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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05063799
Other study ID # DrLutfiKirdarCH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2021
Est. completion date September 15, 2022

Study information

Verified date November 2022
Source Dr. Lutfi Kirdar Kartal Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date September 15, 2022
Est. primary completion date October 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: -pregnant and covid patient Exclusion Criteria:

Study Design


Intervention

Other:
pulmonary rehabilitation
pulmonary rehabilitation programs

Locations

Country Name City State
Turkey Halime Sinem Barutcu Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary finger muscle power Peripheral muscle strength will be measured with a pinchmeter 15 second
Primary grip strength Peripheral muscle strength will be measured with dynamometer 15 second
Secondary 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 10 minutes
Secondary 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. 10 minutes
Secondary 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) 10 minutes
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