabilitation, University Hospital of Ferrara Ferrara Emilia Romagna Italy 44124

Sponsors and Collaborators

  • University Hospital of Ferrara

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sofia Straudi, MD, PhD, University Hospital of Ferrara
ClinicalTrials.gov Identifier:
NCT04615390
Other Study ID Numbers:
  • Covid-19_rehabilitation
First Posted:
Nov 4, 2020
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sofia Straudi, MD, PhD, University Hospital of Ferrara
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2022