Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099424
Status:
COMPLETED
Last Update Posted:
2008-06-05
First Post:
2004-12-13
Brief Title:
Exercise Training in Sarcoidosis EXTRAS Study
Sponsor:
University Hospital Gasthuisberg
Organization:
University Hospital Gasthuisberg
Study Overview
Official Title:
EXercise TRAining in Sarcoidosis EXTRAS Study A Prospective Randomized Controlled Crossover Trial
Status:
COMPLETED
Status Verified Date:
2008-06
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:
Exercise intolerance and reduced health status have been found in patients with sarcoidosis and has been related to skeletal muscle weakness The present researchers reason that skeletal muscle weakness is at least in part related to physical inactivity and therefore partially reversible following a structured exercise training program Nevertheless the effects of exercise training have never been studied in patients with sarcoidosis Therefore the present study is undertaken to explore the effects of exercise training in patients with sarcoidosis A priori the following hypotheses are formulated
A 12-week exercise training program improves health status quality of life and exercise capacity in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention
A 12-week exercise training program improves skeletal muscle function and reduces complaints of anxiety and depression in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention
A 12-week exercise training program reduces circulating levels of inflammatory markers in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention
A 12-week exercise training program improves health status quality of life and exercise capacity in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention
A 12-week exercise training program improves skeletal muscle function and reduces complaints of anxiety and depression in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention
A 12-week exercise training program reduces circulating levels of inflammatory markers in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention
Detailed Description:
The EXTRAS study is a prospective randomized controlled 24-week crossover clinical trial in which the participants are randomly assigned to receive 12 weeks of dynamic resistance and whole-body endurance exercises followed by 12 weeks without intervention or vice versa Consenting participants will be assessed at baseline before randomization week 0 and at weeks 12 and 24
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