Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT00387218
Status:
UNKNOWN
Last Update Posted:
2008-05-23
First Post:
2006-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Study For People With Parkinson's Disease
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Organization:
Study Overview
Official Title:
Exercise, Physical Function, and Parkinson's Disease
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
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:
This study is designed to compare three different exercise approaches to learn which program is best for people with early and mid-stage Parkinson's disease. Results from this study will help determine if participants can maintain the benefits from exercise and will help determine which program people with Parkinson's disease are more likely to continue using.
Detailed Description:
This is an intervention study that will determine whether an exercise program targeting spinal extremity range of motion for individuals with Parkinson's Disease, is superior to general conditioning and to 'usual care'. This study builds on previous findings of Schenkman and colleagues including the following: loss of spinal and extremity range of motion occur as sequelae to PD; these losses contribute significantly to early impairments of balance; and both spinal range of motion and balance of people with economy of movement is impaired in people who have PD. Specifically, we will examine whether the intervention, targeting range of motion and balance, also improves economy of movement.
Untreated impairments of range of motion, balance, and economy of movement may become highly disabling. Short term improvements of range of motion and balance occur with exercise. If the patient can sustain such improvements after a supervised exercise program is completed, these functionally limiting impairments may be delayed. Additionally, if exercises for spinal range of motion are coupled with functional retraining, the patient should improve in overall physical functional ability. Therefore, this study will establish the overall impact of a targeted exercise program for people with PD in terms of balance, economy of movement, and overall functional ability.
The study is a randomized clinical trial, with three treatment arms and four repeated measures: before treatment, after treatment, and follow-up after 10 months and again after 16 months. This study compares usual care based on the National Parkinson's Foundation, aerobic training, and targeted flexibility and functional training. The primary outcomes are measures of overall functional ability, balance and economy of movement. Secondary outcomes include measures of disease state, spinal range of motion, aerobic capacity, and quality of life.
Untreated impairments of range of motion, balance, and economy of movement may become highly disabling. Short term improvements of range of motion and balance occur with exercise. If the patient can sustain such improvements after a supervised exercise program is completed, these functionally limiting impairments may be delayed. Additionally, if exercises for spinal range of motion are coupled with functional retraining, the patient should improve in overall physical functional ability. Therefore, this study will establish the overall impact of a targeted exercise program for people with PD in terms of balance, economy of movement, and overall functional ability.
The study is a randomized clinical trial, with three treatment arms and four repeated measures: before treatment, after treatment, and follow-up after 10 months and again after 16 months. This study compares usual care based on the National Parkinson's Foundation, aerobic training, and targeted flexibility and functional training. The primary outcomes are measures of overall functional ability, balance and economy of movement. Secondary outcomes include measures of disease state, spinal range of motion, aerobic capacity, and quality of life.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| COMIRB #02-750 | None | None | View |