Feasibility of Resting Intervals During Exercise Programs for Individuals with Knee Osteoarthritis

Not Applicable

Recruiting

• Conditions: Knee Osteoarthristis

• Registration Number: NCT06857123
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2024-12-04
• Study First Submitted: 2025-01-17
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety of interventions	3 months (window of 1 month)	The number of adverse events related to study participation in each arm

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States