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

Primary Purpose

Covid19, Breathing Exercise, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Breathing and chest mobilization exercises
Second phase cardiac rehabilitation
Sponsored by
National Cardiovascular Center Harapan Kita Hospital Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • National Cardiovascular Center Harapan Kita Hospital Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No Breathing Exercise

With Breathing Exercise

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change of Peak Cough Flow (PC)
to define the functional capacity. Unit of measure : L/min.
Change of Peak Flow Rate (PFR)
to define the functional capacity. Unit of measure : L/min.
Change of Cardiac Exercise Test
Patients walk on treadmill. Unit of measure : minutes, METs (Metabolic Equivalent of Task)
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

Secondary Outcome Measures

Change of Hemoglobin
Hemoglobin (g/dL)
Change of Hematocrit
Hematocrit (%)
Change of Erythrocyte
Erythrocyte (million/µL)
Change of Mean Corpuscular Volume
Mean Corpuscular Volume (fL)
Change of Mean Corpuscular Hemoglobin
Mean Corpuscular Hemoglobin (pg)
Change of Mean Corpuscular Hemoglobin Concentration
Mean Corpuscular Hemoglobin Concentration (%)
Change of Red Cell Distribution Width
Red Cell Distribution Width (%)
Change of Leucocyte
Leucocyte (/µL)
Change of Platelet
Platelet (thousand/µL)
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 of Basophil
Basophil (/µL)
Change of Eosinophil
Eosinophil (/µL)
Change of Neutrophil
Neutrophil (/µL)
Change of Lymphocyte
Lymphocyte (/µL)
Change of Monocyte
Monocyte (/µL)
Change of C-Reactive Protein
to determine infection markers. Unit of measure : mg/L
Change of D-dimer
Unit of measure : ng/mL

Full Information

First Posted
September 29, 2021
Last Updated
February 21, 2023
Sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT05077943
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
February 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Breathing Exercise, Cardiovascular Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Breathing Exercise
Arm Type
Active Comparator
Arm Description
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
Arm Title
With Breathing Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Breathing and chest mobilization exercises
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Second phase cardiac rehabilitation
Intervention Description
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 Outcome Measure Information:
Title
Change of Peak Cough Flow (PC)
Description
to define the functional capacity. Unit of measure : L/min.
Time Frame
Change from Baseline Peak Cough Flow (PC) at 3 months
Title
Change of Peak Flow Rate (PFR)
Description
to define the functional capacity. Unit of measure : L/min.
Time Frame
Change from Baseline Peak Flow Rate (PFR) at 3 months
Title
Change of Cardiac Exercise Test
Description
Patients walk on treadmill. Unit of measure : minutes, METs (Metabolic Equivalent of Task)
Time Frame
Change from Baseline Cardiac Exercise Test at 3 months
Title
Change of 6-minutes walking test
Description
To define initial ability to walk in 30 minutes for second phase cardiac rehabilitation (aerobic exercise). Unit of measure : meter
Time Frame
Change from Baseline 6-minutes walking test at 3 months
Secondary Outcome Measure Information:
Title
Change of Hemoglobin
Description
Hemoglobin (g/dL)
Time Frame
Change from Baseline Hemoglobin at 3 months
Title
Change of Hematocrit
Description
Hematocrit (%)
Time Frame
Change from Baseline Hematocrit at 3 months
Title
Change of Erythrocyte
Description
Erythrocyte (million/µL)
Time Frame
Change from Baseline Erythrocyte at 3 months
Title
Change of Mean Corpuscular Volume
Description
Mean Corpuscular Volume (fL)
Time Frame
Change from Baseline Mean Corpuscular Volume at 3 months
Title
Change of Mean Corpuscular Hemoglobin
Description
Mean Corpuscular Hemoglobin (pg)
Time Frame
Change from Baseline Mean Corpuscular Hemoglobin at 3 months
Title
Change of Mean Corpuscular Hemoglobin Concentration
Description
Mean Corpuscular Hemoglobin Concentration (%)
Time Frame
Change from Baseline Mean Corpuscular Hemoglobin Concentration at 3 months
Title
Change of Red Cell Distribution Width
Description
Red Cell Distribution Width (%)
Time Frame
Change from Baseline Red Cell Distribution Width at 3 months
Title
Change of Leucocyte
Description
Leucocyte (/µL)
Time Frame
Change from Baseline Leucocyte at 3 months
Title
Change of Platelet
Description
Platelet (thousand/µL)
Time Frame
Change from Baseline Platelet at 3 months
Title
Change of European Quality of Life Five Dimension (EQ-5D)
Description
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.
Time Frame
Change from Baseline EQ-5D at 3 months
Title
Change of Basophil
Description
Basophil (/µL)
Time Frame
Change from Baseline Basophil at 3 months
Title
Change of Eosinophil
Description
Eosinophil (/µL)
Time Frame
Change from Baseline Eosinophil at 3 months
Title
Change of Neutrophil
Description
Neutrophil (/µL)
Time Frame
Change from Baseline Neutrophil at 3 months
Title
Change of Lymphocyte
Description
Lymphocyte (/µL)
Time Frame
Change from Baseline Lymphocyte at 3 months
Title
Change of Monocyte
Description
Monocyte (/µL)
Time Frame
Change from Baseline Monocyte at 3 months
Title
Change of C-Reactive Protein
Description
to determine infection markers. Unit of measure : mg/L
Time Frame
Change from Baseline C-Reactive Protein at 3 months
Title
Change of D-dimer
Description
Unit of measure : ng/mL
Time Frame
Change from Baseline D-dimer at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bambang Dwiputra, MD, FIHA
Organizational Affiliation
National Cardiovascular Center Harapan Kita Hospital Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cardiovascular Center Harapan Kita Hospital Indonesia
City
Jakarta
ZIP/Postal Code
11420
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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
Results Reference
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PubMed Identifier
32729939
Citation
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Results Reference
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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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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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.
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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.
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PubMed Identifier
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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.
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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.
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Results Reference
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The Effect of Home-based Exercise on Functional Capacity of Covid-19 Survivor With Cardiovascular Comorbidity

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