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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04642040
• Other study ID #: 2857
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: January 2021

Study information

• Verified date: November 2020
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: Enes Efe Is, MD
• Phone: +902123735000
• Email: enefeis[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Covid19 Pneumonia
• Pneumonia
• SARS-CoV 2 Pneumonia

Intervention

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

Locations

Country	Name	City	State
Turkey	Sisli Hamidiye Etfal Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Kurtais Aytür Y, Köseoglu BF, Özyemisçi Taskiran Ö, Ordu-Gökkaya NK, Ünsal Delialioglu S, Sonel Tur B, Sarikaya S, Sirzai H, Tekdemir Tiftik T, Alemdaroglu E, Ayhan FF, Duyur Çakit BD, Genç A, Gündogdu I, Güzel R, Demirbag Karayel D, Bilir Kaya B, Öken Ö, Özdemir 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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