Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06330922
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-11
Brief Title:
Muscle-tendon Pathology and Metabolic Dysregulation in CP
Sponsor:
University of Graz
Organization:
University of Graz
Study Overview
Official Title:
Muscle-tendon Pathology Metabolic Dysregulation and Chronic Inflammation in Adolescents and Young Adults With Moderate to Severe Spastic Cerebral Palsy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main aim of this project is to gain knowledge about the muscle-tendon pathology of moderately to severely affected young people with cerebral palsy and their risk for cardiometabolic diseases and chronic inflammation Furthermore it will be investigated whether there are associations between the existing pathophysiology as well as inactivity and muscle function cardiometabolic risk factors and inflammation Moreover the potential of the target group for adaptation of its muscular cardiorespiratory and endocrine system will be investigated
The study parameters will be determined in adolescents and young adults aged 14 to 25 years with moderate to severe spastic cerebral palsy and compared with those of their less severely affected and healthy peers cross-sectional study In addition the more affected individuals will participate in a 12-week training intervention longitudinal study performed with special tricycles ie Frame Runners
To measure the study parameters ultrasound strength tests near-infrared spectroscopy blood analyses and spiroergometry will be used The fitness training will be performed two times a week for 12 weeks with the Frame Runners
The study parameters will be determined in adolescents and young adults aged 14 to 25 years with moderate to severe spastic cerebral palsy and compared with those of their less severely affected and healthy peers cross-sectional study In addition the more affected individuals will participate in a 12-week training intervention longitudinal study performed with special tricycles ie Frame Runners
To measure the study parameters ultrasound strength tests near-infrared spectroscopy blood analyses and spiroergometry will be used The fitness training will be performed two times a week for 12 weeks with the Frame Runners
Detailed Description:
Background Spastic cerebral palsy CP is a neuro-developmental disorder in children Although the initial brain injury is not progressive muscle pathology a leading sign in affected individuals is an on-going process Individuals with CP are less physically active compared to their typically developing TD peers and severely affected individuals are most sedentary Therefore increased muscle wasting decreased muscle function and cardiorespiratory fitness metabolic dysregulation and chronic low-grade inflammation might exist in the latter group However information is scarce and the role of muscle-tendon pathology and physical inactivity remains to be elucidated Finally it is unknown whether their tissues and organs may still adapt to health-inducing stimuli
Objectives The main project aims are 1 to enhance our understanding of spastic muscle-tendon pathology risk of cardiometabolic disease and chronic inflammation likely present in young people with more severe spastic CP and 2 to uncover the relationship of muscle-tendon alterations and physical inactivity on muscle function and metabolism as well as cardiometabolic risk factors and systemic inflammation Moreover the potential for adaptation of their muscular cardiorespiratory and endocrine system will be investigated
Methods A cross-sectional study will be performed to compare severely impaired adolescents and young adults with spastic CP their mildly affected CP and TD peers The former group will further participate in a 12-week cardiorespiratory fitness training with Frame Runners Muscle-tendon properties will be examined using ultrasound and shear wave elastography and muscle function and metabolism with dynamometry and near infrared spectroscopy Blood samples will be analyzed assessing metabolic parameters and pro-inflammatory cytokines Cardiorespiratory fitness will be investigated using the 6-Minute Frame Running Test and gas exchange analysis Physical activity will be evaluated with accelerometers and activity diaries Mental well-being and quality of life will be assessed by use of the CPCHILD questionnaire
Objectives The main project aims are 1 to enhance our understanding of spastic muscle-tendon pathology risk of cardiometabolic disease and chronic inflammation likely present in young people with more severe spastic CP and 2 to uncover the relationship of muscle-tendon alterations and physical inactivity on muscle function and metabolism as well as cardiometabolic risk factors and systemic inflammation Moreover the potential for adaptation of their muscular cardiorespiratory and endocrine system will be investigated
Methods A cross-sectional study will be performed to compare severely impaired adolescents and young adults with spastic CP their mildly affected CP and TD peers The former group will further participate in a 12-week cardiorespiratory fitness training with Frame Runners Muscle-tendon properties will be examined using ultrasound and shear wave elastography and muscle function and metabolism with dynamometry and near infrared spectroscopy Blood samples will be analyzed assessing metabolic parameters and pro-inflammatory cytokines Cardiorespiratory fitness will be investigated using the 6-Minute Frame Running Test and gas exchange analysis Physical activity will be evaluated with accelerometers and activity diaries Mental well-being and quality of life will be assessed by use of the CPCHILD questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None