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

NCT04642040 | Unknown

• 1 other identifier: 2857
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19; Covid19 Pneumonia; SARS-CoV 2 Pneumonia

Outcome Measures

Primary Outcomes (2)

• Change in Dyspnea level as measured by modified Medical Research Council (mMRC) Dyspnea Scale

  The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4. 0: no breathlessness except on strenuous exercise; 4: too breathless to leave the house, or breathless when dressing or undressing.

  4 weeks

• Change in functional capacity as measured by 30-second sit-to-stand test

  30 sec- STS determines lower extremity strength and physical fitness in older adults. The number of repetitions is recorded.

  4 weeks

Secondary Outcomes (2)

• Change in physical activity level as measured by International Physical Activity Questionnaire (IPAQ) -Short Form

  4 weeks

• Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale (HADS)

  4 weeks

Study Arms (1)

Pulmonary Rehabilitation

EXPERIMENTAL

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.

Other: Pulmonary Rehabilitation

Interventions

Pulmonary Rehabilitation 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

Pulmonary Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 32760887 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ali Sahillioglu, MD

  Sisli Hamidiye Etfal Training and Research Hospital PMR Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enes Efe Is, MD

CONTACT

+902123735000; enefeis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 21, 2020
• First Posted: November 24, 2020
• Study Start: June 30, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)