Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258492
Status:
UNKNOWN
Last Update Posted:
2007-01-26
First Post:
2005-11-22
Brief Title:
Restless Legs Syndrome Exercise Intervention
Sponsor:
Northeastern Ohio Universities College of Medicine
Organization:
Northeastern Ohio Universities College of Medicine
Study Overview
Official Title:
The Prevalence and Outcomes of Restless Legs Syndrome Among Veterans - Exercise Intervention
Status:
UNKNOWN
Status Verified Date:
2006-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
A pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep quality among patients with Restless Legs Syndrome RLS We the researchers at Northeastern Ohio Universities College of Medicine hypothesize that relative to a control group RLS sufferers who participate in an aerobic exercise intervention will demonstrate
1 reduced RLS symptoms
2 improved sleep quality
3 reduced daytime sleepiness
1 reduced RLS symptoms
2 improved sleep quality
3 reduced daytime sleepiness
Detailed Description:
We will implement an exercise intervention among persons who suffer from RLS
Study members will be Veterans over the age of 40 who have been identified as RLS cases as part of our larger study of The Prevalence and Outcomes of Restless Legs Syndrome among Veterans We will use a cross-over design in which Veterans will be randomly assigned to the exercise intervention or control Each arm of the study will be 3 months duration
The protocol for the intervention will consist of twice weekly supervised exercise sessions The goal for exercise participants will be to engage in continuous aerobic exercise for 45 minutes at an intensity of approximately 60 of VO2max The control will be weekly support group meetings
Outcomes will be measured using standardized sleep scales actigraphy and daily sleep and exercise logs
Study members will be Veterans over the age of 40 who have been identified as RLS cases as part of our larger study of The Prevalence and Outcomes of Restless Legs Syndrome among Veterans We will use a cross-over design in which Veterans will be randomly assigned to the exercise intervention or control Each arm of the study will be 3 months duration
The protocol for the intervention will consist of twice weekly supervised exercise sessions The goal for exercise participants will be to engage in continuous aerobic exercise for 45 minutes at an intensity of approximately 60 of VO2max The control will be weekly support group meetings
Outcomes will be measured using standardized sleep scales actigraphy and daily sleep and exercise logs
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAMD17-03-1-0082 | None | None | None |