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

NCT06857123 | Recruiting

• 1 other identifier: STUDY23050179
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Knee; Osteoarthritis; exercise; feasibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety of interventions

  3 months (window of 1 month)

Other Outcomes (2)

• Adherence to Intervention

  3 months (window of 1 month)

• Study retention

  3 months (window of 1 month)

Study Arms (2)

Exercise With Rest

EXPERIMENTAL

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

Exercise Without Rest

ACTIVE COMPARATOR

Exercise without Rest

Behavioral: Exercise without Rest

Interventions

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.

Exercise Without Rest

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 With Rest

Eligibility Criteria

• Age: 45 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Carnegie Mellon University: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Motor Activity

Interventions

Exercise; RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sara Piva

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaupp

CONTACT

412-383-0742; awg26@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair for Research

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: March 4, 2025
• Study Start: December 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available at the time of the publication of the pilot feasibility results in peer-reviewed medical journal.
• 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.

Locations

US (1)