Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559865
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function and Symptom Severity in Youth Post-concussion a Pilot Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-09
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:
Breathe
Brief Summary:
The goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the sub-acute period after concussion and to document the autonomic function and symptom severity post-concussion symptoms anxiety sleep before and after administration of the intervention
Participants will
will be instructed to perform a daily 10-minutes daily paced breathing home-exercise program and to document the daily exercises performed within a performance log or receive usual care from a concussion follow-up program
A weekly phone meeting will be performed with the participants to review exercise providing specific instructions and making any necessary adjustments
All participants intervention and control group will undergo a second assessment after four weeks following completion of the intervention program During the second assessment information regarding the intervention feasibility time to return to school return to sport and clear from medication will be collected as well
Participants will
will be instructed to perform a daily 10-minutes daily paced breathing home-exercise program and to document the daily exercises performed within a performance log or receive usual care from a concussion follow-up program
A weekly phone meeting will be performed with the participants to review exercise providing specific instructions and making any necessary adjustments
All participants intervention and control group will undergo a second assessment after four weeks following completion of the intervention program During the second assessment information regarding the intervention feasibility time to return to school return to sport and clear from medication will be collected as well
Detailed Description:
None
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