Clinical trial NCT04751617: Pulmonary Rehabilitation of Patients With a History of COVID-19
Official title: Impact of Pulmonary Rehabilitation on Quality of Life, Body Composition and Respiratory Function of Patients With a History of COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: SARS-CoV-2
Pulmonary rehabilitation
Quality of life
Body composition
Spirometry
Computed tomography
Morphology
Gasometry
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the quality of life
timeFrame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Secondary outcomes:
measure: Change in lung volume parameters (spirometry)
timeFrame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
measure: Change in respiratory flow parameters (spirometry)
timeFrame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
measure: Change in lung diffusing capacity
timeFrame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
measure: Change in Body Mass Index (BMI)
timeFrame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
measure: Change in the body composition (bioelectrical impedance analysis)
timeFrame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
measure: Change in C-reactive protein (CRP) values (blood sample)
timeFrame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
measure: Change in D-Dimer values (blood sample)
timeFrame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
measure: Change in white blood cell (WBC) values (blood sample)
timeFrame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
measure: Change in gasometry (blood sample)
timeFrame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
measure: Change in the percentage of opacity (chest computed tomography)
timeFrame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: University of Rzeszów / Podkarpackie Center for Lung Diseases in Rzeszów
Study officials:
References: