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NCT Number: NCT06857123

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

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.

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Key information

Age range

45 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Sara R Piva, PhD, PT, FAPTA

CONTACT

[email protected]

412-383-6712

Sara R Piva, PhD, PT, FAPTA

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise with Rest

Behavioral

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.

Exercise without Rest

Behavioral

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.

Primary outcomes

  1. Feasibility of recruitment

    Time frame: 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 outcomes

  1. Safety of interventions

    Time frame: 3 months (window of 1 month)

    The number of adverse events related to study participation in each arm

Other outcomes

  1. Adherence to Intervention

    Time frame: 3 months (window of 1 month)

    The number of intervention sessions attended out of the total number of intervention sessions prescribed in the study.

  2. Study retention

    Time frame: 3 months (window of 1 month)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Carnegie Mellon University

Registry information

Official study title

Mechanical and Molecular Determinants of Cartilage Response to Exercise

Acronym: CaRE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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