Feasibility of Resting Intervals During Exercise Programs for Individuals With Knee Osteoarthritis (CaRE)

Mechanical and Molecular Determinants of Cartilage Response to Exercise

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthristis
• Intervention / Treatment: Behavioral: Exercise with Rest; Behavioral: Exercise without Rest

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaupp; Phone Number: 412-383-0742; Email: awg26@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh
      • Contact: Sara R Piva, PhD, PT, FAPTA; Phone Number: 412-383-6712; Email: spiva@pitt.edu
      • Principal Investigator: Sara R Piva, PhD, PT, FAPTA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise 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.	Behavioral: Exercise 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.
Active Comparator: Exercise Without Rest; Exercise without Rest	Behavioral: Exercise 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	The number of eligible individuals who are randomized out of all eligible individuals.	The time frame for this outcome is from the enrollment period up to randomization. This outcome measure is independent of treatment assignment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of interventions	The number of adverse events related to study participation in each arm	3 months (window of 1 month)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Intervention	The number of intervention sessions attended out of the total number of intervention sessions prescribed in the study.	3 months (window of 1 month)
Study retention	The number of participants in each intervention arm who attend the follow-up assessment visit out of the number of participants randomized to each intervention arm.	3 months (window of 1 month)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Carnegie Mellon University
• Investigators: Principal Investigator: Sara Piva, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; exercise; Knee; feasibility
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Behavior; Osteoarthritis; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; RE1-silencing transcription factor
• Other Study ID Numbers: STUDY23050179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data supporting the conclusions of this study will be available upon request to the principal investigators. The data will include participants demographic and biomedical information, along with primary and secondary outcome measures. The data dictionary will be provided.
• IPD Sharing Time Frame: The data will be available at the time of the publication of the pilot feasibility results in peer-reviewed medical journal.
• IPD Sharing Access Criteria: IPD will be available upon request to the principal investigators. The data will include participants demographic and biomedical information, along with primary and secondary outcome measures. The data dictionary will be provided. Non-identifiable data will be shared in CSV files.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No