Tele-rehabilitation Program After Hospitalization for COVID-19

Sponsor

Istituti Clinici Scientifici Maugeri SpA (Other)

Overall Status

Completed

CT.gov ID

NCT04821934

Collaborator

Istituto Auxologico Italiano (Other)

Enrollment

Locations

Arms

8.8

Actual Duration (Months)

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia	Other: TR Other: TSu	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Efficacy of a Tele-rehabilitation Program After Hospitalization for COVID-19 Pneumonia: a Randomized Controlled Trial

Actual Study Start Date :

Mar 26, 2021

Actual Primary Completion Date :

Dec 20, 2021

Actual Study Completion Date :

Dec 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telerehabilitation (TR) at home + Telesurveillance program (TSu) These COVID-19 patients will enter the usual telesurveillance program together with a specific remote rehabilitation program on exercise activity.	Other: TR TR is a specific remote tele rehabilitation program on exercise activity managed by the physiotherapist (PT) at home, this is the experimental group. PT will explain the rehabilitation program at hospital discharge by the use of a brochure and videos. TR will include an early exercise re-conditioning program [aerobic exercise at the free body (with or without tools), cyclette and walking with a pedometer] comprising 20 sessions of 60 minutes/day, 6 out of 7 days to be performed at home, for one month after discharge. The sessions will be self-managed by the patients 4 times a week and an expert PT will remotely supervise 2 times a week through a dedicated platform. The program will be progressively incremental and divided into 4 different levels of intensity (0- 3). In addition to this specific rehabilitation program, the patients will be followed by a nurse tutor once a day for two weeks and once a week for a further two weeks in a program of Telesurveillance. Other Names: Telerehabilitation
Active Comparator: Telesurveillance (TSu) alone These COVID-19 patients will enter the usual remote telesurveillance program	Other: TSu The patients of this group will perform a usual Telesurveillance and will be considered as control group. All patients, at discharge from the hospital, will be provided with a finger pulse oximeter and a dedicated application (app) on their personal smartphone and will be advised on free physical activity to be performed at home. The nurse will check through scheduled calls (once a day for two weeks and once a week for a further two weeks) the patient's health condition, vital parameters and drugs administration. Patients will be able to contact the nurse at each time, in case of specific need, out of the scheduled call, 7/7 days. A follow up by phone will be planned by nurse tutor at 2 months from the end of the study. Other Names: Telesurveillance

Arm

Intervention/Treatment

Experimental: Telerehabilitation (TR) at home + Telesurveillance program (TSu)

These COVID-19 patients will enter the usual telesurveillance program together with a specific remote rehabilitation program on exercise activity.

Other: TR

TR is a specific remote tele rehabilitation program on exercise activity managed by the physiotherapist (PT) at home, this is the experimental group. PT will explain the rehabilitation program at hospital discharge by the use of a brochure and videos. TR will include an early exercise re-conditioning program [aerobic exercise at the free body (with or without tools), cyclette and walking with a pedometer] comprising 20 sessions of 60 minutes/day, 6 out of 7 days to be performed at home, for one month after discharge. The sessions will be self-managed by the patients 4 times a week and an expert PT will remotely supervise 2 times a week through a dedicated platform. The program will be progressively incremental and divided into 4 different levels of intensity (0- 3). In addition to this specific rehabilitation program, the patients will be followed by a nurse tutor once a day for two weeks and once a week for a further two weeks in a program of Telesurveillance.

Other Names:

Telerehabilitation

Active Comparator: Telesurveillance (TSu) alone

These COVID-19 patients will enter the usual remote telesurveillance program

Other: TSu

The patients of this group will perform a usual Telesurveillance and will be considered as control group. All patients, at discharge from the hospital, will be provided with a finger pulse oximeter and a dedicated application (app) on their personal smartphone and will be advised on free physical activity to be performed at home. The nurse will check through scheduled calls (once a day for two weeks and once a week for a further two weeks) the patient's health condition, vital parameters and drugs administration. Patients will be able to contact the nurse at each time, in case of specific need, out of the scheduled call, 7/7 days. A follow up by phone will be planned by nurse tutor at 2 months from the end of the study.

Other Names:

Telesurveillance

Outcome Measures

Primary Outcome Measures

Change in 6 Minute Walking Test [baseline and 1 month and 3 months]
The 6MWT is a self-paced test of walking capacity. Patients will be asked to walk as far as possible in 6 min along a flat corridor. The distance in metres is recorded. Standardised instructions and encouragement are given during the test. Predicted 6MW Distance follows this calculation: 361-(age in yrs x 4) + (height in cm x 2) + (HRmax/HRmax % pred x 3) - (weight in kg x 1.5) - 30 (if females).

Secondary Outcome Measures

Respiratory evaluations [baseline and 1 month]
Measures of FiO2 (%), PaO2 (mmHg), PaCO2 (mmHg), pH
Respiratory muscle strength [baseline and 1 month]
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements may aid in evaluating respiratory muscle weakness. Patient needs to inspire and exhale into a rigid mouthpiece that does not allow the dispersion of the air blown by him. The mouthpiece is connected to a blood pressure monitor and is equipped with a valve that is closed before the patient breathes in or out with maximum force.
Functional evaluations - 1 Minute Sit To Stand [baseline and 1 month]
The therapists will ask the participants to sit down on a chair without arm rests and then up from the chair. The assisted use of the arms is not allowed during the STS test. The therapists will instruct the participants to complete as many sit-to-stand cycles as possible within 60 seconds at self-paced speed and count the number of fully-completed STS cycles. The median number of repetitions ranged from 50/min (25-75th percentile 41-57/min) in young men and 47/min (39-55/min) in young women aged 20-24 years to 30/min (25-37/min) in older men and 27/min (22-30/min) in older women aged 75-79 years.
Functional capacity with Short Physical Performance Battery (SPPB) [baseline and 1 month]
This is a test to evaluate lower limbs' function. The SPPB represents the sum of results from three functional tests: standing balance, 4-meter gait speed (4-MGS) and five-repetition sit-to-stand (5-STS) manoeuvre. Each component is scored based on a subscale, and the three sub-scores are added to obtain a summary score. Scores between 0-3 denote severe physical function disability, 4-6 low function, 7-9 intermediate function, and 10-12 normal function. Predicted values for the SPPB were calculated using normative values for total SPPB score and a European population aged ≥40 years, stratified for age and sex.
Clinical symptoms with Barthel Dyspnea Index [baseline and 1 month]
The Barthel Dyspnea Index is a scale used to measure patients' dyspnea during activity of daily living (ADL). It's composed by 10 items; the best score is 100 and higher is the score, less is the dyspnea.
Fatigue Severity Scale [baseline and 1 month]
The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities.
SF-12 [baseline and 1 month]
The SF-12 is a questionnaire with 12 questions to measure functional health and well-being (QoL) from the patient's perspective. It measures 8 health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Two summary scores are reported from the SF-12: a mental component score (MCS-12) and a physical component score (PCS-12). An algorithm establishes the score; lower values correspond to a worse quality of life, while higher values correspond to a better quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

One or both the following points:

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
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