Pulmonary Rehabilitation After Pregnancy in COVID-19 Infe... | NCT05063799

Studies
Pulmonary Rehabilitation After Pregnancy in COVID-19 Infection: A Case Report

NCT05063799

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Status

Completed

Last Update Posted

Dec 2, 2022Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

COVID-19 Pneumonia
Pulmonary Rehabilitation
Pregnancy

Interventions

pulmonary rehabilitation

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2021Actual

Primary Completion Date

Oct 30, 2021Actual

Completion Date

Sep 15, 2022Actual

First Submitted Date

Sep 28, 2021

First Submission Date that Met QC Criteria

Sep 30, 2021

First Posted Date

Oct 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2022

Last Update Posted Date

Dec 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Halime Sinem Barutçu, Physical Therapist, Dr. Lutfi Kirdar Kartal Training and Research HospitalPrincipal Investigator

Lead Sponsor

Dr. Lutfi Kirdar Kartal Training and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
a case included pulmonary rehabilitation program	Experimental		Other: pulmonary rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pulmonary rehabilitation	Other	pulmonary rehabilitation programs	a case included pulmonary rehabilitation program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
finger muscle power	Peripheral muscle strength will be measured with a pinchmeter	15 second
grip strength	Peripheral muscle strength will be measured with dynamometer	15 second

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-pregnant and covid patient

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Halime Sinem Barutcu		Istanbul		34000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided