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

February 21, 2023 updated by: Bambang Dwiputra, MD, National Cardiovascular Center Harapan Kita Hospital Indonesia

The Effect of Home-based Breathing and Chest Mobilisation Exercise on Cardiorespiratory 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 11420
        • National Cardiovascular Center Harapan Kita Hospital Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline Peak Cough Flow (PC) at 3 months
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.
Change from Baseline Peak Flow Rate (PFR) at 3 months
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)
Change from Baseline Cardiac Exercise Test at 3 months
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
Change from Baseline 6-minutes walking test at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Hemoglobin
Time Frame: Change from Baseline Hemoglobin at 3 months
Hemoglobin (g/dL)
Change from Baseline Hemoglobin at 3 months
Change of Hematocrit
Time Frame: Change from Baseline Hematocrit at 3 months
Hematocrit (%)
Change from Baseline Hematocrit at 3 months
Change of Erythrocyte
Time Frame: Change from Baseline Erythrocyte at 3 months
Erythrocyte (million/µL)
Change from Baseline Erythrocyte at 3 months
Change of Mean Corpuscular Volume
Time Frame: Change from Baseline Mean Corpuscular Volume at 3 months
Mean Corpuscular Volume (fL)
Change from Baseline Mean Corpuscular Volume at 3 months
Change of Mean Corpuscular Hemoglobin
Time Frame: Change from Baseline Mean Corpuscular Hemoglobin at 3 months
Mean Corpuscular Hemoglobin (pg)
Change from Baseline Mean Corpuscular Hemoglobin at 3 months
Change of Mean Corpuscular Hemoglobin Concentration
Time Frame: Change from Baseline Mean Corpuscular Hemoglobin Concentration at 3 months
Mean Corpuscular Hemoglobin Concentration (%)
Change from Baseline Mean Corpuscular Hemoglobin Concentration at 3 months
Change of Red Cell Distribution Width
Time Frame: Change from Baseline Red Cell Distribution Width at 3 months
Red Cell Distribution Width (%)
Change from Baseline Red Cell Distribution Width at 3 months
Change of Leucocyte
Time Frame: Change from Baseline Leucocyte at 3 months
Leucocyte (/µL)
Change from Baseline Leucocyte at 3 months
Change of Platelet
Time Frame: Change from Baseline Platelet at 3 months
Platelet (thousand/µL)
Change from Baseline Platelet at 3 months
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.
Change from Baseline EQ-5D at 3 months
Change of Basophil
Time Frame: Change from Baseline Basophil at 3 months
Basophil (/µL)
Change from Baseline Basophil at 3 months
Change of Eosinophil
Time Frame: Change from Baseline Eosinophil at 3 months
Eosinophil (/µL)
Change from Baseline Eosinophil at 3 months
Change of Neutrophil
Time Frame: Change from Baseline Neutrophil at 3 months
Neutrophil (/µL)
Change from Baseline Neutrophil at 3 months
Change of Lymphocyte
Time Frame: Change from Baseline Lymphocyte at 3 months
Lymphocyte (/µL)
Change from Baseline Lymphocyte at 3 months
Change of Monocyte
Time Frame: Change from Baseline Monocyte at 3 months
Monocyte (/µL)
Change from Baseline Monocyte at 3 months
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
Change from Baseline C-Reactive Protein at 3 months
Change of D-dimer
Time Frame: Change from Baseline D-dimer at 3 months
Unit of measure : ng/mL
Change from Baseline D-dimer at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Investigators

  • Principal Investigator: Bambang Dwiputra, MD, FIHA, National Cardiovascular Center Harapan Kita Hospital Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

February 20, 2023

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 14, 2021

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Home based Exercise PostCovid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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