Clinical trial NCT04642040: Effectiveness of Pulmonary Rehabilitation Program in Patients With SARS-CoV-2 Pneumonia
Official title: Effectiveness of Pulmonary Rehabilitation Program in Patients With SARS-CoV-2 Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Covid19 Pneumonia
SARS-CoV 2 Pneumonia
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Change in Dyspnea level as measured by modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: 4 weeks
measure: Change in functional capacity as measured by 30-second sit-to-stand test
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in physical activity level as measured by International Physical Activity Questionnaire (IPAQ) -Short Form
timeFrame: 4 weeks
measure: Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale (HADS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Training and Research Hospital
Study officials:
affiliation: Sisli Hamidiye Etfal Training and Research Hospital PMR Clinic
name: Ali Sahillioglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.