Telerehabilitation in Patients With COVID-19 After Hospitalization. The ATHLOS Study
Condition: COVID-19; Comorbidities and Coexisting Conditions
MeSH terms: COVID-19
Study type: Interventional

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.
    

Intervention name(s): Telerehabilitation
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two arm single blinded randomized control trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: covid-19; telerehabilitation; physiotherapy; home rehabilitation