NCT05077943

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

September 29, 2021

Last Update Submit

February 21, 2023

Conditions

Covid19Breathing ExerciseCardiovascular Diseases

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (17)

  • Change of Hemoglobin

    Change from Baseline Hemoglobin at 3 months

  • Change of Hematocrit

    Change from Baseline Hematocrit at 3 months

  • Change of Erythrocyte

    Change from Baseline Erythrocyte at 3 months

  • Change of Mean Corpuscular Volume

    Change from Baseline Mean Corpuscular Volume at 3 months

  • Change of Mean Corpuscular Hemoglobin

    Change from Baseline Mean Corpuscular Hemoglobin at 3 months

  • +12 more secondary outcomes

Study Arms (2)

No Breathing Exercise

ACTIVE COMPARATOR

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

With Breathing Exercise

EXPERIMENTAL

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

Interventions

Breathing and chest mobilization exercisesBEHAVIORAL

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.

With Breathing Exercise
Second phase cardiac rehabilitationBEHAVIORAL

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.

No Breathing Exercise

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cardiovascular Center Harapan Kita Hospital Indonesia

Jakarta, 11420, Indonesia

Location

Related Publications (10)

  • 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

    BACKGROUND

  • 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.

    PMID: 32729939BACKGROUND

  • 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.

    PMID: 32859681BACKGROUND

  • 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.

    PMID: 32793618BACKGROUND

  • 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.

    PMID: 32462177BACKGROUND

  • 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.

    PMID: 33419740BACKGROUND

  • 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.

    PMID: 33512598BACKGROUND

  • 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.

    PMID: 32475821BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 39425012DERIVED

MeSH Terms

Conditions

COVID-19Cardiovascular Diseases

Interventions

Respiration

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Bambang Dwiputra, MD, FIHA

    National Cardiovascular Center Harapan Kita Hospital Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Cardiologist, Principal Investigator

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 14, 2021

Study Start

September 1, 2021

Primary Completion

January 31, 2023

Study Completion

February 20, 2023

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)