|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 16, 2000 | ||||
| Last Updated Date | January 2, 2007 | ||||
| Start Date ICMJE | September 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00007241 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Muscle Strengthening Device for Knee Osteoarthritis | ||||
| Official Title ICMJE | Osteoarthritic Knee Isometric Exerciser for Home Use | ||||
| 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 one's 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. |
||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Osteoarthritis | ||||
| Intervention ICMJE | Device: Isometric exercise | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Goldman RJ, Reinbold KA, Iglarsh ZA, Neustadter LM, Oatis CA, Schumacher HR. Phase I design and evaluation of an isometric muscle reeducation device for knee osteoarthritis rehabilitation. J Rehabil Res Dev. 2003 Mar-Apr;40(2):95-107. | ||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 92 | ||||
| Completion Date | July 2002 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00007241 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R44 AR45153, NIAMS-053 | ||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Verification Date | February 2003 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||