The Effectiveness of Respiratory Tele-rehabilitation After COVID-19 Pneumonia Related: a Randomized Controlled Trial
Primary Purpose
Respiratory Failure, Sars-CoV-2, Covid19
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Telerehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure
Eligibility Criteria
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- Asymptomatic or paucisymptomatic patient;
- Institutionalized person;
- Unstable angina;
- Recent IMA;
- Life expectancy <12 months for other comorbidities (eg advanced cancer).
Sites / Locations
- Angela PeghettiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control group
Arm Description
telerehabilitation
Standard treatment
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Improvement of daily living activities
Barthel Index Dispnea (BID)
Improvement of thoracic expansion and lung volumes
COACH (volume incentive used in respiratory rehabilitation)
Improvement of muscle strength and endurance
6 minute walking test (6MWT) One Minute Sit To Stand (1MSTS) Short Physical Peformance Battery (SPPB)
Improvement of the quality of life
St. George's Respiratory Questionnaire (SGRQ)
Improvement of dyspnea in the execution of life activities
Barthel Index Dispnea (BID)
Improvement of the functionality of the lower limbs
One Minute Sit To Stand (1MSTS) Short Physical Peformance Battery (SPPB)
Full Information
NCT ID
NCT05007457
First Posted
April 12, 2021
Last Updated
August 13, 2021
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT05007457
Brief Title
The Effectiveness of Respiratory Tele-rehabilitation After COVID-19 Pneumonia Related: a Randomized Controlled Trial
Official Title
The Effectiveness of Respiratory Tele-rehabilitation After COVID-19 Pneumonia Related: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 12, 2021 (Actual)
Primary Completion Date
June 12, 2022 (Anticipated)
Study Completion Date
June 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Sars-CoV-2, Covid19, ARDS, Interstitial Pneumonia, Respiratory Rehabilitation, Dyspnea, Quality of Life, Coronavirus Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Partecipants, care providers and investigators are blinded only at the time of enrollment, subsequently they will learn about the group in which the partecipants were placed
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
telerehabilitation
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard treatment
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Six Minute Walking Test (6MWT)
Description
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)
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Improvement of daily living activities
Description
Barthel Index Dispnea (BID)
Time Frame
through study completion, an average of 1 year
Title
Improvement of thoracic expansion and lung volumes
Description
COACH (volume incentive used in respiratory rehabilitation)
Time Frame
through study completion, an average of 1 year
Title
Improvement of muscle strength and endurance
Description
6 minute walking test (6MWT) One Minute Sit To Stand (1MSTS) Short Physical Peformance Battery (SPPB)
Time Frame
through study completion, an average of 1 year
Title
Improvement of the quality of life
Description
St. George's Respiratory Questionnaire (SGRQ)
Time Frame
through study completion, an average of 1 year
Title
Improvement of dyspnea in the execution of life activities
Description
Barthel Index Dispnea (BID)
Time Frame
through study completion, an average of 1 year
Title
Improvement of the functionality of the lower limbs
Description
One Minute Sit To Stand (1MSTS) Short Physical Peformance Battery (SPPB)
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
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.
Exclusion Criteria:
Asymptomatic or paucisymptomatic patient;
Institutionalized person;
Unstable angina;
Recent IMA;
Life expectancy <12 months for other comorbidities (eg advanced cancer).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Peghetti
Phone
+393314028226
Email
angela.peghetti@aosp.bo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina Guerrieri, Director
Organizational Affiliation
AOSP Bologna
Official's Role
Study Director
Facility Information:
Facility Name
Angela Peghetti
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Peghetti, Nurse
Phone
3314028226
Email
angela.peghetti@aosp.bo.it
First Name & Middle Initial & Last Name & Degree
Carolina Guerrieri, Nurse
Phone
+39 051 2141461
Email
carolina.guerrieri@aosp.bo.it
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36066373
Citation
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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://aosp.bo.it
Available IPD/Information Identifier
Benedetta Isani
Learn more about this trial
The Effectiveness of Respiratory Tele-rehabilitation After COVID-19 Pneumonia Related: a Randomized Controlled Trial
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