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Telerehabilitation in Patients With COVID-19 After Hospitalization. The ATHLOS Study (ATHLOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368845
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 21, 2020
Sponsor:
Collaborators:
University of Athens
University of Ioannina
University of Thessaly
Information provided by (Responsible Party):
Eleni Kortianou, Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory

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.


Condition or disease Intervention/treatment Phase
COVID-19 Comorbidities and Coexisting Conditions Device: Telerehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arm single blinded randomized control trial
Masking: Single (Outcomes Assessor)
Masking Description: Block Randomisation, Initial and final outcome assessors blinded to treatment arm
Primary Purpose: Treatment
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
Actual Study Start Date : May 11, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : March 2021


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: 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.



Primary Outcome Measures :
  1. Physical Performance [ Time Frame: Change From Baseline in SPPB Scores at 3 and 6 months ]
    The Short Physical Performance Battery (SPPB) is comprised of 3 tasks: a standing balance test (side by side, semi-tandem and tandem), a 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 points. The total score is 12 points and this represents the highest performance. It can be easily performed at home via video conferencing

  2. Cardiorespiratory fitness [ Time Frame: Change From Baseline in 3MST Scores at 3 and 6 months ]
    The 3 minute step test (3MST) is a field test designed to measure aerobic (cardiovascular) fitness. Participants step up and down a 30-cm high step for 3 minutes at a pace of 24 steps per minute. Oxygen saturation, heart rate and fatigue (using the Borg 0-10 scale) will be assessed at the beginning, at the end and every minute after full recovery in order to evaluate the heart's, fatigue and saturation recovery rates. Because it is a submaximal test it can easily be completed at home and administrated via video conferencing.

  3. Lower limb Strength [ Time Frame: Change From Baseline in STST Scores at 3 and 6 months ]
    The 30 sec sit-to-stand test (STST) is a feasible alternative for measuring lower limb muscle strength and endurance. The outcome is the number of times that the participant is able to completely stand up from the chair within 30 seconds.

  4. Health Related Quality of Life [ Time Frame: Change From Baseline in SF-36 Scores at 3 and 6 months ]
    The Short Form Health Survey (SF-36) consists of 36 questions spanning 8 health (physical and mental) domains. The eight domains are: vitality, physical functioning, bodily pain, general health, physical role functioning, emotional role functioning, social role and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Converging the individual scores into z-score, a standardized score (mean 50) is provided for each domain allowing comparisons between populations. The lower the score the more disability. It is a valid patient-reported survey of health-related quality of life in patient populations and it is responsive to change following therapeutic interventions.

  5. Anxiety and Depression [ Time Frame: Change From Baseline in HADS Scores at 3 and 6 months ]
    Hospital anxiety and depression scale (HADS) is a 14-item questionnaire for screening anxiety (7 items) and depression (7 items). Each item is scored from 0-3 (a 4-point severity scale). Highest anxiety or depression score is 21. Patients are defined as having anxiety or depression or both if the score is 8 or more in the each subscale

  6. Physical Activity [ Time Frame: Change From Baseline in IPAQ Scores at 3 and 6 months ]

    The International Physical Activity Questionnaire (IPAQ) is a frequently used instrument for the evaluation of physical activity (PA). It was developed in order to assess physical activity in adults aged 18-65 years. The greek version of IPAQ, (IPAQ-Gr) sums up moderate, vigorous, walking physical activities over the previous seven-day period and generate a total physical activity score (PAscore), expressed in MET-minutes per week (MET.min.wk-1 ).

    Based on the IPAQ scoring procedure, physical activity status is classified into three categories (PAclasses): (1) low PAclass, insufficiently active subjects (total PAscore < 600 MET.min.wk-1); (2) moderate PAclass (total PAscore ≥ 600 MET.min.wk-1 or vigorous PAscore ≥ 480 MET.min.wk-1) and (3) high PAclass (total PAscore ≥ 3000 MET.min.wk-1 or vigorous PAscore ≥ 1500 MET.min.wk-1).



Secondary Outcome Measures :
  1. Fatigue [ Time Frame: Change From Baseline in Borg CR-10 Scores at 3 and 6 months ]
    The Borg CR-10 (CR= scale range) scale is a rating scale for self-reported dyspnea. 0 represents no symptoms and 10 the worst previously experienced symptoms.

  2. Dyspnea [ Time Frame: Change From Baseline in MMRC Scores at 3 and 6 months ]
    The modified Medical Research Council Dyspnea Scale (MMRC). A score from 0-4 is used to classify the impact of dyspnea on physical function in patients with respiratory limitations. 0 represents a person who suffers from dyspnea only with strenuous exercise. 4 represents a person who are to breathless to leave the house, or breathless when dressing/undressing.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368845


Contacts
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Contact: ELENI KORTIANOU, PhD, PT 00306944665856 ekortianou@uth.gr
Contact: ELENI KAPRELI, PhD, PT 00306972423374 ekapreli@uth.gr

Locations
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Greece
Clinical exercise Physiology and rehabilitation research laboratory Recruiting
Lamia, Greece, 35100
Contact: Eleni Kortianou, PhD    00302231060235    ekortianou@uth.gr   
Contact: Eleni Kapreli, PhD    00302231060235    ekapreli@uth.gr   
Sponsors and Collaborators
Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory
University of Athens
University of Ioannina
University of Thessaly
Investigators
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Study Director: ELENI KORTIANOU, PhD, PT Clinical Exercise Physiology and Rehabilitation Research Laboratory
Study Chair: ELENI KAPRELI, PhD, PT Clinical Exercise Physiology and Rehabilitation Research Laboratory
Publications:
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Responsible Party: Eleni Kortianou, Associate Professor in Respiratory Physiotherapy, Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory
ClinicalTrials.gov Identifier: NCT04368845    
Other Study ID Numbers: 1
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eleni Kortianou, Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory:
covid-19
telerehabilitation
physiotherapy
home rehabilitation