Covid19NCT04751617
Pulmonary Rehabilitation of Patients With a History of COVID-19
A study testing Pulmonary rehabilitation in people with Covid19, run by University of Rzeszow at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Pulmonary rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2021to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
University of Rzeszów / Podkarpackie Center for Lung Diseases in Rzeszów
Rzeszów, 35-959
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Pulmonary rehabilitation
- Keywords
- SARS-CoV-2, Pulmonary rehabilitation, Quality of life, Body composition, Spirometry, Computed tomography, Morphology, Gasometry
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation (intervention) | Experimental | This group will be covered by pulmonary rehabilitation. Receives: Procedure: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Secondary outcomes (10)
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.
Measured: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
Measured: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
Measured: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
Measured: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
Measured: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
Measured: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
Measured: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
Measured: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
Measured: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
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.
Measured: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Jan 2021
- Primary completion31 Jan 2021
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justyna Wyszyńska, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751617
- Sponsor's protocol ID
- Rehabilitation after COVID-19
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pulmonary Rehabilitation on Quality of Life, Body Composition and Respiratory Function of Patients With a History of COVID-19
- ClinicalTrials.gov ID
- NCT04751617
- Acronym / sponsor ID
- Rehabilitation after COVID-19
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, Pulmonary rehabilitation, Quality of life, Body composition, Spirometry, Computed tomography, Morphology, Gasometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation (intervention) | Experimental | Procedure: Pulmonary rehabilitationThis group will be covered by pulmonary rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitationPulmonary 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. | Procedure or surgery | Pulmonary rehabilitation (intervention) |
Primary outcome
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.
10 secondary outcomes
Change in lung volume parameters (spirometry)
Time frame: 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
Change in lung diffusing capacity
Time frame: 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
Change in the body composition (bioelectrical impedance analysis)
Time frame: 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
Change in D-Dimer values (blood sample)
Time frame: 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
Change in gasometry (blood sample)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with Covid19, run by University of Rzeszow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the quality of life (time frame: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.