The Effect of Home-based Exercise on Functional Capacity of Covid-19 Survivor With Cardiovascular Comorbidity
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: No Breathing Exercise 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
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.
|
| Experimental: With Breathing Exercise 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
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.
|
Outcome Measures
Primary Outcome Measures
- Change of Peak Cough Flow (PC) [Change from Baseline Peak Cough Flow (PC) at 3 months]
to define the functional capacity. Unit of measure : L/min.
- Change of Peak Flow Rate (PFR) [Change from Baseline Peak Flow Rate (PFR) at 3 months]
to define the functional capacity. Unit of measure : L/min.
- Change of Cardiac Exercise Test [Change from Baseline Cardiac Exercise Test at 3 months]
Patients walk on treadmill. Unit of measure : minutes, METs (Metabolic Equivalent of Task)
- Change of 6-minutes walking test [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 Outcome Measures
- Change of Hemoglobin [Change from Baseline Hemoglobin at 3 months]
Hemoglobin (g/dL)
- Change of Hematocrit [Change from Baseline Hematocrit at 3 months]
Hematocrit (%)
- Change of Erythrocyte [Change from Baseline Erythrocyte at 3 months]
Erythrocyte (million/µL)
- Change of Mean Corpuscular Volume [Change from Baseline Mean Corpuscular Volume at 3 months]
Mean Corpuscular Volume (fL)
- Change of Mean Corpuscular Hemoglobin [Change from Baseline Mean Corpuscular Hemoglobin at 3 months]
Mean Corpuscular Hemoglobin (pg)
- Change of Mean Corpuscular Hemoglobin Concentration [Change from Baseline Mean Corpuscular Hemoglobin Concentration at 3 months]
Mean Corpuscular Hemoglobin Concentration (%)
- Change of Red Cell Distribution Width [Change from Baseline Red Cell Distribution Width at 3 months]
Red Cell Distribution Width (%)
- Change of Leucocyte [Change from Baseline Leucocyte at 3 months]
Leucocyte (/µL)
- Change of Platelet [Change from Baseline Platelet at 3 months]
Platelet (thousand/µL)
- Change of European Quality of Life Five Dimension (EQ-5D) [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.
- Change of Basophil [Change from Baseline Basophil at 3 months]
Basophil (/µL)
- Change of Eosinophil [Change from Baseline Eosinophil at 3 months]
Eosinophil (/µL)
- Change of Neutrophil [Change from Baseline Neutrophil at 3 months]
Neutrophil (/µL)
- Change of Lymphocyte [Change from Baseline Lymphocyte at 3 months]
Lymphocyte (/µL)
- Change of Monocyte [Change from Baseline Monocyte at 3 months]
Monocyte (/µL)
- Change of C-Reactive Protein [Change from Baseline C-Reactive Protein at 3 months]
to determine infection markers. Unit of measure : mg/L
- Change of D-dimer [Change from Baseline D-dimer at 3 months]
Unit of measure : ng/mL
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who got infected by Covid-19 in 3 months before recruitment and suffering cardiovascular disease
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Able to communicate and operate Youtube and Zoom.
Exclusion Criteria:
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Limitation to move any part of the body that causes the inability to do the instructed exercise.
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Feel pain in extremities (visual analog scale >3)
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Chronic Obstructive Pulmonary Disease
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Neuromuscular disorder (stroke, peripheral neuropathy with significant motoric control disturbance
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Musculoskeletal disorder (fracture, post amputation, severe arthritis in support joints)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Cardiovascular Center Harapan Kita Hospital Indonesia | Jakarta | Indonesia | 11420 |
Sponsors and Collaborators
- National Cardiovascular Center Harapan Kita Hospital Indonesia
Investigators
- Principal Investigator: Bambang Dwiputra, MD, FIHA, National Cardiovascular Center Harapan Kita Hospital Indonesia
Study Documents (Full-Text)
None provided.More Information
Publications
- 1. WHO Indonesia. Coronavirus Disease 2019 (COVID-19) Situation Report-36. [Internet]. WHO; [2020 Dec 2; cited 2021 Feb 12]. Available from: https://www.who.int/indonesia/news/novel-coronavirus/situation-reports
- 9. ESC. Recommendations on how to provide cardiac rehabilitation activities during the COVID-19 pandemic. [Internet] France: European Society of Cardiology; [2020 Apr 8; cited in 2021 Feb 12]. Available from: https://www.escardio.org/Education/Practice-Tools/CVD-prevention-toolbox/recommendations-on-how-to-provide-cardiac-rehabilitation-activities-during-the-c
- Abdullahi A. Safety and Efficacy of Chest Physiotherapy in Patients With COVID-19: A Critical Review. Front Med (Lausanne). 2020 Jul 21;7:454. doi: 10.3389/fmed.2020.00454. eCollection 2020. Review.
- Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.
- Eapen MS, Lu W, Gaikwad AV, Bhattarai P, Chia C, Hardikar A, Haug G, Sohal SS. Endothelial to mesenchymal transition: a precursor to post-COVID-19 interstitial pulmonary fibrosis and vascular obliteration? Eur Respir J. 2020 Oct 15;56(4). pii: 2003167. doi: 10.1183/13993003.03167-2020. Print 2020 Oct.
- Halpin SJ, McIvor C, Whyatt G, Adams A, Harvey O, McLean L, Walshaw C, Kemp S, Corrado J, Singh R, Collins T, O'Connor RJ, Sivan M. Postdischarge symptoms and rehabilitation needs in survivors of COVID-19 infection: A cross-sectional evaluation. J Med Virol. 2021 Feb;93(2):1013-1022. doi: 10.1002/jmv.26368. Epub 2020 Aug 17.
- Ogura A, Izawa KP, Tawa H, Kureha F, Wada M, Harada N, Ikeda Y, Kimura K, Kondo N, Kanai M, Kubo I, Yoshikawa R, Matsuda Y. Impact of the COVID-19 pandemic on phase 2 cardiac rehabilitation patients in Japan. Heart Vessels. 2021 Aug;36(8):1184-1189. doi: 10.1007/s00380-021-01783-5. Epub 2021 Jan 29.
- Salman D, Vishnubala D, Le Feuvre P, Beaney T, Korgaonkar J, Majeed A, McGregor AH. Returning to physical activity after covid-19. BMJ. 2021 Jan 8;372:m4721. doi: 10.1136/bmj.m4721.
- Sardari A, Tabarsi P, Borhany H, Mohiaddin R, Houshmand G. Myocarditis detected after COVID-19 recovery. Eur Heart J Cardiovasc Imaging. 2021 Jan 1;22(1):131-132. doi: 10.1093/ehjci/jeaa166.
- Home based Exercise PostCovid