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Clinical Trials/NCT04642040
NCT04642040
Unknown
N/A

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

Sisli Hamidiye Etfal Training and Research Hospital1 site in 1 country100 target enrollmentJune 30, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Covid19
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Enrollment
100
Locations
1
Primary Endpoint
Change in functional capacity as measured by 30-second sit-to-stand test
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 30, 2020
End Date
January 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Enes Efe Is

MD

Sisli Hamidiye Etfal Training and Research Hospital

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

Outcomes

Primary Outcomes

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

Time Frame: 4 weeks

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

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

Time Frame: 4 weeks

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.

Secondary Outcomes

  • 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 Sites (1)

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