A Phase 2 interventional study of Isometric exercise in Osteoarthritis, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-01-04.
Sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Phase 2, Interventional, and Treatment
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.
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.
4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's enrollment of 92 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is the lead sponsor of 100 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)