Overcoming TWEAK Signaling to Restore Muscle and Mobility After Joint Replacement

Completed · Not applicable

Conditions studied: Osteoarthritis

In brief

This single-blind, randomized, controlled trial is designed to test the effect of an intensive, 16 week exercise rehabilitation program (progressive resistance training + functional mobility training) vs. usual care on restoration of muscle mass and mobility after total hip (THA) or knee (TKA) arthroplasty in men and women with end-stage osteoarthritis. The molecular basis underlying the trial is the presence of significant muscle inflammation susceptibility in many of these individuals, and the expectation that the more intensive intervention will overcome this inflammatory burden to facilitate recovery.

Key facts

Study ID

NCT02628795

Run by

University of Alabama at Birmingham

People needed

80

Starts

2015-10-01

Expected to finish

2021-02-28

Last updated by the study team

2021-07-07

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between the ages 40 and 80 y.
• Scheduled to undergo elective total hip or knee replacement specifically for the surgical indication of end-stage osteoarthritis.
• First-time hip or knee replacement.
• Capable of providing informed consent (cognitively intact if consenting to surgery).

You may not qualify if…

• Any surgical indication other than first-time total joint replacement specifically for end-stage osteoarthritis.
• Bilateral knee/ hip replacement
• History of alcoholism or liver disease.
• Any history of hypo- or hyper-coagulation disorders including subjects taking Coumadin.
• Any individual with end-stage disease and/or a life expectancy less than one year.
• Pregnancy.
• Lactating Women.
• Neurological, musculoskeletal, or other disorder that would preclude them from completing the exercise training intervention and all performance tests.
• Uncontrolled hypertension, unstable or exercise-induced angina pectoris or myocardial ischemia, congestive heart failure.
• Uncontrolled diabetes mellitus.
• Any other condition or events considered exclusionary by the PIs and/or physician Co-Is.
• Lidocaine allergy (1% lidocaine is the local anesthetic used during the muscle biopsy procedure).
• Phenylketonuria (phenylalanine tracer for metabolic studies).
• Currently receiving androgen (e.g., testosterone) or anabolic (e.g., growth hormone (GH), insulin-like growth factor-I (IGF-I)) therapy.
• Body mass index ≥ 35.
• History of lower body progressive resistance training within the past year.

Where it is running

• UAB Center for Exercise Medicine — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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