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Digital App for Telerehabilitation in Respiratory Diseases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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.
- Full-day ventilotherapy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05572346
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

MedicAir Healthcare S.r.l.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Chiara G Beccaluva, MScMichele Vitacca, MD
Principal Investigator Affiliation MedicAir Italia S.r.l.ICS Maugeri - IRCCS Lumezzane
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Respiratory Disease, Asthma, Long COVID, Chronic Obstructive Pulmonary Disease, Obesity, Lung Fibrosis, Bronchiectasis
Additional Details

The center-based pulmonary rehabilitation (PR) intervention is considered the gold standard for functional recovery, secondary prevention, quality of life improvement and social as well as work reintegration in patients affected by respiratory diseases. Such kind of intervention, when delivered in all its fundamental components (clinical stabilization, functional assessment, physical and respiratory training, counseling, nutritional intervention and psychosocial support), is able to reduce global mortality and is recommended by the major international guidelines. Despite the high level of recommendation, only a small fraction of patients after the acute hospital phase is currently initiated to PR programs for several reasons, including the limited number of specialized rehabilitation facilities. This unmet need can cause a potential damage to patients' health (failure to reduce disability, higher risk of further pathological relapses) and generates an increase in social and healthcare costs, especially related to subsequent hospitalizations and loss of working capacity. In order to fill the gap between PR need and demand, health systems are have to adopt not only organizational changes but also to implement innovative solutions based on new technologies. In particular, wearables and mobile health devices seem to be promising tools to deliver a sort of "light PR intervention" promoting healthier lifestyle, even in the long term. Primary aim The primary objective of the study is to evaluate the feasibility and the medium-term effect on quality of life, measured by Visual Analogue Scale (VAS) contained in the EuroQoL 5D-5L questionnaire, of a digital home-based telerehabilitation program in patients with chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, pulmonary fibrosis, obesity and long COVID syndrome. Secondary aims The secondary objectives are: to evaluate the impact of the intervention on functional capacity through the Six-Minute Walking test (6MWT); evaluate changes in dyspnea perception; evaluate the impact of the intervention on spirometric indices; evaluate adherence to the intervention delivered via digital app; evaluate usability, satisfaction, adverse events and exacerbations during the intervention delivered through the digital app. Study design Monocentric, before-after study Assessment a baseline (T0) and after 8 weeks of intervention (T1) Population 30 patients discharged from the Pulmonary Rehabilitation Unit of ICS Maugeri

  • - IRCCS Lumezzane (Lumezzane - BS, Italy), affected by COPD, asthma, pulmonary fibrosis, bronchiectasis, obesity or long COVID syndrome.
Inclusion criteria Age ≥ 18 years old Diagnosis of COPD with Tiffenau index <70%, FEV1 <80%, asthma, bronchiectasis, pulmonary fibrosis, obesity (BMI > 30), long COVID syndrome Mini-mental status examination >22 Ability to perform a 6MWT with or without assistive devices Patients discharged from the Unit less than two weeks before the enrollment Written informed consent. Exclusion criteria 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 <10 g/dl) Pregnancy History of drugs abuse Total or partial inability to use digital devices Barriers to exercise training completion Full-day ventilotherapy. Materials and methods. At the hospital discharge (T0) a digital kit will be delivered in order to perform a home-based monitored telerehabilitation program. Using this kit, participants will undergo an 8-weeks exercise training and educational program to preserve the rehabilitative outcomes gained during hospital rehabilitation phase. Every week participants will undergo a video-coaching session with a respiratory physiotherapist. Primary endpoint Changes EuroQoL 5D-5L VAS score. Secondary endpoint Change in COPD Assessment Test (CAT) and EuroQoL (VAS excluded) scores Variation of 6MWT performance at 8 weeks (T1) compared to T0 Variations of mean, maximal and at rest saturation during 6MWT at T1 compared to T0 Variations of mean, maximal and at rest heart rate as well as fatigue perception during 6MWT at T1 compared to T0 Change in Barthel Dyspnea and Medical Research Council (MRC) scores Variations of spirometric parameters: FVC, FEV1, Tiffeneau index, FEF75, FEF50, FEF25, FEF25-75 Adherence (number of sessions completed/number of sessions programmed ratio) Satisfaction and user experience assessment with Technology Acceptance Model (TAM) Assessment of adverse events and number of pathological relapses. Sample size Considering a Minimal Clinical Important Difference of 8 points at EuroQoL VAS, a standard deviation of 15 points, an alpha error of 5% and a power of 80%, the estimated sample size will be of 30 participants. Statistical analysis Data will be synthetized using descriptive statistics: quantitative variables will be summarized with means and standard deviations or medians and interquartile ranges, as appropriate; categorical variables will be expressed as absolute frequencies and percentages. To assess outcomes changes following the 8-weeks intervention, parametric and non-parametric within group tests will be applied as appropriate. Correlations between variables will be assessed using partial correlation analysis. All the analyses will be conducted using SPSS 26 (IBM, Armonk, NY, USA). Ethical and regulatory considerations This study will be conducted in accordance with the principles laid down by the 18th World Medical Assembly (Helsinki, 1964) and all applicable amendments laid down by the World Medical Assemblies, and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines for Good Clinical Practice.

Arms & Interventions

Arms

: 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.

Interventions

Other: - Home-based telerehabilitation program delivered through digital devices

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

ICS Maugeri - IRCCS Lumezzane, Lumezzane, Brescia, Italy

Status

Recruiting

Address

ICS Maugeri - IRCCS Lumezzane

Lumezzane, Brescia,

Site Contact

Michele Vitacca, MD

michele.vitacca@icsmaugeri.it

0039 342 107 7236