Northwestern University
Chicago, Illinois, 60611, United States
NCT Number: NCT02728661
PACE is a patient-centered weight loss program that was developed specifically for knee replacements based on input from stakeholders, including knee replacement patients, physical therapists, and orthopedic surgeons. In this pilot study, participants undergoing knee replacement will be randomized to either start a weight loss program before surgery (PACE) or after surgery (Delayed PACE). Both programs will receive a 14-week intervention and complete assessments at baseline (up to 6 weeks prior to surgery), 12 weeks after surgery, and 26 weeks after surgery.
Looking for future studies?
Notify Me40 year–79 year
All sexes
Interventional
Phase 1 / Phase 2
Chicago, Illinois, 60611, United States
It is estimated that half of patients diagnosed with knee osteoarthritis (OA) will need a total knee replacement (TKR) during their lifetime. Of patients who need a TKR, 80-95% are overweight or obese. While patients are encouraged to lose weight, limited, if any, guidance is provided to achieve recommended weight loss. Many patients perceive that TKR is a necessary precursor for the initiation of weight loss. Yet, 66% of patients actually gain weight by 2 years after surgery. Patients undergoing TKR not only face unique barriers (i.e., pain, mobility limitations, motivation) to weight loss, but also have to balance pre- and post-operative concerns from physicians, surgeons, and rehabilitation specialists. To best accommodate the needs of both patients (pre- and post-TKR) and healthcare professionals (i.e., surgeon, physical therapist), patient and stakeholder engagement and activation is imperative in the development of a patient-centered weight loss intervention. Investigators completed 20 interviews with patients pre- and post-TKR and identified weight loss barriers, preferred intervention components (e.g., delivery method, contact frequency, self-monitoring modality) and patient-reported outcomes (e.g., physical function, pain) viewed as critical by patients. Investigators developed a patient-centered weight loss program (PACE) guided by these results and additional input from stakeholders to meet the needs of patients and healthcare professionals. PACE is a randomized pilot study comparing weight loss and patient-reported outcomes between PACE (program starting up to 6 weeks pre-TKR to 12 weeks post-TKR) and Delayed PACE (program starting 12 weeks post-TKR to 26 weeks post-TKR).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PACE is an 14 week behavioral weight loss intervention developed specifically for knee replacement patients that starts up to 6 weeks prior to surgery.
Delayed PACE is an 14 week behavioral weight loss intervention developed specifically for knee replacement patients that starts 12 weeks after surgery.
Time frame: Change from baseline to 12 and 26 weeks
Time frame: Change from baseline to 12 and 26 weeks
Time frame: Change from baseline to 12 and 26 weeks
Time frame: Change from baseline to 12 and 26 weeks
Time frame: 26 weeks post-op
Northwestern University
Other
Acronym: PACE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03407885
Arthroplasty, Replacement
View Trial DetailsNCT01857349
Arthroplasty, Replacement
Lubbock, Texas, United States
View Trial DetailsNCT04372173
Arthroplasty, Replacement, Cardiovascular Diseases
Warsaw, Poland
View Trial DetailsNCT01184989
Arthroplasty, Replacement, Moderate Renal Impairment (CrCl 30-50 mL/Min)
Graz, Austria
View Trial Details