COVID-19 PneumoniaNCT05063799
Pulmonary Rehabilitation After Pregnancy in COVID-19 Infection: A Case Report
A study testing pulmonary rehabilitation in people with COVID-19 Pneumonia and Pulmonary Rehabilitation, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The 33-month pregnant patient was followed in the gynecology service with the complaint of shortness of breath after receiving the covid positive diagnosis and was transferred to the intensive care unit due to acute respiratory failure. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pneumonia, Pulmonary Rehabilitation, Pregnancy
- What is being tested?
- pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2021to 15 Sep 2022
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -pregnant and covid patient
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The 33-month pregnant patient was followed in the gynecology service with the complaint of shortness of breath after receiving the covid positive diagnosis and was transferred to the intensive care unit due to acute respiratory failure. She was intubated in the intensive care unit and the baby was taken by cesarean section. Pulmonary rehabilitation steps to be applied to the patient with long-term intensive care hospitalization will be examined.
Read the detailed description
After the patient was admitted to the chest diseases service, pulmonary rehabilitation was started. The patient was evaluated before starting pulmonary rehabilitation.
Evaluation parameters; vital signs, shortness of breath, oxygen support, grip force and pinchmeter, fatigue, anxiety and depression, cognitive functions. The pulmonary rehabilitation program will be implemented every day during the hospitalization. The pulmonary rehabilitation program will consist of breathing exercises, strengthening training of upper and lower extremity, exercises in bed, mobilization and reducing oxygen support. The patient will be re-evaluated before discharge.Pulmonary rehabilitation after discharge will continue 2-3 days a week.The patient will be re-evaluated at the 3rd, 6th, 9th and 12th months.
- Conditions
- COVID-19 Pneumonia, Pulmonary Rehabilitation, Pregnancy
- Being tested
- pulmonary rehabilitation
- Keywords
- COVID-19, pulmonary rehabilitation, pregnant
- 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 rehabilitationOther
pulmonary rehabilitation programs
| Study group | Role | What they receive |
|---|---|---|
| a case included pulmonary rehabilitation program | Experimental | Not described Receives: Other: pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
finger muscle power
Peripheral muscle strength will be measured with a pinchmeter
Measured: 15 second
grip strength
Peripheral muscle strength will be measured with dynamometer
Measured: 15 second
Secondary outcomes (3)
Assessment of cognitive
Cognitive will be assessed by Montreal Cognitive Assessment. MoCA Test; a score of 19 to 25 indicates mild cognitive impairment. Scores of between 11 and 21 suggest mild Alzheimer's disease. There is some overlap between this type of dementia and mild cognitive impairment, reflecting the difficulty in using a single test to make this type of diagnosis
Measured: 10 minutes
Assessment of anxiety and depression
Anxiety and depression will be assessed by Hospital Anxiety and Depression Scale.The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Measured: 10 minutes
Assessment of fatigue
Fatigue will be assessed by Functional Assessment of Chronic Illness Therapy. The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start10 Oct 2021
- Primary completion30 Oct 2021
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Halime Sinem Barutçu, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063799
- Sponsor's protocol ID
- DrLutfiKirdarCH
- Status last verified
- Nov 2022
- First submitted
- 28 Sep 2021
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation After Pregnancy in COVID-19 Infection: A Case Report
- ClinicalTrials.gov ID
- NCT05063799
- Acronym / sponsor ID
- DrLutfiKirdarCH
- Conditions
- COVID-19 Pneumonia, Pulmonary Rehabilitation, Pregnancy
- Keywords
- COVID-19, pulmonary rehabilitation, pregnant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 1 Oct 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.
The 33-month pregnant patient was followed in the gynecology service with the complaint of shortness of breath after receiving the covid positive diagnosis and was transferred to the intensive care unit due to acute respiratory failure. She was intubated in the intensive care unit and the baby was taken by cesarean section. Pulmonary rehabilitation steps to be applied to the patient with long-term intensive care hospitalization will be examined.
Detailed description
After the patient was admitted to the chest diseases service, pulmonary rehabilitation was started. The patient was evaluated before starting pulmonary rehabilitation.
Evaluation parameters; vital signs, shortness of breath, oxygen support, grip force and pinchmeter, fatigue, anxiety and depression, cognitive functions. The pulmonary rehabilitation program will be implemented every day during the hospitalization. The pulmonary rehabilitation program will consist of breathing exercises, strengthening training of upper and lower extremity, exercises in bed, mobilization and reducing oxygen support. The patient will be re-evaluated before discharge.Pulmonary rehabilitation after discharge will continue 2-3 days a week.The patient will be re-evaluated at the 3rd, 6th, 9th and 12th months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a case included pulmonary rehabilitation program | Experimental | Other: pulmonary rehabilitation |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -pregnant and covid patient
Key exclusion criteria (0 listed)
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 programs | Other | a case included pulmonary rehabilitation program |
Primary outcome
finger muscle power
Time frame: 15 second
Peripheral muscle strength will be measured with a pinchmeter
grip strength
Time frame: 15 second
Peripheral muscle strength will be measured with dynamometer
3 secondary outcomes
Assessment of cognitive
Time frame: 10 minutes
Assessment of anxiety and depression
Time frame: 10 minutes
Assessment of fatigue
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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 COVID-19 Pneumonia and Pulmonary Rehabilitation, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 2 Dec 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
finger muscle power (time frame: 15 second). The study lists 2 primary outcomes in all. 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 2 Dec 2022.