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

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

Study Overview

• Status: Unknown
• Conditions: Covid19; Covid19 Pneumonia; SARS-CoV 2 Pneumonia
• Intervention / Treatment: Other: Pulmonary Rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34371
    • Recruiting
    • Sisli Hamidiye Etfal Training and Research Hospital
    • Contact: Enes Efe Is, MD; Phone Number: +902123735000; Email: enefeis@gmail.com
    • Principal Investigator: Ali Sahillioglu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity level as measured by International Physical Activity Questionnaire (IPAQ) -Short Form	IPAQ-Short Form is used to measure level of physical activity.It consists of 7 questions that provide information about time spent on walking, moderate to vigorous physical activities, and time spent sitting. The energy required for the activities was calculated by the MET-minute/week score. Standard MET values for these activities are: Walking = 3,3 METS; Moderate Physical Activity = 4,0 METS; Vigorous Physical Activity = 8.0 METS; Sitting = 1,5 METS	4 weeks
Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale (HADS)	HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression.The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety.	4 weeks

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Principal Investigator: Ali Sahillioglu, MD, Sisli Hamidiye Etfal Training and Research Hospital PMR Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: November 21, 2020
• First Submitted That Met QC Criteria: November 21, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 21, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: 2857

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No