Covid19_rehabilitationNCT04615390
Recovery Profiles in Patients With SARS-CoV-2 Outcomes Undergoing Rehabilitation
An observational study of Covid19_rehabilitation, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19_rehabilitation
- What is being tested?
- Early rehabilitation, Subacute rehabilitation and Mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 30 Mar 2020to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People infected with COVID-19 and healthy subjects matched for age and sex (pain assessment).
Who may be able to join
- diagnosis of covid19 (WHO criteria);
- indication for respiratory and / or neuromotor rehabilitation treatment
Who cannot join
- cognitive or communication impairment precluding informed consent
- severe medical conditions
- pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Neuroscience and Rehabilitation, University Hospital of Ferrara
Ferrara, Emilia-Romagna, 44124
Sofia Straudi, MD, PhD, 0532236185, s.straudi@ospfe.it
Sofia Straudi, MD, PhD
About this study
Official title: 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.
- Conditions
- Covid19_rehabilitation
- Being tested
- Early rehabilitation, Subacute rehabilitation, Mindfulness training, Personalized ambulatory training
- Keywords
- covid19, rehabilitation, mindfulness, functional recovery, psychological well-being, pain, post covid syndrome
- Medical subject headings
- COVID-19, Psychological Well-Being, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early rehabilitationBehavioural
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 rehabilitationBehavioural
Comprehensive intensive rehabilitation in the hospital
Mindfulness trainingBehavioural
The home mindfulness training consists of 2 parts: 1) explanation and reflection of the Mindfulness practice 2) formal and informal practice.
Personalized ambulatory trainingBehavioural
Low-intensity walking exercises at home
What is being measured
The primary outcome is the main question the study is designed to answer.
Borg scale
Rating perceived exertion on a 10-points scale in which higher values correspond to havier symptomps.
Measured: At the beginning of early rehabilitation
Heart rate
Heart rate in sitting and standing positions.
Measured: At the beginning of early rehabilitation
Oxygen saturation
Oxygen saturation in sitting and standing positions.
Measured: At the beginning of early rehabilitation
30 seconds sit-to-stand test
To measure the strength of the lower limbs.
Measured: 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.
Measured: 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.
Measured: At the beginning of early rehabilitation, Month 3, Month 6
2-minute walking test
For mobility assessment
Measured: At the beginning of early rehabilitation
Change in 6-minute walking test between two time points
For mobility assessment
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: Month 3, Month 6, Month 12
Pressure Pain Threshold (PPT)
Changes assessed with an algometer on upper trapezius and rectus femoris bilaterally
Measured: Month 3, Month 6, Month 12
Temporal Summation (TS)
Changes assessed with an algometer on upper trapezius and rectus femoris bilaterally
Measured: Month 3, Month 6, Month 12
Changes in Pain Catastrophizing Scale (PCS) score between three time points
To examine the pain experience felt
Measured: 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
Measured: Month 3, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start30 Mar 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19_rehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Straudi, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615390
- Sponsor's protocol ID
- Covid-19_rehabilitation
- Status last verified
- Jan 2023
- First submitted
- 29 Oct 2020
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Profiles in Patients With COVID-19 Outcomes Undergoing Rehabilitation
- ClinicalTrials.gov ID
- NCT04615390
- Acronym / sponsor ID
- Covid-19_rehabilitation
- Conditions
- Covid19_rehabilitation
- Keywords
- covid19, rehabilitation, mindfulness, functional recovery, psychological well-being, pain, post covid syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People infected with COVID-19 and healthy subjects matched for age and sex (pain assessment).
Key inclusion criteria (2 listed)
- diagnosis of covid19 (WHO criteria);
- indication for respiratory and / or neuromotor rehabilitation treatment
Key exclusion criteria (3 listed)
- cognitive or communication impairment precluding informed consent
- severe medical conditions
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early rehabilitationThe intervention is primarily focused on the recovery of mobility and functional autonomy. The treatment sessions are dependent on the patient's exercise tolerance. | Behavioural | – |
| Subacute rehabilitationComprehensive intensive rehabilitation in the hospital | Behavioural | – |
| Mindfulness trainingThe home mindfulness training consists of 2 parts: 1) explanation and reflection of the Mindfulness practice 2) formal and informal practice. | Behavioural | – |
| Personalized ambulatory trainingLow-intensity walking exercises at home | Behavioural | – |
Primary outcome
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.
Heart rate
Time frame: At the beginning of early rehabilitation
Heart rate in sitting and standing positions.
Oxygen saturation
Time frame: At the beginning of early rehabilitation
Oxygen saturation in sitting and standing positions.
30 seconds sit-to-stand test
Time frame: At the beginning of early rehabilitation
To measure the strength of the lower limbs.
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.
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.
2-minute walking test
Time frame: At the beginning of early rehabilitation
For mobility assessment
Change in 6-minute walking test between two time points
Time frame: Month 3, Month 6
For mobility assessment
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.
Change in Montreal Cognitive Assessment (MoCA) between two time points
Time frame: Month 3, Month 6
Cognitive screening test. Higher scores (0-30) are related to a better performance.
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.
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.
Change in Beck Anxiety Inventory (BAI) between two time points
Time frame: Month 3, Month 6
To measure the severity of anxiety. Higher scores (0-63) indicates more severe anxiety symptoms
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.
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.
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.
Change in Pittsburgh Sleep Quality Index (PSQI) between two time points
Time frame: Month 3, Month 6
To assess sleep quality. Higher scores are related to a worse sleep quality.
Covid19 Yorkshire Rehabilitation Scale (C19-YRS)
Time frame: Referred changes between 3, 6 and 12 months after the symtomps onset
Clinical interview (qualitative evaluation) for investigating perceived outcomes after the acute phase of the pathology.
Changes on pain intensity assessed with a Numeric Rating Scale (NRS) between three time points
Time frame: Month 3, Month 6, Month 12
To estimate the amount of pain perceived through a numerical classification in which higher scores indicate greater pain intensity
Changes in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score between three time points
Time frame: Month 3, Month 6, Month 12
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.
Changes in Central Sensitization Inventory (CSI) score between three time points
Time frame: Month 3, Month 6, Month 12
To detect the presence of central sensitization (score between 0-100 in which higher scores suggest the presence of central sensitization)
Pressure Pain Threshold (PPT)
Time frame: Month 3, Month 6, Month 12
Changes assessed with an algometer on upper trapezius and rectus femoris bilaterally
Temporal Summation (TS)
Time frame: Month 3, Month 6, Month 12
Changes assessed with an algometer on upper trapezius and rectus femoris bilaterally
Changes in Pain Catastrophizing Scale (PCS) score between three time points
Time frame: Month 3, Month 6, Month 12
To examine the pain experience felt
Changes in Tampa Scale of Kinesiophobia (TSK) score between three time points
Time frame: Month 3, Month 6, Month 12
For detecting the pain consequences on movement and related beliefs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19_rehabilitation, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sofia Straudi, MD, PhD (0532238720, s.straudi@ospfe.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Borg scale (time frame: At the beginning of early rehabilitation). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.