Functional Capacity in Survivors of COVID-19 Related ARDS

Sponsor
Koç University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04952844
Collaborator
(none)
15
Enrollment
1
Location
2
Anticipated Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Acute respiratory distress syndrome survivors frequently develop impaired physical function, muscle weakness and quality of life. The aim of this retrospective study is to determine the functional capacity, global muscle weakness and quality of life of COVID-19 survivors after 4 weeks following hospital discharge and the relationship between different tools. COVID-19 related acute respiratory distress syndrome survivors were assessed 4 weeks following discharge from the hospital, 15 patients who attended the evaluation will be included the study. All subjects underwent standardized physical clinical evaluation, Medical Research Council-sumscore, hand-grip strength, 6-minute walk test, chair-stand test, timed up and go test and Short form-36, 4 weeks after hospital discharge.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    COVID-19 could cause acute respiratory distress syndrome in a minority of patients. After recovery from acute critical illness and discharged from hospital, secondary disabilities related to Post Intensive Care Syndrome could take over the role. There is limited data and information about the functional capacity of these patients after hospital discharge.Follow-up these patients after discharge might help assessing the symptoms of Post Intensive Care Syndrome, functional capacity and need of physical therapy, therefore give care for the impairments. The aim of this retrospective cross-sectional study is to demonstrate the functional capacity, global muscle weakness and quality of life of COVID-19 survivors after 4 weeks following hospital discharge and the relationship between different tools. Appointment was given all of the ARDS survivors related to COVID-19 who treated in ICU after 4 weeks following discharge from hospital in order to assess the need of rehabilitation. 15 patients who attended the evaluation will be included the study.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    15 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Functional Capacity in Survivors of COVID-19 Related ARDS: A Cross-sectional Study
    Anticipated Study Start Date :
    Jul 1, 2021
    Anticipated Primary Completion Date :
    Aug 1, 2021
    Anticipated Study Completion Date :
    Sep 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Six-minute walk test [1 day]

      Six-minute walk test is a field test evaluating submaximal aerobic capacity. The technical standards are defined by European Respiratory Society and American Thoracic Society. The individuals were asked to walk as far as possible in a 30-meter corridor in 6 minutes and the distance, oxygen saturation, heart rate, systolic blood pressure and dyspnea scale (Borg 0-20) were recorded before and immediately after the test, and recovery period (1. minute of recovery). It is a valid and responsive measurement of functional capacity and also predicts quality of life in Acute respiratory distress syndrome survivors

    Secondary Outcome Measures

    1. Handgrip strength [1 day]

      Handgrip strength will be measured using a handheld dynamometer according to the instructions of the American Society of Hand Therapists. Patients will be requested to seat placing their arms by their sides with the elbow flexed to 90°, the forearm mid-prone, and the wrist in neutral position. Using standard verbal encouragement, patients will be asked to grip the dynamometer with dominant hand with maximal effort. Three trials will be performed with a 30-second interval between trials and the highest value will be recorded in kg. The cut-off values of grip strength are 28.6 kg in men and 16.4 kg in women.

    2. Medical Research Council-sumscore [1 day]

      It is valid and reliable tool in survivors of critical illness, it will be used in order to evaluate the overall muscle strength

    3. Short form - 36 [1 day]

      Short form - 36 measures health related quality of life. It is a self-reported survey that evaluates individual health status with eight parameters consisting of physical function, pain, role limitations attributed to physical problems, role limitations attributed to emotional problems, mental health, social functioning, energy/ vitality, general health perception. There is not a summary score, each section is scored between 0-100, 0 indicates the worst condition, 100 indicates the best.

    4. Chair stand test [1 day]

      It is used to evaluate strength and endurance of lower limbs. Patients will be asked to sit on a chair with a 46 cm seat height by crossing their hands over their chest and stand and sit five times consecutively as fast as possible. The test starts in the sitting position and terminate at the last sitting position and the time will be recorded.

    5. timed up and go test [1 day]

      The test will be used to assess physical function. It is an objective, reliable and simple test to evaluate both balance and functional movement. The patients will be asked to get up from a chair, walk 3 m, turn around, walk back and sit on the chair again. The time will be recorded in seconds.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • to be older that 18 years

    • Acute respiratory distress syndrome survivors related to COVID-19 who treated in Intensive care unit and attend appointment after 4 weeks following discharge from hospital

    Exclusion Criteria:
    • History of diseases that could affect functional capacity, muscle strength and quality of life, such as cancer, spinal cord disease, neuromuscular diseases

    • do not want to attend the study

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Koc University School of MedicineIstanbulTurkey34010

    Sponsors and Collaborators

    • Koç University

    Investigators

    • Principal Investigator: Ozden Ozyemisci Taskiran, Prof, Koc University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Koç University
    ClinicalTrials.gov Identifier:
    NCT04952844
    Other Study ID Numbers:
    • 2021.014.IRB1.008
    First Posted:
    Jul 7, 2021
    Last Update Posted:
    Jul 7, 2021
    Last Verified:
    Jul 1, 2021
    Keywords provided by Koç University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 7, 2021