Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04696198
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2021-01-04
Brief Title:
Thoracic Mobility in Cystic Fibrosis Care
Sponsor:
Göteborg University
Organization:
Göteborg University
Study Overview
Official Title:
Thoracic Mobility in Cystic Fibrosis Care
Status:
COMPLETED
Status Verified Date:
2024-02
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:
Cystic fibrosis CF is an inherited genetic disease of the bodys mucus-producing glands that primarily affects the lungs and gastrointestinal tract There are no studies that have examined anatomical changes the connection between structure and function in the ribcage and the effect of symptom-relieving manual treatment
The purpose of the study is therefore to investigate chest mobility in people with CF
Method The study is conducted in three parts a A retrospective longitudinal part whose purpose is to investigate possible changes in the chest configuration in relation to deterioration of lung volumes in a cohort of CF patients Chest configuration will be measured standardized and blinded on computed tomography CT images and related to results from spirometry examinations
b A prospective consecutive cross-sectional study of the same cohort The aim is to investigate the extent of stiffness and pain that is examined standardized number of pain-free normal moving structures and its relation to objective examination of respiratory movements respiratory muscle strength and spirometry
c A randomized controlled single-blind study aimed at evaluating the effect of manual treatment for pain and reduced mobility in patients with these symptoms The treatments consist of standardized manual therapy with passive joint mobilization without impulse and soft tissue treatment Evaluation will be done via the examination protocol in sub-study b as well as objective measurements of respiratory movements primary variable respiratory muscle strength and spirometry which will be performed by a blinded tester both before and immediately after the intervention control period
Clinical significance When it comes to CF care great medical advances have been made and for Swedish patients the physiotherapeutic active treatment has proven to have very good effects However there are areas where care can be improved The results from our study will provide additional breadth to strategies in CF care
The purpose of the study is therefore to investigate chest mobility in people with CF
Method The study is conducted in three parts a A retrospective longitudinal part whose purpose is to investigate possible changes in the chest configuration in relation to deterioration of lung volumes in a cohort of CF patients Chest configuration will be measured standardized and blinded on computed tomography CT images and related to results from spirometry examinations
b A prospective consecutive cross-sectional study of the same cohort The aim is to investigate the extent of stiffness and pain that is examined standardized number of pain-free normal moving structures and its relation to objective examination of respiratory movements respiratory muscle strength and spirometry
c A randomized controlled single-blind study aimed at evaluating the effect of manual treatment for pain and reduced mobility in patients with these symptoms The treatments consist of standardized manual therapy with passive joint mobilization without impulse and soft tissue treatment Evaluation will be done via the examination protocol in sub-study b as well as objective measurements of respiratory movements primary variable respiratory muscle strength and spirometry which will be performed by a blinded tester both before and immediately after the intervention control period
Clinical significance When it comes to CF care great medical advances have been made and for Swedish patients the physiotherapeutic active treatment has proven to have very good effects However there are areas where care can be improved The results from our study will provide additional breadth to strategies in CF care
Detailed Description:
None
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