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

NCT ID: NCT06857123

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-04
• Study Completion Date: 2026-01-31

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.

Conditions

Knee Osteoarthristis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise with Rest

Intervention Type: 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

Exercise without Rest

Group Type: ACTIVE_COMPARATOR

Exercise without Rest

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carnegie Mellon University

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Sara R. Piva

Professor and Vice Chair for Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Piva

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gaupp

Role: CONTACT

awg26@pitt.edu

412-383-0742

Facility Contacts

Sara R Piva, PhD, PT, FAPTA

Role: primary

spiva@pitt.edu

412-383-6712

Other Identifiers

STUDY23050179

Identifier Type: -

Identifier Source: org_study_id