Respiratory FailureNCT05007457
The Effectiveness of Respiratory Tele-rehabilitation After COVID-19 Pneumonia Related: a Randomized Controlled Trial
A study testing Telerehabilitation in people with Respiratory Failure and Sars-CoV-2, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
In recent months, more and more studies suggest tele-rehabilitation as a means to be exploited to reduce the risk of contagion. The intent of our study is to verify the effectiveness of a tele-rehabilitation intervention through the application of a respiratory rehabilitation program supported by contact with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Sars-CoV-2, Covid19
- What is being tested?
- Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jun 2021to 12 Jun 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COVID19;
- Respiratory failure in Sars-Cov2 pneumonia;
- ARDS in Sars-Cov2 pneumonia;
- Interstitial pneumonia from Sars-Cov2;
- Rankin scale ≥ 3/5 before enrollment (therefore at discharge);
- Patients in need of rehabilitation;
Show all 10Show fewer
- Patients discharged from the hospital at their home;
- Patients with internet access;
- Owners and users of smartphones / tablets / PCs;
- Owners a pedal / stationary bike and oximeter.
Who cannot join
- Asymptomatic or paucisymptomatic patient;
- Institutionalized person;
- Unstable angina;
- Recent IMA;
- Life expectancy <12 months for other comorbidities (eg advanced cancer).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Angela Peghetti
Bologna, BO, 40138
Angela Peghetti, Nurse, 3314028226, angela.peghetti@aosp.bo.it
Carolina Guerrieri, Nurse, +39 051 2141461, carolina.guerrieri@aosp.bo.it
About this study
In recent months, more and more studies suggest tele-rehabilitation as a means to be exploited to reduce the risk of contagion.
The intent of our study is to verify the effectiveness of a tele-rehabilitation intervention through the application of a respiratory rehabilitation program supported by contact with physiotherapists, in patients with outcomes from SARS-CoV-2 infection discharged from the various medical departments and taken over by physiotherapists after physiatric evaluation.
Read more
Faced with the same rehabilitation program prescribed to all patients, the primary objective of our study is to detect whether patients supported by remote rehabilitation after hospitalization improve both adherence to the rehabilitation program and cardiorespiratory endurance and dyspnea symptoms assessed with the Six Minute Walking Test scale (6MWT). This test is validated for multiple pathologies, including idiopathic pulmonary fibrosis, the clinic of which could be comparable to the outcomes of coronavirus interstitial pneumonia as suggested by the literature.
The secondary objectives concern the assessment of the impact of physical exercise assisted by tele-rehabilitation detected through: the assessment of the quality of life (Saint George Respiratory Questionnaire );the assessment of autonomy in daily life activities (Barthel Index Dyspnea Scale), the evaluation of the variation in thoracic expansion and lung volumes (with COACH , an instrument for respiratory physiotherapy that measures the inspiratory volume in ml); the evaluation of muscle strength and endurance (One Minute Sit To Stand) ; the detection of dyspnea during the execution of the exercises (Modified Borg scale); the assessment of the functionality of the lower limbs (Short Physical Performance Battery)
Read the detailed description
With regard to respiratory problems, there are still no precise data on the long-term consequences of pulmonary fibrosis and therefore related to the insufficient functioning of the lung. It is possible to hypothesize that these deficiencies can be treated with one specific respiratory rehabilitation aimed at reducing dyspnea and difficulty in practicing daily activities and moving around. In fact, the scientific literature indicates that respiratory rehabilitation improves the quality of life and exercise tolerance of patients with IPF (idiopathic Pulmonary Fibrosis), by reducing respiratory deficits, hypotrophy and muscle weakness, physical deconditioning. Respiratory rehabilitation means a "multidisciplinary intervention based on scientific evidence for patients with chronic respiratory disorders who are symptomatic and often have a reduced quality of life, in need of aerobic and respiratory muscle training, but also oxygen, nutritional, educational, psychological support as well as therapeutic education. For all these reasons we have decided to start our blinded, single-center randomized controlled study, the details of which will be specified later.
- Conditions
- Respiratory Failure, Sars-CoV-2, Covid19, ARDS, Interstitial Pneumonia, Respiratory Rehabilitation
- Being tested
- Telerehabilitation
- Medical subject headings
- Respiratory Insufficiency, COVID-19, Lung Diseases, Interstitial, Dyspnea, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
Patients belonging to the experimental group will receive the brochure and, weekly a telematic comparison will take place lasting about 30 minutes, with a physiotherapist to be asked questions. The physiotherapist will be able to evaluate and modify the training program based on the patient's response.
The tele-rehabilitation sessions will take place: once / week for the first month, once every 2 weeks for the second month and from the third month from the third month the patient can contact the professionals in case of doubts or questions regarding the exercises he is taking place at home.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | telerehabilitation Receives: Other: Telerehabilitation |
| Control group | Active comparator | Standard treatment Receives: Other: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Minute Walking Test (6MWT)
Six Minute Walking Test (6MWT) variation of more than 21.7 meters after 10 weeks of rehabilitation (the least clinically significant variation in patients with IPF - idiopathic pulmonary fibrosis - for the 6MWT is more than 21.7 meters after 6 months of rehabilitation)
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Improvement of daily living activities
Barthel Index Dispnea (BID)
Measured: through study completion, an average of 1 year
Improvement of thoracic expansion and lung volumes
COACH (volume incentive used in respiratory rehabilitation)
Measured: through study completion, an average of 1 year
Improvement of muscle strength and endurance
6 minute walking test (6MWT) One Minute Sit To Stand (1MSTS) Short Physical Peformance Battery (SPPB)
Measured: through study completion, an average of 1 year
Improvement of the quality of life
St. George's Respiratory Questionnaire (SGRQ)
Measured: through study completion, an average of 1 year
Improvement of dyspnea in the execution of life activities
Barthel Index Dispnea (BID)
Measured: through study completion, an average of 1 year
Improvement of the functionality of the lower limbs
One Minute Sit To Stand (1MSTS) Short Physical Peformance Battery (SPPB)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start12 Jun 2021
- Primary completion12 Jun 2022 (estimated)
- Study completion12 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Peghetti, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Carolina Guerrieri, Director, Study director, AOSP Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007457
- Sponsor's protocol ID
- ReF2002
- Status last verified
- Aug 2021
- First submitted
- 12 Apr 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen X, Jiang J, Wang R, Fu H, Lu J, Yang M. Chest physiotherapy for pneumonia in adults. Cochrane Database Syst Rev. 2022 Sep 6;9(9):CD006338. doi: 10.1002/14651858.CD006338.pub4.
PubMed 36066373
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Respiratory Tele-rehabilitation After COVID-19 Pneumonia Related: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05007457
- Acronym / sponsor ID
- ReF2002
- Conditions
- Respiratory Failure, Sars-CoV-2, Covid19, ARDS, Interstitial Pneumonia, Respiratory Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 12 Jun 2021 (actual)
- Primary completion
- 12 Jun 2022 (estimated)
- Study completion
- 12 Jun 2023 (estimated)
- First posted
- 16 Aug 2021 (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.
In recent months, more and more studies suggest tele-rehabilitation as a means to be exploited to reduce the risk of contagion.
The intent of our study is to verify the effectiveness of a tele-rehabilitation intervention through the application of a respiratory rehabilitation program supported by contact with physiotherapists, in patients with outcomes from SARS-CoV-2 infection discharged from the various medical departments and taken over by physiotherapists after physiatric evaluation.
Faced with the same rehabilitation program prescribed to all patients, the primary objective of our study is to detect whether patients supported by remote rehabilitation after hospitalization improve both adherence to the rehabilitation program and cardiorespiratory endurance and dyspnea symptoms assessed with the Six Minute Walking Test scale (6MWT). This test is validated for multiple pathologies, including idiopathic pulmonary fibrosis, the clinic of which could be comparable to the outcomes of coronavirus interstitial pneumonia as suggested by the literature.
The secondary objectives concern the assessment of the impact of physical exercise assisted by tele-rehabilitation detected through: the assessment of the quality of life (Saint George Respiratory Questionnaire );the assessment of autonomy in daily life activities (Barthel Index Dyspnea Scale), the evaluation of the variation in thoracic expansion and lung volumes (with COACH , an instrument for respiratory physiotherapy that measures the inspiratory volume in ml); the evaluation of muscle strength and endurance (One Minute Sit To Stand) ; the detection of dyspnea during the execution of the exercises (Modified Borg scale); the assessment of the functionality of the lower limbs (Short Physical Performance Battery)
Detailed description
With regard to respiratory problems, there are still no precise data on the long-term consequences of pulmonary fibrosis and therefore related to the insufficient functioning of the lung. It is possible to hypothesize that these deficiencies can be treated with one specific respiratory rehabilitation aimed at reducing dyspnea and difficulty in practicing daily activities and moving around. In fact, the scientific literature indicates that respiratory rehabilitation improves the quality of life and exercise tolerance of patients with IPF (idiopathic Pulmonary Fibrosis), by reducing respiratory deficits, hypotrophy and muscle weakness, physical deconditioning. Respiratory rehabilitation means a "multidisciplinary intervention based on scientific evidence for patients with chronic respiratory disorders who are symptomatic and often have a reduced quality of life, in need of aerobic and respiratory muscle training, but also oxygen, nutritional, educational, psychological support as well as therapeutic education. For all these reasons we have decided to start our blinded, single-center randomized controlled study, the details of which will be specified later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Telerehabilitationtelerehabilitation |
| Control group | Active comparator | Other: TelerehabilitationStandard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of COVID19;
- Respiratory failure in Sars-Cov2 pneumonia;
- ARDS in Sars-Cov2 pneumonia;
- Interstitial pneumonia from Sars-Cov2;
- Rankin scale ≥ 3/5 before enrollment (therefore at discharge);
Key exclusion criteria (5 listed)
- Asymptomatic or paucisymptomatic patient;
- Institutionalized person;
- Unstable angina;
- Recent IMA;
- Life expectancy <12 months for other comorbidities (eg advanced cancer).
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 |
|---|---|---|
| TelerehabilitationPatients belonging to the experimental group will receive the brochure and, weekly a telematic comparison will take place lasting about 30 minutes, with a physiotherapist to be asked questions. The physiotherapist will be able to evaluate and modify the training program based on the patient's response. The tele-rehabilitation sessions will take place: once / week for the first month, once every 2 weeks for the second month and from the third month from the third month the patient can contact the professionals in case of doubts or questions regarding the exercises he is taking place at home. | Other | Control group, Experimental Group |
Primary outcome
Six Minute Walking Test (6MWT)
Time frame: through study completion, an average of 1 year
Six Minute Walking Test (6MWT) variation of more than 21.7 meters after 10 weeks of rehabilitation (the least clinically significant variation in patients with IPF - idiopathic pulmonary fibrosis - for the 6MWT is more than 21.7 meters after 6 months of rehabilitation)
6 secondary outcomes
Improvement of daily living activities
Time frame: through study completion, an average of 1 year
Improvement of thoracic expansion and lung volumes
Time frame: through study completion, an average of 1 year
Improvement of muscle strength and endurance
Time frame: through study completion, an average of 1 year
Improvement of the quality of life
Time frame: through study completion, an average of 1 year
Improvement of dyspnea in the execution of life activities
Time frame: through study completion, an average of 1 year
Improvement of the functionality of the lower limbs
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Derived from this study: PubMed 36066373Chen X, Jiang J, Wang R, Fu H, Lu J, Yang M. Chest physiotherapy for pneumonia in adults. Cochrane Database Syst Rev. 2022 Sep 6;9(9):CD006338. doi: 10.1002/14651858.CD006338.pub4.
- Individual participant dataSharing planned: No
Related trials for Respiratory Failure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
Carolina Guerrieri, Director study director
AOSP Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Respiratory Failure and Sars-CoV-2, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 10 inclusion and 5 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 16 Aug 2021. 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 Angela Peghetti (+393314028226, angela.peghetti@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six Minute Walking Test (6MWT) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05007457, which also lists 1 linked publication.
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 16 Aug 2021.