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Pulmonary Rehabilitation of Patients With a History of COVID-19

Primary Purpose

Covid19

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Sponsored by
University of Rzeszow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV-2, Pulmonary rehabilitation, Quality of life, Body composition, Spirometry, Computed tomography, Morphology, Gasometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Rzeszów / Podkarpackie Center for Lung Diseases in Rzeszów

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pulmonary rehabilitation (intervention)

Arm Description

This group will be covered by pulmonary rehabilitation.

Outcomes

Primary Outcome Measures

Change in the quality of life
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 Outcome Measures

Change in lung volume parameters (spirometry)
Compare the results of: Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC), Total Lung Capacity (TLC), and Residual volume (RV) between baseline, immediately after the end of rehabilitation protocol, and 3 months after the end of the rehabilitation protocol. To obtain the parameters' values, patients will perform tidal breathing and forced inspiration-expiration manoeuvre, and flow-volume loop will be recorded.
Change in respiratory flow parameters (spirometry)
Compare the results of: Peak Expiratory Flow (PEF) and Forced Expiratory Flow at 25-75% of vital capacity (FEF 25-75%) between baseline, immediately after the end of rehabilitation protocol, and 3 months after the end of the rehabilitation protocol. To obtain the parameters' values, patients will perform forced inspiration-expiration manoeuvre, and flow-volume loop will be recorded.
Change in lung diffusing capacity
Compare the results of Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) [ml/min/kPa] between baseline, immediately after the end of rehabilitation protocol, and 3 months after the end of the rehabilitation protocol. To obtain parameter value, patients will perform a full inspiration of a gas mixture containing 0.3% of carbon monoxide; after ten-second breath hold patient exhales and the exhaled breath will be collected and analysed.
Change in Body Mass Index (BMI)
Compare the results of a BMI (kg/m^2) between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol. To calculate BMI, the body height measurement will be performed at baseline using a stadiometer (unit: meter). Body weight will be measure at baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol (unit: kilogram). BMI will be calculated as body weight (kg) divided by height (m) squared.
Change in the body composition (bioelectrical impedance analysis)
Compare the mean content of body fat (%), fat-free mass (%), total body water (%) and muscle mass (%) between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol. Body composition will be obtained using a bioelectrical impedance analysis (BIA) method by foot-to-foot body composition analyzer.
Change in C-reactive protein (CRP) values (blood sample)
Compare the values of C-reactive protein (CRP) [mg/dL] between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol.
Change in D-Dimer values (blood sample)
Compare the values of D-Dimer [ng/mL] between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol.
Change in white blood cell (WBC) values (blood sample)
Compare the values of white blood cell (WBC) [count/mm^3] between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol.
Change in gasometry (blood sample)
Compare the values of pressures of carbon dioxide (pCO2) [mm Hg] and pressures of oxygen (pO2) [mm Hg] between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol.
Change in the percentage of opacity (chest computed tomography)
Compare the percentage of opacity (PO%) between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol.

Full Information

First Posted
February 5, 2021
Last Updated
February 11, 2021
Sponsor
University of Rzeszow
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1. Study Identification

Unique Protocol Identification Number
NCT04751617
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rzeszow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
SARS-CoV-2, Pulmonary rehabilitation, Quality of life, Body composition, Spirometry, Computed tomography, Morphology, Gasometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary rehabilitation (intervention)
Arm Type
Experimental
Arm Description
This group will be covered by pulmonary rehabilitation.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
Pulmonary rehabilitation will include: early mobilization with frequent posture changes and simple exercises in bed taking into account the patient's respiratory tract. Respiratory physiotherapy will also include improving diaphragm function along with training additional respiratory muscles. Active exercises of the upper limbs will be accompanied by gradual muscle strengthening. Aerobic regeneration will be carried out by walking along the hospital corridor, stationary bike and climbing stairs. Body balance therapy in closed systems in front of the mirror will also be included. After kinesiotherapy, the session will end with a vibration massage and relaxation of the whole body. Motivational breathing training will be used every 2 hours, 7 days a week, performed independently by the patient in the ward room. The physiotherapy process will be carried out 6 times a week and lasts 30-45 minutes a day. The duration of rehabilitation depends on the patient's condition: from 7 to 14 days.
Primary Outcome Measure Information:
Title
Change in the quality of life
Description
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.
Time Frame
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Secondary Outcome Measure Information:
Title
Change in lung volume parameters (spirometry)
Description
Compare the results of: Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC), Total Lung Capacity (TLC), and Residual volume (RV) between baseline, immediately after the end of rehabilitation protocol, and 3 months after the end of the rehabilitation protocol. To obtain the parameters' values, patients will perform tidal breathing and forced inspiration-expiration manoeuvre, and flow-volume loop will be recorded.
Time Frame
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Title
Change in respiratory flow parameters (spirometry)
Description
Compare the results of: Peak Expiratory Flow (PEF) and Forced Expiratory Flow at 25-75% of vital capacity (FEF 25-75%) between baseline, immediately after the end of rehabilitation protocol, and 3 months after the end of the rehabilitation protocol. To obtain the parameters' values, patients will perform forced inspiration-expiration manoeuvre, and flow-volume loop will be recorded.
Time Frame
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Title
Change in lung diffusing capacity
Description
Compare the results of Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) [ml/min/kPa] between baseline, immediately after the end of rehabilitation protocol, and 3 months after the end of the rehabilitation protocol. To obtain parameter value, patients will perform a full inspiration of a gas mixture containing 0.3% of carbon monoxide; after ten-second breath hold patient exhales and the exhaled breath will be collected and analysed.
Time Frame
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Title
Change in Body Mass Index (BMI)
Description
Compare the results of a BMI (kg/m^2) between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol. To calculate BMI, the body height measurement will be performed at baseline using a stadiometer (unit: meter). Body weight will be measure at baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol (unit: kilogram). BMI will be calculated as body weight (kg) divided by height (m) squared.
Time Frame
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Title
Change in the body composition (bioelectrical impedance analysis)
Description
Compare the mean content of body fat (%), fat-free mass (%), total body water (%) and muscle mass (%) between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol. Body composition will be obtained using a bioelectrical impedance analysis (BIA) method by foot-to-foot body composition analyzer.
Time Frame
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Title
Change in C-reactive protein (CRP) values (blood sample)
Description
Compare the values of C-reactive protein (CRP) [mg/dL] between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol.
Time Frame
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Title
Change in D-Dimer values (blood sample)
Description
Compare the values of D-Dimer [ng/mL] between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol.
Time Frame
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Title
Change in white blood cell (WBC) values (blood sample)
Description
Compare the values of white blood cell (WBC) [count/mm^3] between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol.
Time Frame
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Title
Change in gasometry (blood sample)
Description
Compare the values of pressures of carbon dioxide (pCO2) [mm Hg] and pressures of oxygen (pO2) [mm Hg] between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol.
Time Frame
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Title
Change in the percentage of opacity (chest computed tomography)
Description
Compare the percentage of opacity (PO%) between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol.
Time Frame
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Rzeszów / Podkarpackie Center for Lung Diseases in Rzeszów
City
Rzeszów
ZIP/Postal Code
35-959
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Pulmonary Rehabilitation of Patients With a History of COVID-19

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