Tele-coaching in Patients With COVID-19

Covid19 Clinical Trial

Official title:

Effectiveness of Pulmonary Rehabilitation With Tele-coaching in Patients With COVID-19

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04791072
• Other study ID #: IKCSS
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Rehabilitation

Intervention

Other:
• Exercise
Breathing exercise training Use of incentive spirometry Aerobic exercise training Strengthening exercises

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Capacity	Six Minute- walk test	Change from baseline six minute walk distance at 8 week
Secondary	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.	Change from baseline dyspnea at 8 week
Secondary	Quality of Life Assessment	St. George Respiratory Questionnaire; Scores range from 0 to 100, with higher scores indicating more limitations.	Change from baseline quality of life at 8 week
Secondary	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.	Change from baseline anxiety and depression at 8 week