Digital App for Telerehabilitation in Respiratory Diseases

NCT05572346 | Unknown

• 1 other identifier: RE-TEL
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the feasibility and the mid-term effects of a pulmonary rehabilitation intervention, delivered by digital App, on quality of life of patients affected by respiratory diseases. The App will include a monitored exercise training program based on most recent cardiopulmonary rehabilitation guidelines, including alerts, reminders and educational contents as well as chat and online visits with healthcare professionals to improve patient engagement.

Conditions

Respiratory Disease; Asthma; Long COVID; Chronic Obstructive Pulmonary Disease; Obesity; Lung Fibrosis; Bronchiectasis

Keywords

Respiratory Diseases; Telerehabilitation; Digital tools

Outcome Measures

Primary Outcomes (1)

• Effects of home-based telerehabilitation intervention on self-perceived overall quality of life

  Rating of EuroQoL 5D-5L Visual Analogue Scale (VAS) score changes: the EuroQoL 5D-5LVAS scale is a graduated line ranging from 0 (worse quality of life) to 100 (better quality of life). Longitudinal changes will be obtained subtracting baseline VAS to VAS at follow-up. A positive score means quality of life improvement, a negative score, a worsening of quality of life.

  8 weeks

Secondary Outcomes (9)

• Effects of home-based telerehabilitation intervention on quality of life

  8 weeks

• Effects of home-based telerehabilitation intervention on exercise tolerance

  8 weeks

• Effects of home-based telerehabilitation intervention on heart rate

  8 weeks

• Effects of home-based telerehabilitation intervention on fatigue during exercise

  8 weeks

• Effects of home-based telerehabilitation intervention on dyspnea perception

  8 weeks

Study Arms (1)

Home-based telerehabilitation group

For each subject, the treatment will lasts 8 weeks. The intervention will include both endurance and resistance exercises as prescribed by the pneumologist at the time of the hospital discharge. The intervention will be delivered and monitored through a digital app with appropriate sensors.

Other: Home-based telerehabilitation program delivered through digital devices

Interventions

Home-based telerehabilitation program delivered through digital devices OTHER

To evaluate the effects of digital home-based telerehabilitation program on functional and spirometric measures as well as on quality of life in patients with chronic respiratory disease

Home-based telerehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients discharged from the Pulmonary Rehabilitation Unit of ICS Maugeri - IRCCS Lumezzane (Lumezzane - BS, Italia), affected by COPD, asthma, pulmonary fibrosis, bronchiectasis, obesity or long COVID syndrome.

You may qualify if:

• Diagnosis of COPD with Tiffenau index lower than 70%, FEV1 lower than 80%, asthma, bronchiectasis, pulmonary fibrosis, obesity (BMI higher than 30), long COVID syndrome;
• Mini-mental status examination higher than 22;
• Ability to perform a 6MWT with or without assistive devices;
• Patients discharged from the Pulmonary Rehabilitation Unit less than two weeks before the enrollment;
• Release of written informed consent

You may not qualify if:

• Simultaneous participation to other research projects;
• Simultaneous participation to other rehabilitation interventions;
• High risk of heart failure and/or ventricular dysfunction;
• High thrombotic risk;
• Cardiac surgery within 3 months after the study enrollment;
• High risk of arrhythmias;
• Atrial fibrillation
• Moderate to severe valvulopathy;
• Severe or not adequately controlled respiratory diseases;
• Hemodynamic instability;
• Anemia (Hb lower than 10 g/dl);
• Pregnancy;
• History of drugs abuse
• Total or partial inability to use digital devices
• Barriers to exercise training completion

Sponsors & Collaborators

• MedicAir Healthcare S.r.l.: lead

Study Sites (1)

ICS Maugeri - IRCCS Lumezzane

Lumezzane, Brescia, Italy

RECRUITING

MeSH Terms

Conditions

Respiration Disorders; Asthma; Post-Acute COVID-19 Syndrome; Pulmonary Disease, Chronic Obstructive; Obesity; Pulmonary Fibrosis; Bronchiectasis; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Lung Diseases, Interstitial; Fibrosis

Study Officials

• Chiara G Beccaluva, MSc

  MedicAir Italia S.r.l.

  STUDY CHAIR

• Michele Vitacca, MD

  ICS Maugeri - IRCCS Lumezzane

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara G Beccaluva, MSc

CONTACT

0039 342 107 7236; chiara.beccaluva@medicair.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 7, 2022
• Study Start: October 17, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)