Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT06857123

Conditions

Knee Osteoarthristis

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise with Rest

Exercise without Rest

Study Details

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.

Conditions

Knee Osteoarthristis

Study ID

NCT06857123

Start date

Dec 4, 2024

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Exercise Without Rest

Exercise without Rest

Interventions

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.

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Gaupp

412-383-0742awg26@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Sara R Piva, PhD, PT, FAPTA

412-383-6712spiva@pitt.edu

Principal Investigator:

Sara R Piva, PhD, PT, FAPTA

More Information

Sponsor

University of Pittsburgh

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • Knee
  • Osteoarthritis
  • exercise
  • feasibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-02-09.