Clinical trial NCT04368845: Telerehabilitation in Patients With COVID-19 After Hospitalization. The ATHLOS Study
Official title: A Telerehabilitation Approach to Improve Long-term Physical Ability and Quality of Life in Patients With Severe Acute Respiratory Syndrome Coronavirus (SARSCoV-2, COVID-19) Immediately After Hospitalization. The ATHLOS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Comorbidities and Coexisting Conditions
Keywords: covid-19
telerehabilitation
physiotherapy
home rehabilitation
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: University of Athens
name: University of Ioannina
First posted: 2020-04-30
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm single blinded randomized control trial
Primary purpose: TREATMENT

Brief summary: This is a two-phase multicenter study that will be conducted in collaboration with five university hospitals, in order to offer telehealth services at home 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).

At the second phase a randomized control trial study will evaluate a 6-month telerehabilitation program for 100 adults (aged 20-65 years) diagnosed with COVID-19, who completed the first phase of this study. At this phase, the study 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 program includes individualized prescribed endurance exercises, low intensity 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Physical Performance
timeFrame: Change From Baseline in SPPB Scores at 3 and 6 months
measure: Cardiorespiratory fitness
timeFrame: Change From Baseline in 3MST Scores at 3 and 6 months
measure: Lower limb Strength
timeFrame: Change From Baseline in STST Scores at 3 and 6 months
measure: Health Related Quality of Life
timeFrame: Change From Baseline in SF-36 Scores at 3 and 6 months
measure: Anxiety and Depression
timeFrame: Change From Baseline in HADS Scores at 3 and 6 months
measure: Physical Activity
timeFrame: Change From Baseline in IPAQ Scores at 3 and 6 months
Secondary outcomes:
measure: Fatigue
timeFrame: Change From Baseline in Borg CR-10 Scores at 3 and 6 months
measure: Dyspnea
timeFrame: Change From Baseline in MMRC Scores at 3 and 6 months
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: Clinical exercise Physiology and rehabilitation research laboratory
Study officials:
affiliation: Clinical Exercise Physiology and Rehabilitation Research Laboratory
name: ELENI KORTIANOU, PhD, PT
role: STUDY_DIRECTOR
affiliation: Clinical Exercise Physiology and Rehabilitation Research Laboratory
name: ELENI KAPRELI, PhD, PT
role: STUDY_CHAIR
References:
citation: Papathanasiou G, Georgoudis G, Papandreou M, Spyropoulos P, Georgakopoulos D, Kalfakakou V, Evangelou A. Reliability measures of the short International Physical Activity Questionnaire (IPAQ) in Greek young adults. Hellenic J Cardiol. 2009 Jul-Aug;50(4):283-94.
citation: Bergland A, Strand BH. Norwegian reference values for the Short Physical Performance Battery (SPPB): the Tromso Study. BMC Geriatr. 2019 Aug 8;19(1):216. doi: 10.1186/s12877-019-1234-8.
citation: Wassenberg MW, Severs D, Bonten MJ. Psychological impact of short-term isolation measures in hospitalised patients. J Hosp Infect. 2010 Jun;75(2):124-7. doi: 10.1016/j.jhin.2010.01.023. Epub 2010 Apr 10.