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

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)

Study Overview

• Status: Recruiting
• Conditions: Coronavirus Infections; Quality of Life; Covid19; Respiratory Failure; ARDS; Dyspnea; Respiratory Rehabilitation; Sars-CoV-2; Interstitial Pneumonia
• Intervention / Treatment: Other: Telerehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela Peghetti; Phone Number: +393314028226; Email: angela.peghetti@aosp.bo.it

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • Recruiting
      • Angela Peghetti
      • Contact: Angela Peghetti, Nurse; Phone Number: 3314028226; Email: angela.peghetti@aosp.bo.it
      • Contact: Carolina Guerrieri, Nurse; Phone Number: +39 051 2141461; Email: carolina.guerrieri@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Group; telerehabilitation	Other: Telerehabilitation; 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.
ACTIVE_COMPARATOR: Control group; Standard treatment	Other: Telerehabilitation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of daily living activities	Barthel Index Dispnea (BID)	through study completion, an average of 1 year
Improvement of thoracic expansion and lung volumes	COACH (volume incentive used in respiratory rehabilitation)	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)	through study completion, an average of 1 year
Improvement of the quality of life	St. George's Respiratory Questionnaire (SGRQ)	through study completion, an average of 1 year
Improvement of dyspnea in the execution of life activities	Barthel Index Dispnea (BID)	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)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Study Director: Carolina Guerrieri, Director, AOSP Bologna

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2021
• Primary Completion (ANTICIPATED): June 12, 2022
• Study Completion (ANTICIPATED): June 12, 2023

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (ACTUAL): August 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Lung Diseases; Signs and Symptoms, Respiratory; COVID-19; Coronavirus Infections; Respiratory Insufficiency; Pneumonia; Lung Diseases, Interstitial; Dyspnea
• Other Study ID Numbers: ReF2002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol
   Information identifier: Benedetta Isani

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No