Clinical trial NCT06857123: Feasibility of Resting Intervals During Exercise Programs for Individuals With Knee Osteoarthritis
Official title: Mechanical and Molecular Determinants of Cartilage Response to Exercise
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthristis
Keywords: Knee
Osteoarthritis
exercise
feasibility
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Carnegie Mellon University
First posted: 2025-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age between 45 and 79 yo.
* Clinical diagnosis of primary, early to moderate stage knee osteoarthritis.
* BMI range of 25 to 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.

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: The time frame for this outcome is from the enrollment period up to randomization. This outcome measure is independent of treatment assignment.
Secondary outcomes:
measure: Safety of interventions
timeFrame: 3 months (window of 1 month)
Other outcomes:
measure: Adherence to Intervention
timeFrame: 3 months (window of 1 month)
measure: Study retention
timeFrame: 3 months (window of 1 month)
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sara Piva
role: PRINCIPAL_INVESTIGATOR
References: