Effectiveness of Pulmonary Rehabilitation Program in Patients With SARS-CoV-2 Pneumonia

NCT ID: NCT04642040

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2021-01-31

Brief Summary

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The aim of the study is to investigate the efficacy of pulmonary rehabilitation (PR) program to patients with Sars-CoV-2 pneumonia in the post-acute period on pulmonary functions, exercise capacity and anxiety level.

100 patients diagnosed with Sars-CoV-2 pneumonia will be enrolled in this prospective, interventional study according to inclusion/exclusion criteria. Patients will be evaluated and a personalized PR program will be organized before hospital discharge. After discharge, the pulmonary rehabilitation program will continue in telerehabilitation.

In the telerehabilitation program, exercises will be supervised by a physiotherapist two days a week, and patients will be asked to do the exercises themselves for the other 3 days. Patients will also receive exercise videos for these 3 days.

Patients will be followed for 4 weeks and will be called for final evaluation

Detailed Description

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Conditions

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Covid19 Covid19 Pneumonia SARS-CoV 2 Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pulmonary Rehabilitation

Patients are included in a personalized pulmonary telerehabilitation program consisting of patient education, respiratory and peripheral muscle training, and breathing strategies for 4 weeks. In the telerehabilitation program, exercises will be supervised by a physiotherapist two days a week, and patients will be asked to do the exercises themselves for the other 3 days. Patients will also receive instructional exercise videos for these 3 days.

Group Type EXPERIMENTAL

Pulmonary Rehabilitation

Intervention Type OTHER

Positioning,breathing techniques (diaphragmatic breathing, alternate breathing, and pursed-lip breathing),respiratory muscle exercises, joint ROM exercises, early-mobilization and progressive ambulation, peripheral muscle strengthening exercises

Interventions

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Pulmonary Rehabilitation

Positioning,breathing techniques (diaphragmatic breathing, alternate breathing, and pursed-lip breathing),respiratory muscle exercises, joint ROM exercises, early-mobilization and progressive ambulation, peripheral muscle strengthening exercises

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pneumonia without having severe findings or a need for oxygen support therapy (mild pneumonia) accompanying special conditions (chronic lung / heart disease / diabetes / hypertension / neuromuscular disease history / elderly / immobility etc.)
* Severe pneumonia (A suspicion of fever or respiratory tract infection and having one accompanying finding: respiration rate \>30/min; severe respiratory distress; or SpO2 ≤93% in ambient air.) cases after they get clinically stable (decreased fever, reduced dyspnea, respiratory rate 90%)
* At least 7 days since the diagnosis of SARS-CoV-2 in order to reduce the viral load and the risk of transmission
* Being able to make video calls for telerehabilitation

Exclusion Criteria

* Serious cardiovascular, cerebrovascular, neuromuscular and other systemic diseases that affect physical activity
* Psychiatric illness and cognitive deficit that will affect patient's exercise cooperation
* Pregnancy
* The deterioration in the general condition of the patient, worsening of the lung findings
* Acute respiratory distress syndrome
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Enes Efe Is

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Sahillioglu, MD

Role: PRINCIPAL_INVESTIGATOR

Sisli Hamidiye Etfal Training and Research Hospital PMR Clinic

Locations

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Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Enes Efe Is, MD

Role: CONTACT

Phone: +902123735000

Email: [email protected]

Facility Contacts

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Enes Efe Is, MD

Role: primary

References

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Kurtais Aytur Y, Koseoglu BF, Ozyemisci Taskiran O, Ordu-Gokkaya NK, Unsal Delialioglu S, Sonel Tur B, Sarikaya S, Sirzai H, Tekdemir Tiftik T, Alemdaroglu E, Ayhan FF, Duyur Cakit BD, Genc A, Gundogdu I, Guzel R, Demirbag Karayel D, Bilir Kaya B, Oken O, Ozdemir H, Soyupek F, Tikiz C. Pulmonary rehabilitation principles in SARS-COV-2 infection (COVID-19): A guideline for the acute and subacute rehabilitation. Turk J Phys Med Rehabil. 2020 May 12;66(2):104-120. doi: 10.5606/tftrd.2020.6444. eCollection 2020 Jun.

Reference Type BACKGROUND
PMID: 32760887 (View on PubMed)

Other Identifiers

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2857

Identifier Type: -

Identifier Source: org_study_id