Tele-coaching in Patients With COVID-19

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

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 Overview

• Status: Unknown
• Conditions: Covid19; Rehabilitation
• Intervention / Treatment: Other: Exercise

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telecoaching group; 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.	Other: Exercise; Breathing exercise training Use of incentive spirometry Aerobic exercise training Strengthening exercises
Active Comparator: Control Group; 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.	Other: Exercise; Breathing exercise training Use of incentive spirometry Aerobic exercise training Strengthening exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Capacity	Six Minute- walk test	Change from baseline six minute walk distance at 8 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: rehabilitation; covid19; telecoaching
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IKCSS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No