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Covid19NCT05077943

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

A study testing Breathing and chest mobilization exercises and Second phase cardiac rehabilitation in people with Covid19 and Breathing Exercise, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Breathing and chest mobilization exercises and Second phase cardiac rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteIndonesia
Study dates
1 Sep 2021to 20 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who got infected by Covid-19 in 3 months before recruitment and suffering cardiovascular disease
  • Able to communicate and operate Youtube and Zoom.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • National Cardiovascular Center Harapan Kita Hospital Indonesia

    Jakarta, 11420

Other trials in Indonesia

About this study

Official title: 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.

Read the 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.

Being tested
Breathing and chest mobilization exercises, Second phase cardiac rehabilitation
Medical subject headings
COVID-19, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breathing and chest mobilization exercisesBehavioural

    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 rehabilitationBehavioural

    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.

Study groups in NCT05077943
Study groupRoleWhat they receive
No Breathing ExerciseActive comparatorPatients will do the second phase of cardiac rehabilitation for minimum 5 times per week, 30 minutes each time, in 3 months without being supervised
Receives: Behavioral: Second phase cardiac rehabilitation
With Breathing ExerciseExperimentalPatients 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.
Receives: Behavioral: Breathing and chest mobilization exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Peak Cough Flow (PC)

    to define the functional capacity. Unit of measure : L/min.

    Measured: Change from Baseline Peak Cough Flow (PC) at 3 months

  2. Change of Peak Flow Rate (PFR)

    to define the functional capacity. Unit of measure : L/min.

    Measured: Change from Baseline Peak Flow Rate (PFR) at 3 months

  3. Change of Cardiac Exercise Test

    Patients walk on treadmill. Unit of measure : minutes, METs (Metabolic Equivalent of Task)

    Measured: Change from Baseline Cardiac Exercise Test at 3 months

  4. 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

    Measured: Change from Baseline 6-minutes walking test at 3 months

Secondary outcomes (17)

  1. Change of Hemoglobin

    Hemoglobin (g/dL)

    Measured: Change from Baseline Hemoglobin at 3 months

  2. Change of Hematocrit

    Hematocrit (%)

    Measured: Change from Baseline Hematocrit at 3 months

  3. Change of Erythrocyte

    Erythrocyte (million/µL)

    Measured: Change from Baseline Erythrocyte at 3 months

  4. Change of Mean Corpuscular Volume

    Mean Corpuscular Volume (fL)

    Measured: Change from Baseline Mean Corpuscular Volume at 3 months

  5. Change of Mean Corpuscular Hemoglobin

    Mean Corpuscular Hemoglobin (pg)

    Measured: Change from Baseline Mean Corpuscular Hemoglobin at 3 months

  6. Change of Mean Corpuscular Hemoglobin Concentration

    Mean Corpuscular Hemoglobin Concentration (%)

    Measured: Change from Baseline Mean Corpuscular Hemoglobin Concentration at 3 months

  7. Change of Red Cell Distribution Width

    Red Cell Distribution Width (%)

    Measured: Change from Baseline Red Cell Distribution Width at 3 months

  8. Change of Leucocyte

    Leucocyte (/µL)

    Measured: Change from Baseline Leucocyte at 3 months

  9. Change of Platelet

    Platelet (thousand/µL)

    Measured: Change from Baseline Platelet at 3 months

  10. 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.

    Measured: Change from Baseline EQ-5D at 3 months

  11. Change of Basophil

    Basophil (/µL)

    Measured: Change from Baseline Basophil at 3 months

  12. Change of Eosinophil

    Eosinophil (/µL)

    Measured: Change from Baseline Eosinophil at 3 months

  13. Change of Neutrophil

    Neutrophil (/µL)

    Measured: Change from Baseline Neutrophil at 3 months

  14. Change of Lymphocyte

    Lymphocyte (/µL)

    Measured: Change from Baseline Lymphocyte at 3 months

  15. Change of Monocyte

    Monocyte (/µL)

    Measured: Change from Baseline Monocyte at 3 months

  16. Change of C-Reactive Protein

    to determine infection markers. Unit of measure : mg/L

    Measured: Change from Baseline C-Reactive Protein at 3 months

  17. Change of D-dimer

    Unit of measure : ng/mL

    Measured: Change from Baseline D-dimer at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2021
  2. Study start1 Sep 2021
  3. Primary completion31 Jan 2023
  4. Study completion20 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05077943
Sponsor's protocol ID
Home based Exercise PostCovid
Status last verified
Feb 2023
First submitted
29 Sep 2021
Last updated
23 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • 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.

    PubMed 32729939

  • 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.

    PubMed 32859681

  • 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.

    PubMed 32793618

  • 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.

    PubMed 32462177

  • 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.

    PubMed 33419740

  • 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.

    PubMed 33512598

  • 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.

    PubMed 32475821

  • 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

  • Dwiputra B, Ambari AM, Triangto K, Supriami K, Kesuma TW, Zuhdi N, Phowira J, Radi B. The home-based breathing and chest mobility exercise improves cardiorespiratory functional capacity in long COVID with cardiovascular comorbidities: a randomized study. BMC Cardiovasc Disord. 2024 Oct 18;24(1):574. doi: 10.1186/s12872-024-04196-0.

    PubMed 39425012

Questions about this trial

What is this clinical trial studying?

A study testing Breathing and chest mobilization exercises and Second phase cardiac rehabilitation in people with Covid19 and Breathing Exercise, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Peak Cough Flow (PC) (time frame: Change from Baseline Peak Cough Flow (PC) at 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05077943, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.

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