Clinical trial NCT04821934: Tele-rehabilitation Program After Hospitalization for COVID-19
Official title: Efficacy of a Tele-rehabilitation Program After Hospitalization for COVID-19 Pneumonia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pneumonia
Keywords: Covid-19
covid
pulmonary rehabilitation
physiotherapist
telerehabilitation
telemedicine
exercise
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: Istituto Auxologico Italiano
First posted: 2021-03-30
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Given the number of hospitalized subjects for COVID-19, the difficulties linked to the infectious risk, and the high cost of managing departments for COVID-19 subjects, the execution of home rehabilitation programs, in the form of telerehabilitation, was suggested as a viable option.

The aim of our study will be to investigate the effectiveness of a structured telerehabilitation program with a specific rehabilitation intervention on exercise tolerance at home in the subject discharged after hospitalization for COVID-19 pneumonia, in comparison to a traditional remote monitoring program (without any rehabilitation intervention).

Other secondary objectives will be the evaluation of safety, feasibility, clinical impact on symptom status (asthenia, dyspnea), gas exchange (day, night and under exertion), lung function, muscle strength, functional capacity and quality of life.

Detailed description: The rapid spread of Covid-19 has produced a large number of hospitalized patients, even for relatively long problems and with the need for intensive or sub-intensive care.

Upon discharge from the hospital, some studies have shown that the majority of subjects with COVID-19 present a reduction in functional capacity, exercise tolerance and muscle strength, regardless of previous health status and pre-existing disabilities. Furthermore, some works on patients suffering from similar respiratory infections, such as SARS or MERS, have described how a functional deficit can persist even in the long term. An early rehabilitation intervention, which included aerobic reconditioning, was tested in some pilot observational studies in hospitalized subjects for COVID-19, and proved feasible and safe. A single randomized controlled Chinese study has documented the efficacy of an acute respiratory rehabilitation intervention. Given the number of hospitalized subjects for COVID-19, the difficulties linked to the infectious risk, and the high cost of managing departments for COVID-19 subjects, the execution of home rehabilitation programs, in the form of telerehabilitation, was suggested as a viable option. Telerehabilitation programs that included effort re-conditioning, intended for subjects with reduced functional capacity, have already been successfully proposed in cardiac, respiratory, orthopedic, and neurological patients. No studies until now have described the feasibility, safety and efficacy of early exercise reconditioning treatment to improve disability in the subject discharged after hospitalization for COVID-19 pneumonia.

Eligibility criteria: Inclusion Criteria:

* One or both the following points:

  1. need for 24-hour oxygen therapy to have a resting SpO2 of at least 94% or exercise-induced desaturation, defined as a reduction of at least 3% of SpO2 mean measured during the 6-minute test (6MWT) compared to SpO2 measured at rest
  2. reduced tolerance to effort highlighted by the 6MWT with a value of the meters travelled less than 70 percent of the predicted one

Exclusion Criteria:

* Hemodynamic instability and the presence of uncontrolled cardiac arrhythmias
* Any clinical condition that contraindicates aerobic exercise
* Presence of motor disability before hospitalization which made it impossible to walk independently (Rankin scale\> 3) (10)
* Impaired cognitive status (Mini Mental State Examination test \<24)
* Inability to use (by the patient or a caregiver) the technological means sufficient to follow the program (mobile phone with internet connection)
* Lack of supervision by a caregiver in case of walking and standing instability Contacts/Locations

Primary outcomes:
measure: Change in 6 Minute Walking Test
timeFrame: baseline and 1 month and 3 months
Secondary outcomes:
measure: Respiratory evaluations
timeFrame: baseline and 1 month
measure: Respiratory muscle strength
timeFrame: baseline and 1 month
measure: Functional evaluations - 1 Minute Sit To Stand
timeFrame: baseline and 1 month
measure: Functional capacity with Short Physical Performance Battery (SPPB)
timeFrame: baseline and 1 month
measure: Clinical symptoms with Barthel Dyspnea Index
timeFrame: baseline and 1 month
measure: Fatigue Severity Scale
timeFrame: baseline and 1 month
measure: SF-12
timeFrame: baseline and 1 month
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: S Maugeri IRCCS, U.O. Emergenza Coronavirus di Lumezzane
city: Varese
country: Italy
facility: ICS Maugeri IRCCS, U.O. Emergenza Coronavirus di Tradate
Study officials:
affiliation: Istituti Clinici Scientifici Maugeri
name: Mara Paneroni, PT
role: PRINCIPAL_INVESTIGATOR
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