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Tele-coaching in Patients With COVID-19

Primary Purpose

Covid19, Rehabilitation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring covid19, rehabilitation, telecoaching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being treated in intensive care unit due to COVID-19 pneumonia,
  • Receiving IMV, NIMV, or high-flow oxygen therapy
  • Patients whose respiratory symptoms persist despite discharge

Exclusion Criteria:

  • Patients with PCR test +
  • Patients without any complaints.
  • Patients who are hospitalized and discharged within 10 days
  • Patients with orthopedic, neurological, cognitive problems

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Telecoaching group

    Control Group

    Arm Description

    They will be given breathing exercise training and will be asked to do it every day for 8 weeks. In addition to breathing exercises, the use of incentive spirometry and aerobic exercise training will be provided. They will be asked to do breathing exercises, use of incentive spirometry and strengthening exercises for at least 20 minutes every day and 5 times a week. They will be called by phone once a week and encouraging speeches will be made.

    They will be given breathing exercise training and will be asked to do it every day. In addition to breathing exercises, the use of incentive spirometry and aerobic exercise training will be provided. They will be asked to do breathing exercises, use of incentive spirometry and strengthening exercises for at least 20 minutes every day and 5 times a week. There will be no interviews in the control group.

    Outcomes

    Primary Outcome Measures

    Exercise Capacity
    Six Minute- walk test

    Secondary Outcome Measures

    Dyspnea Assessment
    Medical Research Council Scale(MRC); the MRC dyspnea scale is a questionnaire that consists of five statements about perceived breathlessness. (min 1- max 5 point) Higher scores mean a worse outcome.
    Quality of Life Assessment
    St. George Respiratory Questionnaire; Scores range from 0 to 100, with higher scores indicating more limitations.
    Anxiety and Depression
    Hospital Anxiety and Depression (HAD); The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.

    Full Information

    First Posted
    February 27, 2021
    Last Updated
    March 9, 2021
    Sponsor
    Izmir Katip Celebi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04791072
    Brief Title
    Tele-coaching in Patients With COVID-19
    Official Title
    Effectiveness of Pulmonary Rehabilitation With Tele-coaching in Patients With COVID-19
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    March 1, 2021 (Anticipated)
    Study Completion Date
    March 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Izmir Katip Celebi University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Respiratory exercise training and aerobic exercise training will be given to patients who have been hospitalized in intensive care due to COVID 19 and underwent IMV, who were hospitalized in the service and underwent NIMV or high-flow oxygen inhalation, and whose respiratory symptoms persist after discharge. The patients in the study group will be called by phone once a week and a motivating conversation will be made. No control will be made to the control group. Before and after the training, 6-minute walking test, MRC dyspnea scale, SGRQ quality of life questionnaire and hospital anxiety depression scale will be applied.
    Detailed Description
    Some of the patients with COVID 19 pneumonia still have respiratory symptoms despite being treated. It has been reported that pulmonary rehabilitation programs applied in various models and in a small number to relieve or reduce these symptoms reduce dyspnea, increase exercise capacity and improve quality of life. There is no study reporting the results of a pulmonary rehabilitation program applied to COVID 19 patients in our country. The main purpose of this study is to determine the efficacy of pulmonary rehabilitation applied by telecoach to patients with severe COVID 19 pneumonia or persistent respiratory symptoms. Secondly, it is aimed to present the data of Turkish society to the literature. In accordance with this purpose investigators planed a randomised control clinical study. In our study respiratory exercise training and aerobic exercise training will be given to patients who have been hospitalized in intensive care due to COVID 19 and underwent IMV, who were hospitalized in the service and underwent NIMV or high-flow oxygen inhalation, and whose respiratory symptoms persist after discharge. The patients in the study group will be called by phone once a week and a motivating conversation will be made. No control will be made to the control group. Before and after the training, 6-minute walking test, MRC dyspnea scale, SGRQ quality of life questionnaire and hospital anxiety depression scale will be applied.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Covid19, Rehabilitation
    Keywords
    covid19, rehabilitation, telecoaching

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Telecoaching group
    Arm Type
    Experimental
    Arm Description
    They will be given breathing exercise training and will be asked to do it every day for 8 weeks. In addition to breathing exercises, the use of incentive spirometry and aerobic exercise training will be provided. They will be asked to do breathing exercises, use of incentive spirometry and strengthening exercises for at least 20 minutes every day and 5 times a week. They will be called by phone once a week and encouraging speeches will be made.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    They will be given breathing exercise training and will be asked to do it every day. In addition to breathing exercises, the use of incentive spirometry and aerobic exercise training will be provided. They will be asked to do breathing exercises, use of incentive spirometry and strengthening exercises for at least 20 minutes every day and 5 times a week. There will be no interviews in the control group.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    Breathing exercise training Use of incentive spirometry Aerobic exercise training Strengthening exercises
    Primary Outcome Measure Information:
    Title
    Exercise Capacity
    Description
    Six Minute- walk test
    Time Frame
    Change from baseline six minute walk distance at 8 week
    Secondary Outcome Measure Information:
    Title
    Dyspnea Assessment
    Description
    Medical Research Council Scale(MRC); the MRC dyspnea scale is a questionnaire that consists of five statements about perceived breathlessness. (min 1- max 5 point) Higher scores mean a worse outcome.
    Time Frame
    Change from baseline dyspnea at 8 week
    Title
    Quality of Life Assessment
    Description
    St. George Respiratory Questionnaire; Scores range from 0 to 100, with higher scores indicating more limitations.
    Time Frame
    Change from baseline quality of life at 8 week
    Title
    Anxiety and Depression
    Description
    Hospital Anxiety and Depression (HAD); The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
    Time Frame
    Change from baseline anxiety and depression at 8 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Being treated in intensive care unit due to COVID-19 pneumonia, Receiving IMV, NIMV, or high-flow oxygen therapy Patients whose respiratory symptoms persist despite discharge Exclusion Criteria: Patients with PCR test + Patients without any complaints. Patients who are hospitalized and discharged within 10 days Patients with orthopedic, neurological, cognitive problems

    12. IPD Sharing Statement

    Learn more about this trial

    Tele-coaching in Patients With COVID-19

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