NCT05007457

The Effectiveness of Respiratory Tele-rehabilitation After COVID-19 Pneumonia Related: a Randomized Controlled Trial

Status unknown NA Last updated 16 August 2021

What this trial tests

NA trial testing Telerehabilitation in Respiratory Failure in 100 participants. Status unknown.

Timeline

12 June 2021

Primary endpoint
12 June 2022

12 June 2023

Quick facts

Lead sponsor	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	12 June 2021
Primary completion	12 June 2022
Estimated completion	12 June 2023
Sites	1 location across Italy

Drugs / interventions tested

• Telerehabilitation

Conditions studied

• Respiratory Failure — all drugs for Respiratory Failure →
• Sars-CoV-2 — all drugs for Sars-CoV-2 →
• Covid19 — all drugs for Covid19 →
• ARDS — all drugs for ARDS →

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna — full company profile →

Who can join

18 and older, any sex, with Respiratory Failure or Sars-CoV-2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Chest physiotherapy for pneumonia in adults.
   Chen X, Jiang J, Wang R, Fu H, et al · · 2022 · cited 10× · PMID 36066373 · DOI 10.1002/14651858.cd006338.pub4