Pulmonary Rehabilitation After Pregnancy in COVID-19 Infection: A Case Report
Primary Purpose
COVID-19 Pneumonia, Pulmonary Rehabilitation, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring COVID-19, pulmonary rehabilitation, pregnant
Eligibility Criteria
Inclusion Criteria:
-pregnant and covid patient
Exclusion Criteria:
Sites / Locations
- Halime Sinem Barutcu
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
a case included pulmonary rehabilitation program
Arm Description
Outcomes
Primary Outcome Measures
finger muscle power
Peripheral muscle strength will be measured with a pinchmeter
grip strength
Peripheral muscle strength will be measured with dynamometer
Secondary Outcome Measures
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
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.
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)
Full Information
NCT ID
NCT05063799
First Posted
September 28, 2021
Last Updated
November 30, 2022
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05063799
Brief Title
Pulmonary Rehabilitation After Pregnancy in COVID-19 Infection: A Case Report
Official Title
Pulmonary Rehabilitation After Pregnancy in COVID-19 Infection: A Case Report
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 10, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
September 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia, Pulmonary Rehabilitation, Pregnancy
Keywords
COVID-19, pulmonary rehabilitation, pregnant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
a case included pulmonary rehabilitation program
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
pulmonary rehabilitation
Intervention Description
pulmonary rehabilitation programs
Primary Outcome Measure Information:
Title
finger muscle power
Description
Peripheral muscle strength will be measured with a pinchmeter
Time Frame
15 second
Title
grip strength
Description
Peripheral muscle strength will be measured with dynamometer
Time Frame
15 second
Secondary Outcome Measure Information:
Title
Assessment of cognitive
Description
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
Time Frame
10 minutes
Title
Assessment of anxiety and depression
Description
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.
Time Frame
10 minutes
Title
Assessment of fatigue
Description
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)
Time Frame
10 minutes
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-pregnant and covid patient
Exclusion Criteria:
Facility Information:
Facility Name
Halime Sinem Barutcu
City
İstanbul
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pulmonary Rehabilitation After Pregnancy in COVID-19 Infection: A Case Report
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