An observational study in Osteoarthritis, Knee, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-02-27.
Sponsored by Milton S. Hershey Medical Center · Observational
The primary objective is to evaluate water based treadmill exercise, land based treadmill exercise, and upright cycling in meeting American College of Sports Medicine exercise goals for moderate exercise.
The secondary objective is to compare exercise tolerance for water based treadmill, land based treadmill, and upright cycling in meeting American College of Sports Medicine exercise goals for moderate exercise.
The tertiary objective is to evaluate quality of life improvements for water based treadmill exercise, land based treadmill exercise, and upright cycling.
Osteoarthritis is the most common joint disorder in the United States, affecting approximately 26.9 million adults greater than 25 years of age. This disorder can be very debilitating: more than 40% of adults with doctor diagnosed arthritis have reported that joint symptoms cause them to modify their activities. Risk of disability (defined as needing help walking or climbing stairs) associated with osteoarthritis is considered equivalent to cardiovascular disease and is greater than any other medical condition in elderly patients [13]. Persons with disability associated with osteoarthritis have a substantially worse health-related quality of life, in large part due to their inability to exercise.
Exercise has been shown to help maintain function in knee osteoarthritis [5]. Aerobic walking and quadriceps strengthening exercises ([18];[7]) and resistance training [15] have demonstrated that exercise can potentially improve pain and function in individuals with knee osteoarthritis. Likewise, a Cochrane review on aquatic exercise provided gold level evidence that aquatic exercise probably reduces pain and increases function over 3 months; but, it stated clearly that more research was needed to understand which type of aquatic exercise, how often, and for how long might be beneficial [2]. The American College of Sports Medicine (ACSM) recommendations for healthy adults recommend moderate-intensity aerobic exercise (endurance) physical activity for a minimum of 30 minutes, 5 days per week or vigorous-intensity aerobic physical activity for a minimum of 20 minutes, 3 days per week in all healthy adults aged 18 to 65 to promote and maintain health [9]. The best method of reaching current ACSM goals in patients with knee osteoarthritis is not known, as impact-related exercise certainly demands healthy joints and many patients with knee osteoarthritis do not tolerate this form of exercise.
In counseling patients with knee osteoarthritis, the question remains: how best to exercise to reach the ACSM goals for exercise. This study will compare water-based and land-based treadmill exercise and upright cycling in meeting ACSM exercise goals for moderate exercise.
Interested subjects will undergo knee radiographs to confirm presence and degree of knee osteoarthritis. Eligible participants will then be randomized into one of the three exercise cohorts. During each session, participants will complete between 10 to 45 minutes of exercise, with a goal of achieving 30 minutes of moderate aerobic exercise. All subjects will only participate in routine activities for the 8 week study period outside of the study protocol (no strength training, cardio training, etc.). Health status measurement questionnaires (WOMAC, KOOS, and SF12) will be completed at the time of randomization and at the conclusion of each week of exercise for a total of 9 times.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 791 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
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Subjects for this study will be recruited from Penn State Milton S. Hershey Medical Center and surrounding communities via internal and external advertisements.
Exclusion Criteria:
These subjects will participate in three monitored exercise sessions per week for 8 weeks using a water-based treadmill.
Behavioral: Water-based Treadmill
These subjects will participate in three monitored exercise sessions per week for 8 weeks using a land-based treadmill.
Behavioral: Land-based Treadmill
These subjects will participate in three monitored exercise sessions per week for 8 weeks using an upright exercise cycle.
Behavioral: Exercise Cycle
Exercise regimen: three monitored exercise sessions per week for eight weeks using the upright exercise cycle.
Also known as: Schwinn Windsprint Exercise Cycle
Exercise regimen: three monitored exercise sessions per week for eight weeks using the land-based treadmill.
Also known as: True CS 6.0 treadmill, Nautilus NTR 700 treadmill
Exercise regimen: three monitored exercise sessions per week for eight weeks using the water-based treadmill.
Also known as: Hydroworx 2000 Series pool treadmill
Exercise Tolerance
Exercise tolerance will be assessed based upon changes in symptoms related to knee osteoarthritis and exercise limitations related to those symptoms.
Time frame: 8 weeks
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Milton S. Hershey Medical Center