Knee Osteoarthristis
Conditions
Keywords
Knee, Osteoarthritis, exercise, feasibility
Brief summary
This pilot randomize trial tests the feasibility of administering two different exercise programs in people with knee osteoarthritis. One group receives the exercise program administered as usual, and the other group received the exercise program with resting intervals.
Detailed description
Participants will be randomly assigned to 1 of 2 treatment groups. Both groups do the same exercise program 3 times a week for 12 weeks on nonconsecutive days. The only difference is that one group will perform the exercises with small resting periods between exercises as normally done in clinical practice. The other group will have two long rests of 45 minutes during the exercise training session. Before and after the exercise programs, participants will undergo a series of assessments including gait analysis, MRI imaging of knees, tests of muscle strength and physical performance. Questionnaires will be completed. Blood and synovial fluid will be collected as part of this study.
Interventions
BEHAVIORALExercise with Rest
Participants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include two 45 minute rest periods between exercises and take about two and a half hours.
BEHAVIORALExercise without Rest
Participants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include minimal resting periods between exercises and take about one hour.
Sponsors
University of Pittsburgh
Carnegie Mellon University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Age between 45 and 79 yo. * Clinical diagnosis of primary, early to moderate stage knee osteoarthritis. * BMI range \< 35 kg/m2. * Sedentary lifestyle * Knee joint is the most painful joint in the body. * Ability to speak and understand English. * Willingness to comply with all study procedures and be available for the duration of the study.
Exclusion criteria
* Non-OA disease of the knee. * Advanced knee osteoarthritis * Knee injection in the past 3 months. * Major knee trauma/surgery in the past 5 years or previous knee surgery with hardware limiting cartilage assessment.. * Participate in regular exercise or physical activity . * Participation in an intervention study for knee OA. * Currently using a cane, walker or crutches to walk. * History of cardiovascular disease or hypertension not controlled by medication. * Two or more unexplained falls in the past year. * Inflammatory, autoimmune disorders, neurological, systemic, muscular, or connective tissue conditions that affect walking or ability to exercise. * Contraindication to MRI. * Medical condition or characteristic of the participant that could place the individual at increased risk or preclude s/he from complying with study procedures. * Pregnant female. * Acute or terminal illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of recruitment | The time frame for this outcome is from the enrollment period up to randomization. This outcome measure is independent of treatment assignment. | The number of eligible individuals who are randomized out of all eligible individuals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of interventions | 3 months (window of 1 month) | The number of adverse events related to study participation in each arm |
Countries
United States
Contacts
CONTACTGaupp
PRINCIPAL_INVESTIGATORSara Piva
University of Pittsburgh
Outcome results
None listed