Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00007241
Status:
COMPLETED
Last Update Posted:
2007-01-04
First Post:
2000-12-16
Brief Title:
Muscle Strengthening Device for Knee Osteoarthritis
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Osteoarthritic Knee Isometric Exerciser for Home Use
Status:
COMPLETED
Status Verified Date:
2003-02
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:
Studies have shown that isometric strengthening helps people with osteoarthritis of the knee Isometric strengthening is muscle-strengthening exercise without movement in which a person applies a force against a resistant object--for example pushing against a brick wall This study will test the effectiveness of a portable isometric exercise device for home use that guides a person through an exercise program using various forms of feedback We will look at whether people exercising with the device achieve better outcomes results in pain stiffness strength and functional measures compared to people who do not use the device or people exercising according to printed material from arthritis organizations
Detailed Description:
Previous studies have shown that isometric strengthening is beneficial in managing osteoarthritis of the knee This type of exercise can decrease joint-related pain and stiffness while increasing strength and functional measures However individuals rarely adhere to isometric exercise for any lengthy period of time because there has not been a way to measure applied force and performance over time in the home setting In addition this type of exercise has often been described as boring We believe that being able to monitor ones progress is essential in maintaining adherence to an isometric exercise program This study will examine the effectiveness of a portable isometric exercise device for home use that guides the user through an exercise protocol by means of various forms of feedback
We hypothesize that individuals exercising with the device will achieve better outcomes in pain stiffness strength and functional measures than a control group or a group exercising according to printed material from arthritis advocacy groups We will randomly assign study participants meeting eligibility criteria to the exercise device group exercise according to printed material group or control group We will conduct measures in all groups during a clinic visit at baseline 2 4 6 and 8 weeks As subjects in the exercise device group strengthen their leg muscles a physical therapist will likely need to adjust upward the target force for different leg positions during every clinic visit 2 weeks apart
We hypothesize that individuals exercising with the device will achieve better outcomes in pain stiffness strength and functional measures than a control group or a group exercising according to printed material from arthritis advocacy groups We will randomly assign study participants meeting eligibility criteria to the exercise device group exercise according to printed material group or control group We will conduct measures in all groups during a clinic visit at baseline 2 4 6 and 8 weeks As subjects in the exercise device group strengthen their leg muscles a physical therapist will likely need to adjust upward the target force for different leg positions during every clinic visit 2 weeks apart
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 |
|---|---|---|---|
| NIAMS-053 | None | None | None |