Telerehabilitation in Patients With COVID-19 After Hospitalization. The ATHLOS Study
Keywords
Abstract
Description
This is a two-phase multicenter study that will be conducted in collaboration with five university hospitals in order to offer home telehealth services in patients with COVID-19, after hospital discharge.
At the first phase, an observational study aims to investigate the physical and psychological status of patients after hospital discharge and to provide support and information how to cope with symptoms (early fatigue, muscle weakness, eating difficulties, etc).
We aim to support 200 patients with age 20-65 years, between a 1-8 week period after hospital discharge, providing an e-book with body exercises, breathing exercises and nutritional support, additionally to four telehealth consultation sessions.
At the second phase, a single blinded randomized control trial study will evaluate a 6-month home telerehabilitation program for 100 diagnosed with COVID-19 adults (aged 20-65 years), who completed the first phase of this study. The second phase will randomize (1:1 allocation) 100 male and female who were hospitalized with COVID-19 to either a 24-week home-based telerehabilitation program versus usual care.
The intervention includes individualized prescribed upper and lower extremity endurance exercises, aerobic exercises, upper and lower extremity strength training, breathing exercises as well as a three times per month online support with 1:1 supervision via video conferencing with an expert physiotherapist.
The usual care group will be advised to follow the instructions of the e-book for any possible exercise training. Three times per month with 1:1 video conferencing, an expert physiotherapist will record any possible exercise with no further recommendations or support.
Changes from baseline in physical activity levels, cardiorespiratory fitness, physical performance, lower limb strength, anxiety and depression and health-related quality of life will be assessed at 3 and 6 months for both groups. All functional tests in the second phase of the study will be performed via supervision teleconference for all the participants with an expert physiotherapist. Findings from this project will contribute to the field of telerehabilitation in patients with COVID-19 after hospital discharge and will provide critical preliminary data for the design and implementation of a larger, randomized control trial assessing the impact of telerehabilitation on long-term clinical outcomes following infection or re-infection from coronaviruses.
Dates
| Last Verified: | 03/31/2020 |
| First Submitted: | 04/19/2020 |
| Estimated Enrollment Submitted: | 04/27/2020 |
| First Posted: | 04/29/2020 |
| Last Update Submitted: | 05/18/2020 |
| Last Update Posted: | 05/20/2020 |
| Actual Study Start Date: | 05/10/2020 |
| Estimated Primary Completion Date: | 07/30/2020 |
| Estimated Study Completion Date: | 02/28/2021 |
Condition or disease
Intervention/treatment
Device: Experimental Intervention Arm: Telerehabilitation
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Experimental Intervention Arm: Telerehabilitation The treatment arm will be given up to 1-hour resistive training exercises, breathing exercises and aerobic exercises administered by an expert physiotherapist via teleconference (telerehabilitation). Every ten days one physiotherapist will record the individualized exercise program, will reevaluate the magnitude of exercise for each patient and reinforce to continue or increase exercise magnitude. | Device: Experimental Intervention Arm: Telerehabilitation The treatment arm will be given up to 1-hour breathing exercises, aerobic and resistive training exercises administered by a physiotherapist via a telerehabilitation device every 10 days for a six-month period. |
| No Intervention: No Intervention: Conventional teleconference The usual care arm will receive standard communication via teleconference every ten days for a six-month period without any specific recommendations and exercise prescription for home training. The control arm will be subject to the same assessments as the experimental arm at the start, and at the 3 and 6 months period. |
Eligibility Criteria
| Ages Eligible for Study | 20 Years To 20 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Male and female adults with age from 20 to 65 years hospitalized due COVID-19 infection. Able to give consent Exclusion Criteria: - the presence of mental illness, any physical disability that makes difficult to mobilize patients, severe heart disease, severe musculoskeletal pain, vascular aneurysms, severe neurological condition, pregnancy |
Outcome
Primary Outcome Measures
1. Physical Performance [Change From Baseline in SPPB Scores at 3 and 6 months]
2. Cardiorespiratory fitness [Change From Baseline in 3MST Scores at 3 and 6 months]
3. Lower limb Strength [Change From Baseline in STST Scores at 3 and 6 months]
4. Health Related Quality of Life [Change From Baseline in SF-36 Scores at 3 and 6 months]
5. Anxiety and Depression [Change From Baseline in HADS Scores at 3 and 6 months]
6. Physical Activity [Change From Baseline in IPAQ Scores at 3 and 6 months]
Secondary Outcome Measures
1. Fatigue [Change From Baseline in Borg CR-10 Scores at 3 and 6 months]
2. Dyspnea [Change From Baseline in MMRC Scores at 3 and 6 months]
