Skip to main content
Clinical Trials/NCT04751617
NCT04751617
Unknown
Not Applicable

Impact of Pulmonary Rehabilitation on Quality of Life, Body Composition and Respiratory Function of Patients With a History of COVID-19

University of Rzeszow1 site in 1 country60 target enrollmentJanuary 1, 2021
ConditionsCovid19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
University of Rzeszow
Enrollment
60
Locations
1
Primary Endpoint
Change in the quality of life
Last Updated
5 years ago

Overview

Brief Summary

This study will determine the impact of pulmonary rehabilitation on quality of life, body composition and respiratory function in patients with a history of COVID-19.

Detailed Description

In December 2019, a novel coronavirus, SARS-CoV-2, appeared, causing a wide range of symptoms, mainly respiratory infection. In March 2020, the World Health Organization (WHO) declared Coronavirus Disease 2019 (COVID-19) a pandemic. COVID-19 has spread rapidly over several months, affecting patients across all age groups and geographic areas. The disease has a diverse course; patients may range from asymptomatic to those with respiratory failure, complicated by acute respiratory distress syndrome. The main objective of this study is to assess the impact of pulmonary rehabilitation on quality of life, body composition and respiratory function in patients with a history of COVID-19. The patients after COVID-19 will be included in the pulmonary rehabilitation protocol. The duration of rehabilitation will depend on the patient's condition: from 7 to 14 days. Measurements: * quality of life (WHOQoL-BREF) * body composition (bioelectrical impedance analysis, BC-420 MA, Tanita) * weight, height and BMI * spirometry (Spirometr PNEUMO, abcMED) * diffusion lung capacity for carbon monoxide (LUNGTEST 1000) * morphology (CRP, D-Dimer, WBC) and gasometry (pCO2, pO2) * chest computed tomography (CT). These parameters will be recorded before the first day of rehabilitation (baseline), after completion of rehabilitation protocol, and three months after completion the rehabilitation protocol. A change in evaluated parameters will be assessed. This will be a prospective, interventional, non-randomized study. All patients will be enrolled by Podkarpackie Center for Lung Diseases in Rzeszów.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
March 31, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Rzeszow
Responsible Party
Principal Investigator
Principal Investigator

Justyna Wyszyńska

Principal Investigator

University of Rzeszow

Eligibility Criteria

Inclusion Criteria

  • Male and female patients treated in Provincial Clinical Hospital No. 1 in Rzeszów/ Podkarpackie Center for Lung Diseases in Rzeszów,
  • Patients with a history of COVID-19,
  • Having obtained written informed consent (signed and dated) to participate in the study,
  • Age at enrollment ≥ 18 years of age,
  • No contraindications to pulmonary rehabilitation,
  • No contraindications for body composition testing (bioelectrical impedance analysis).

Exclusion Criteria

  • Refusal to participate in the study,
  • Patients with any acute disease in the last 3 months before baseline,
  • Patients currently enrolled in any clinical trial,
  • Currently infected patients with COVID-19.

Outcomes

Primary Outcomes

Change in the quality of life

Time Frame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion

Comparison of the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire mean between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol. The questionnaire consists of 26 questions. Answers are awarded a score in a five-point scale (1-5). Answer scores are calculated according to the WHOQOL-BREF algorithm in the range of 0-100 points. Higher score corresponds to higher quality of life.

Secondary Outcomes

  • Change in respiratory flow parameters (spirometry)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
  • Change in gasometry (blood sample)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
  • Change in lung diffusing capacity(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
  • Change in Body Mass Index (BMI)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
  • Change in the body composition (bioelectrical impedance analysis)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
  • Change in C-reactive protein (CRP) values (blood sample)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
  • Change in white blood cell (WBC) values (blood sample)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
  • Change in lung volume parameters (spirometry)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
  • Change in D-Dimer values (blood sample)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
  • Change in the percentage of opacity (chest computed tomography)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)

Study Sites (1)

Loading locations...

Similar Trials