COVID-19 Clinical Trial
— ATHLOSOfficial 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
NCT number | NCT04368845 |
Other study ID # | 1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2020 |
Est. completion date | July 31, 2021 |
Verified date | January 2022 |
Source | University of Thessaly |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | July 31, 2021 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | Clinical exercise Physiology and rehabilitation research laboratory | Lamia |
Lead Sponsor | Collaborator |
---|---|
University of Thessaly | University of Athens, University of Ioannina |
Greece,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Fatigue | 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. | Change From Baseline in Borg CR-10 Scores at 3 and 6 months | |
Secondary | Dyspnea | 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. | Change From Baseline in MMRC Scores at 3 and 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|