Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible. 

Study Description

The definitive treatment for knee osteoarthritis is Total Knee Replacement (TKR), which results in clinically meaningful improvements in pain and physical function. However, evidence suggests that physical activity remains unchanged after TKR. This randomized clinical trial is investigating the efficacy, fidelity, and safety of a physical therapist administered physical activity intervention for people after TKR.

This study is designed to fill a critical clinical need to increase physical activity after TKR. The primary objective of the study is to evaluate the efficacy of a physical therapist administered physical activity intervention for people after TKR. The secondary objectives are to evaluate the fidelity and safety of a physical therapist administered physical activity intervention for people after TKR and to investigate changes in self-reported and performance-based physical function after a physical therapist administered physical activity intervention for people after TKR. The tertiary objective is to explore the association of psychosocial factors with physical activity 6 and 12 months after discharge from a physical therapist administered physical activity intervention for people after TKR. The findings will be used to support a large multi-site clinical trial to test the effectiveness, implementation, and cost of this intervention.

ELIGIBILITY CRITERIA:

Ages Eligible for Study:           45 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:          All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

  • Over the age of 45
  • Seeking outpatient physical therapy for a unilateral TKR

Exclusion Criteria:

  • Not interested in increasing physical activity
  • Any other medical conditions that limit your physical activity
  • Have had or are planning on having another leg surgery within 6 months that is unrelated to your TKR surgery
  • Previously enrolled in a physical activity intervention study at this clinic

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Single (Outcomes Assessor)

Primary Purpose: Treatment

Study Location(s):

University of Delaware, Newark, Delaware, United States, 19713

Study Website:

https://clinicaltrials.gov/ct2/show/NCT03228719?term=NCT03228719&rank=1

Last Updated: August 2019