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

NCT04368845 | Completed DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Comorbidities and Coexisting Conditions

Keywords

covid-19; telerehabilitation; physiotherapy; home rehabilitation

Outcome Measures

Primary Outcomes (6)

• Physical Performance

  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

  Change From Baseline in SPPB Scores at 3 and 6 months

• Cardiorespiratory fitness

  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.

  Change From Baseline in 3MST Scores at 3 and 6 months

• Lower limb Strength

  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.

  Change From Baseline in STST Scores at 3 and 6 months

• Health Related Quality of Life

  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.

  Change From Baseline in SF-36 Scores at 3 and 6 months

• Anxiety and Depression

  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

  Change From Baseline in HADS Scores at 3 and 6 months

• Physical Activity

  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).

  Change From Baseline in IPAQ Scores at 3 and 6 months

Secondary Outcomes (2)

• Fatigue

  Change From Baseline in Borg CR-10 Scores at 3 and 6 months

• Dyspnea

  Change From Baseline in MMRC Scores at 3 and 6 months

Study Arms (2)

Experimental Intervention Arm: Telerehabilitation

ACTIVE COMPARATOR

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

No Intervention: Conventional teleconference

NO INTERVENTION

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.

Interventions

Telerehabilitation DEVICE

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.

Experimental Intervention Arm: Telerehabilitation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults with age from 20 to 65 years hospitalized due COVID-19 infection. Able to give consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead
• University of Athens: collaborator
• University of Ioannina: collaborator

Study Sites (1)

Clinical exercise Physiology and rehabilitation research laboratory

Lamia, 35100, Greece

Location

Related Publications (3)

• 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.

  PMID: 19622498 BACKGROUND

• 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.

  PMID: 31395008 BACKGROUND

• 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.

  PMID: 20381912 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• ELENI KORTIANOU, PhD, PT

  Clinical Exercise Physiology and Rehabilitation Research Laboratory

  STUDY DIRECTOR

• ELENI KAPRELI, PhD, PT

  Clinical Exercise Physiology and Rehabilitation Research Laboratory

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Block Randomisation, Initial and final outcome assessors blinded to treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Respiratory Physiotherapy

Model Details: Two arm single blinded randomized control trial

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 30, 2020
• Study Start: April 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: July 31, 2021
• Last Updated: December 28, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)