Clinical trial NCT05077943: The Effect of Home-based Exercise on Functional Capacity of Covid-19 Survivor With Cardiovascular Comorbidity
Official title: The Effect of Home-based Breathing and Chest Mobilisation Exercise on Cardiorespiratory Functional Capacity of Covid-19 Survivor With Cardiovascular Comorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Breathing Exercise
Cardiovascular Diseases
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Change of Peak Cough Flow (PC)
timeFrame: Change from Baseline Peak Cough Flow (PC) at 3 months
measure: Change of Peak Flow Rate (PFR)
timeFrame: Change from Baseline Peak Flow Rate (PFR) at 3 months
measure: Change of Cardiac Exercise Test
timeFrame: Change from Baseline Cardiac Exercise Test at 3 months
measure: Change of 6-minutes walking test
timeFrame: Change from Baseline 6-minutes walking test at 3 months
Secondary outcomes:
measure: Change of Hemoglobin
timeFrame: Change from Baseline Hemoglobin at 3 months
measure: Change of Hematocrit
timeFrame: Change from Baseline Hematocrit at 3 months
measure: Change of Erythrocyte
timeFrame: Change from Baseline Erythrocyte at 3 months
measure: Change of Mean Corpuscular Volume
timeFrame: Change from Baseline Mean Corpuscular Volume at 3 months
measure: Change of Mean Corpuscular Hemoglobin
timeFrame: Change from Baseline Mean Corpuscular Hemoglobin at 3 months
measure: Change of Mean Corpuscular Hemoglobin Concentration
timeFrame: Change from Baseline Mean Corpuscular Hemoglobin Concentration at 3 months
measure: Change of Red Cell Distribution Width
timeFrame: Change from Baseline Red Cell Distribution Width at 3 months
measure: Change of Leucocyte
timeFrame: Change from Baseline Leucocyte at 3 months
measure: Change of Platelet
timeFrame: Change from Baseline Platelet at 3 months
measure: Change of European Quality of Life Five Dimension (EQ-5D)
timeFrame: Change from Baseline EQ-5D at 3 months
measure: Change of Basophil
timeFrame: Change from Baseline Basophil at 3 months
measure: Change of Eosinophil
timeFrame: Change from Baseline Eosinophil at 3 months
measure: Change of Neutrophil
timeFrame: Change from Baseline Neutrophil at 3 months
measure: Change of Lymphocyte
timeFrame: Change from Baseline Lymphocyte at 3 months
measure: Change of Monocyte
timeFrame: Change from Baseline Monocyte at 3 months
measure: Change of C-Reactive Protein
timeFrame: Change from Baseline C-Reactive Protein at 3 months
measure: Change of D-dimer
timeFrame: Change from Baseline D-dimer at 3 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita Hospital Indonesia
Study officials:
affiliation: National Cardiovascular Center Harapan Kita Hospital Indonesia
name: Bambang Dwiputra, MD, FIHA
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
citation: 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