Clinical trial NCT05007457: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Sars-CoV-2
Covid19
ARDS
Interstitial Pneumonia
Respiratory Rehabilitation
Dyspnea
Quality of Life
Coronavirus Infections
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Six Minute Walking Test (6MWT)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Improvement of daily living activities
timeFrame: through study completion, an average of 1 year
measure: Improvement of thoracic expansion and lung volumes
timeFrame: through study completion, an average of 1 year
measure: Improvement of muscle strength and endurance
timeFrame: through study completion, an average of 1 year
measure: Improvement of the quality of life
timeFrame: through study completion, an average of 1 year
measure: Improvement of dyspnea in the execution of life activities
timeFrame: through study completion, an average of 1 year
measure: Improvement of the functionality of the lower limbs
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Angela Peghetti
state: BO
Study officials:
affiliation: AOSP Bologna
name: Carolina Guerrieri, Director
role: STUDY_DIRECTOR
References:
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.