Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580808
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Inspiratory Training in Children After Fontan
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Inspiratory Muscle Training in Children After Fontan Surgery
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess physical and respiratory capacity diaphragmatic mobility and quality of life Healthy children and children who have undergone Fontan surgery will participate Some children in the late postoperative period of Fontan surgery will be randomized to a group of inspiratory muscle training that will last for 2 months Children after Fontan surgery will be evaluated twice once at the beginning and again after two months of follow-up
Detailed Description:
This study aims to evaluate physical capacity through cardiopulmonary testing submaximal physical capacity testing by the 6-minute walk test respiratory capacity by spirometry respiratory muscle strength by manovacuometry diaphragmatic mobility by ultrasound quality of life by the AUQEI questionnaire There are three groups a healthy control group a Fontan control group and a Fontan intervention group The intervention will be done by respiratory muscle training using the Power Breath device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None