NCT04832867

Brief Summary

It was aimed to evaluate the respiratory functions of patients who were given respiratory rehabilitation, bed positioning and early mobilization, and the time of leaving the hospital.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

March 27, 2021

Last Update Submit

April 3, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • GLASKOW COMA SCALE

    The scale was described in 1974 by Graham tesdale and Bryan Jenett as a way to communicate of patients with an acute brain injury. A person's GCS score can range from 3 (completely unresponsive) to 15 (responsive). This score is used to guide immediate medical care after a brain injury (such as a car accident) and also to monitor hospitalized patients and track their level of consciousness. The glasgow coma scale is often used to help define the severity of TBI. Mild head injuries are generally defined as those associated with a glasgow coma scale score of 13-15, and moderate head injuries are those associated with a glasgow coma scale score of 9-12. A glasgow coma scale score of 8 or less defines a severe head injury.

    change from baseline glaskow coma scale at 1 months

  • mMRC dyspnea scale

    THe mMRC dsypnea scale quantifies disability attributable to breathlessness and is useful for charecterizing baseline dyspnea in patients with respiratory disease. describes baseline dyspnea but does not accurately quantify response to treatment of chornic obstructive pulmonary disease (COPD).

    change from baseline at 1 month

Secondary Outcomes (3)

  • SpO2

    change from baseline at 1 month

  • carbon dioxide (CO2)

    change from baseline at 1 month

  • cardiac output test

    change from baseline at 1 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients in Hospital's service

You may qualify if:

  • Being over 18 years old
  • Those who have been hospitalized since 11.01.2020
  • Those who have been consulted to the physical therapy clinic since 11.01.2020

You may not qualify if:

  • Fever ˃38.0 °
  • Initial consultation time ˂7 days
  • In those with 3 days from the onset of the disease to shortness of breath Chest radiographic scans showing 50% progression within 24 to 48 hours
  • With Spo2 level ≤95%
  • Resting blood pressure ˂90 / 60 (1mmHg = 0.133kPa) or ˃140 / 90mmHg. 100 heart rate per minute Those with moderate and / or severe heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkor Dr. Sadi Konuk Research and Training hospital

Istanbul, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • meltem vural

    Bakırkoy Dr. Sadi Konuk Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 27, 2021

First Posted

April 6, 2021

Study Start

January 1, 2021

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

April 6, 2021

Record last verified: 2021-04

Locations