Tele-coaching in Patients With COVID-19

Not Applicable

• Conditions: Rehabilitation; Covid19
• Interventions: Other: Exercise

• Registration Number: NCT04791072
• Lead Sponsor: Izmir Katip Celebi University

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.

Study Timeline

• Study First Submitted: 2021-02-27
• Status Verified: 2021-03
• Study Start: 2021-03-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Study First Submitted QC: 2021-03-09
• Last Update Submitted: 2021-03-09
• Study First Posted: 2021-03-10
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Exercise	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.
Telecoaching group	Exercise	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.

Primary Outcome Measures

Name	Time	Method
Exercise Capacity	Change from baseline six minute walk distance at 8 week	Six Minute- walk test

Secondary Outcome Measures

Name	Time	Method
Quality of Life Assessment	Change from baseline quality of life at 8 week	St. George Respiratory Questionnaire; Scores range from 0 to 100, with higher scores indicating more limitations.
Dyspnea Assessment	Change from baseline dyspnea at 8 week	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.
Anxiety and Depression	Change from baseline anxiety and depression at 8 week	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.