Pulmonary Rehabilitation of Patients With a History of COVID-19

February 11, 2021 updated by: Justyna Wyszyńska, University of Rzeszow

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Rzeszów, Poland, 35-959
        • University of Rzeszów / Podkarpackie Center for Lung Diseases in Rzeszów

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pulmonary rehabilitation (intervention)
This group will be covered by pulmonary rehabilitation.
Procedure: Pulmonary rehabilitation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in lung volume parameters (spirometry)
Time Frame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion

Compare the results of:

  1. Forced Expiratory Volume in one second (FEV1),
  2. Forced Vital Capacity (FVC),
  3. Total Lung Capacity (TLC), and
  4. 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.
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Change in respiratory flow parameters (spirometry)
Time Frame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion

Compare the results of:

  1. Peak Expiratory Flow (PEF) and
  2. 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.
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Change in lung diffusing capacity
Time Frame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Change in Body Mass Index (BMI)
Time Frame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion

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.
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Change in the body composition (bioelectrical impedance analysis)
Time Frame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Change in C-reactive protein (CRP) values (blood sample)
Time Frame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Change in D-Dimer values (blood sample)
Time Frame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Change in white blood cell (WBC) values (blood sample)
Time Frame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Change in gasometry (blood sample)
Time Frame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Change in the percentage of opacity (chest computed tomography)
Time Frame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rzeszow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Rehabilitation after COVID-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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