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Completed

NCT Number: NCT05077943

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

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.

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Key information

Conditions

Covid19 Breathing Exercise COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cardiovascular Center Harapan Kita Hospital Indonesia

Jakarta, 11420, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Breathing and chest mobilization exercises

Behavioral

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.

Second phase cardiac rehabilitation

Behavioral

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.

Primary outcomes

  1. Change of Peak Cough Flow (PC)

    Time frame: Change from Baseline Peak Cough Flow (PC) at 3 months

    to define the functional capacity. Unit of measure : L/min.

  2. Change of Peak Flow Rate (PFR)

    Time frame: Change from Baseline Peak Flow Rate (PFR) at 3 months

    to define the functional capacity. Unit of measure : L/min.

  3. Change of Cardiac Exercise Test

    Time frame: Change from Baseline Cardiac Exercise Test at 3 months

    Patients walk on treadmill. Unit of measure : minutes, METs (Metabolic Equivalent of Task)

  4. Change of 6-minutes walking test

    Time frame: Change from Baseline 6-minutes walking test at 3 months

    To define initial ability to walk in 30 minutes for second phase cardiac rehabilitation (aerobic exercise). Unit of measure : meter

Secondary outcomes

  1. Change of Hemoglobin

    Time frame: Change from Baseline Hemoglobin at 3 months

    Hemoglobin (g/dL)

  2. Change of Hematocrit

    Time frame: Change from Baseline Hematocrit at 3 months

    Hematocrit (%)

  3. Change of Erythrocyte

    Time frame: Change from Baseline Erythrocyte at 3 months

    Erythrocyte (million/µL)

  4. Change of Mean Corpuscular Volume

    Time frame: Change from Baseline Mean Corpuscular Volume at 3 months

    Mean Corpuscular Volume (fL)

  5. Change of Mean Corpuscular Hemoglobin

    Time frame: Change from Baseline Mean Corpuscular Hemoglobin at 3 months

    Mean Corpuscular Hemoglobin (pg)

  6. Change of Mean Corpuscular Hemoglobin Concentration

    Time frame: Change from Baseline Mean Corpuscular Hemoglobin Concentration at 3 months

    Mean Corpuscular Hemoglobin Concentration (%)

  7. Change of Red Cell Distribution Width

    Time frame: Change from Baseline Red Cell Distribution Width at 3 months

    Red Cell Distribution Width (%)

  8. Change of Leucocyte

    Time frame: Change from Baseline Leucocyte at 3 months

    Leucocyte (/µL)

  9. Change of Platelet

    Time frame: Change from Baseline Platelet at 3 months

    Platelet (thousand/µL)

  10. Change of European Quality of Life Five Dimension (EQ-5D)

    Time frame: Change from Baseline EQ-5D at 3 months

    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.

  11. Change of Basophil

    Time frame: Change from Baseline Basophil at 3 months

    Basophil (/µL)

  12. Change of Eosinophil

    Time frame: Change from Baseline Eosinophil at 3 months

    Eosinophil (/µL)

  13. Change of Neutrophil

    Time frame: Change from Baseline Neutrophil at 3 months

    Neutrophil (/µL)

  14. Change of Lymphocyte

    Time frame: Change from Baseline Lymphocyte at 3 months

    Lymphocyte (/µL)

  15. Change of Monocyte

    Time frame: Change from Baseline Monocyte at 3 months

    Monocyte (/µL)

  16. Change of C-Reactive Protein

    Time frame: Change from Baseline C-Reactive Protein at 3 months

    to determine infection markers. Unit of measure : mg/L

  17. Change of D-dimer

    Time frame: Change from Baseline D-dimer at 3 months

    Unit of measure : ng/mL

Sponsors and collaborators

Lead sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2021
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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