The Effect of Home-based Exercise on Functional Capacity of Covid-19 Survivor With Cardiovascular Comorbidity

Study Overview
=================
Brief Summary
-----------------
Objective propose: to investigate the effect of home based breathing exercise and chest mobilization on the cardiorespiratory functional capacity of Covid-19 survivors with cardiovascular comorbidity. Breathing exercise and chest mobilization are proven to increase lung functional capacity in Covid-19 survivors. It is hypothesized that breathing exercise and chest mobilization in Covid-19 survivors will give benefits to Covid-19 survivors with cardiovascular disease.

Detailed Description
-----------------
Lung restrictive disorder is one of the reasons that induce chronic fatigue in COVID-19 (Corona Virus Disease-19) survivors. It also gives a significant effect on cardiovascular patients who are in the second phase of cardiac rehabilitation. Breathing exercise and chest mobilization are proven to increase lung functional capacity in Covid-19 survivors. On the other hand, there is still no research that shows the effectiveness of Breathing exercises and chest mobilization in Covid-19 survivors who are suffering from cardiovascular problems. Patients in National Cardiac Center Hospital, Jakarta, with a history of Covid-19 and have cardiovascular disease are recruited. They will undergo pre and post-exercise examinations such as blood sampling, do 6 minutes walking test, Peak Cough Flow and Peak Flow Rate test, measuring the chest dimension, treadmill, and answer the European Quality of Life Five Dimension (EQ-5D) questions. With randomization, patients will be determined to treatment or control group. They will be prepared about what exercises should they do at home. Subjects will be supervised digitally and regularly through Zoom meetings. Exercises will be done for 3 months.

Official Title
-----------------
The Effect of Home-based Breathing and Chest Mobilisation Exercise on Cardiorespiratory Functional Capacity of Covid-19 Survivor With Cardiovascular Comorbidity

Conditions
-----------------
Covid19, Breathing Exercise, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Behavioral: Breathing and chest mobilization exercises
* Behavioral: Second phase cardiac rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who got infected by Covid-19 in 3 months before recruitment and suffering cardiovascular disease Able to communicate and operate Youtube and Zoom. Exclusion Criteria: Limitation to move any part of the body that causes the inability to do the instructed exercise. Feel pain in extremities (visual analog scale >3) Chronic Obstructive Pulmonary Disease Neuromuscular disorder (stroke, peripheral neuropathy with significant motoric control disturbance Musculoskeletal disorder (fracture, post amputation, severe arthritis in support joints)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No Breathing Exercise<br>Patients will do the second phase of cardiac rehabilitation for minimum 5 times per week, 30 minutes each time, in 3 months without being supervised | Behavioral: Second phase cardiac rehabilitation<br>* Independently, patients walk regularly 5 times per week and increase the distance day by day according to their improved ability without breathing and chest mobilization exercise.<br>|
| Experimental: With Breathing Exercise<br>Patients will do the second phase of cardiac rehabilitation for minimum 5 times per week, 30 minutes each time and breathing and chest mobilization exercise for 3 times per week. They will be supervised through online meetings. | Behavioral: Breathing and chest mobilization exercises<br>* Patients walk regularly 5 times per week and increase the distance day by day according to their improved ability. Patients also do breathing and chest mobilization exercise 3 times per week. It is a recorded moderated exercise for 30 minutes duration. Patients can access the video as a home-based activity through an online videos platform and will be supervised.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Peak Cough Flow (PC) | to define the functional capacity. Unit of measure : L/min. | Change from Baseline Peak Cough Flow (PC) at 3 months | 
| Change of Peak Flow Rate (PFR) | to define the functional capacity. Unit of measure : L/min. | Change from Baseline Peak Flow Rate (PFR) at 3 months | 
| Change of Cardiac Exercise Test | Patients walk on treadmill. Unit of measure : minutes, METs (Metabolic Equivalent of Task) | Change from Baseline Cardiac Exercise Test at 3 months | 
| Change of 6-minutes walking test | To define initial ability to walk in 30 minutes for second phase cardiac rehabilitation (aerobic exercise). Unit of measure : meter | Change from Baseline 6-minutes walking test at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Hemoglobin | Hemoglobin (g/dL) | Change from Baseline Hemoglobin at 3 months | 
| Change of Hematocrit | Hematocrit (%) | Change from Baseline Hematocrit at 3 months | 
| Change of Erythrocyte | Erythrocyte (million/µL) | Change from Baseline Erythrocyte at 3 months | 
| Change of Mean Corpuscular Volume | Mean Corpuscular Volume (fL) | Change from Baseline Mean Corpuscular Volume at 3 months | 
| Change of Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin (pg) | Change from Baseline Mean Corpuscular Hemoglobin at 3 months | 
| Change of Mean Corpuscular Hemoglobin Concentration | Mean Corpuscular Hemoglobin Concentration (%) | Change from Baseline Mean Corpuscular Hemoglobin Concentration at 3 months | 
| Change of Red Cell Distribution Width | Red Cell Distribution Width (%) | Change from Baseline Red Cell Distribution Width at 3 months | 
| Change of Leucocyte | Leucocyte (/µL) | Change from Baseline Leucocyte at 3 months | 
| Change of Platelet | Platelet (thousand/µL) | Change from Baseline Platelet at 3 months | 
| Change of European Quality of Life Five Dimension (EQ-5D) | 1=have no problem, 2=have slight problem, 3=moderate problem, 4=severe problem, 5=unable to do. We will compare the points between pre and post exercise and looking the improvement. | Change from Baseline EQ-5D at 3 months | 
| Change of Basophil | Basophil (/µL) | Change from Baseline Basophil at 3 months | 
| Change of Eosinophil | Eosinophil (/µL) | Change from Baseline Eosinophil at 3 months | 
| Change of Neutrophil | Neutrophil (/µL) | Change from Baseline Neutrophil at 3 months | 
| Change of Lymphocyte | Lymphocyte (/µL) | Change from Baseline Lymphocyte at 3 months | 
| Change of Monocyte | Monocyte (/µL) | Change from Baseline Monocyte at 3 months | 
| Change of C-Reactive Protein | to determine infection markers. Unit of measure : mg/L | Change from Baseline C-Reactive Protein at 3 months | 
| Change of D-dimer | Unit of measure : ng/mL | Change from Baseline D-dimer at 3 months |