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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077943
• Other study ID #: Home based Exercise PostCovid
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: February 20, 2023

Study information

• Verified date: February 2023
• Source: National Cardiovascular Center Harapan Kita Hospital Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 20, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breathing Exercise
• Cardiovascular Diseases
• COVID-19
• Covid19
• Respiratory Aspiration

Intervention

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.
• 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.

Locations

Country	Name	City	State
Indonesia	National Cardiovascular Center Harapan Kita Hospital Indonesia	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
National Cardiovascular Center Harapan Kita Hospital Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (9)

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. — View Citation

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. — View Citation

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):2003167. doi: 10.1183/13993003.03167-2020. Print 2020 Oct. — View Citation

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. — View Citation

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. — View Citation

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. No abstract available. — View Citation

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. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change of Hemoglobin	Hemoglobin (g/dL)	Change from Baseline Hemoglobin at 3 months
Secondary	Change of Hematocrit	Hematocrit (%)	Change from Baseline Hematocrit at 3 months
Secondary	Change of Erythrocyte	Erythrocyte (million/µL)	Change from Baseline Erythrocyte at 3 months
Secondary	Change of Mean Corpuscular Volume	Mean Corpuscular Volume (fL)	Change from Baseline Mean Corpuscular Volume at 3 months
Secondary	Change of Mean Corpuscular Hemoglobin	Mean Corpuscular Hemoglobin (pg)	Change from Baseline Mean Corpuscular Hemoglobin at 3 months
Secondary	Change of Mean Corpuscular Hemoglobin Concentration	Mean Corpuscular Hemoglobin Concentration (%)	Change from Baseline Mean Corpuscular Hemoglobin Concentration at 3 months
Secondary	Change of Red Cell Distribution Width	Red Cell Distribution Width (%)	Change from Baseline Red Cell Distribution Width at 3 months
Secondary	Change of Leucocyte	Leucocyte (/µL)	Change from Baseline Leucocyte at 3 months
Secondary	Change of Platelet	Platelet (thousand/µL)	Change from Baseline Platelet at 3 months
Secondary	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
Secondary	Change of Basophil	Basophil (/µL)	Change from Baseline Basophil at 3 months
Secondary	Change of Eosinophil	Eosinophil (/µL)	Change from Baseline Eosinophil at 3 months
Secondary	Change of Neutrophil	Neutrophil (/µL)	Change from Baseline Neutrophil at 3 months
Secondary	Change of Lymphocyte	Lymphocyte (/µL)	Change from Baseline Lymphocyte at 3 months
Secondary	Change of Monocyte	Monocyte (/µL)	Change from Baseline Monocyte at 3 months
Secondary	Change of C-Reactive Protein	to determine infection markers. Unit of measure : mg/L	Change from Baseline C-Reactive Protein at 3 months
Secondary	Change of D-dimer	Unit of measure : ng/mL	Change from Baseline D-dimer at 3 months