A Personalized Prehabilitation Intervention In Elective Joint Replacement Surgery

NCT03601728 | Suspended

• 1 other identifier: 826962
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The mission is to develop novel interventions to improve cognitive function, and thereby reducing delirium in hospitalized patients to improve perioperative outcomes. Delirium affects up to 42% of hospitalized patients and disproportionately increases morbidity and mortality in older adults, especially after surgical procedures. Current approaches prevent only 30-40% of delirium cases. The goal is to use prehabilitation (an individualized exercise regimen performed in the 2-4 weeks prior to admission) to improve peri-operative cognitive status, mobility and recovery. Based on preliminary data, the investigators propose to deeply phenotype patients, meaning to study the patient, the disease and surgery in a very detailed fashion, with elective knee or hip replacement surgery and use a personalized prehabilitation intervention compared to standard pre-operative care. To facilitate data collection over the course of the study, the investigators use wearable devices and mobile phone applications.

Conditions

Arthropathy of Knee Joint; Arthropathy of Hip Joint

Keywords

elective

Outcome Measures

Primary Outcomes (1)

• Change from baseline, pre-prehabilitation cognitive function at 30±2 days post-operative

  Difference in cognitive function as assessed by the CogState Brief Battery for the condition 'baseline, pre-prehabilitation' versus 30±2 days post-operative between Intervention vs. Control

  30±2 days post-operative

Secondary Outcomes (10)

• Change from baseline, pre-prehabilitation physical activity [vector magnitude] at 30±2 days post-operative

  30±2 days post-operative

• Change from baseline, pre-prehabilitation step count [number] at 30±2 days post-operative

  30±2 days post-operative

• Change from baseline, pre-prehabilitation sleep duration [hours] at 30±2 days post-operative Difference in sleep parameters

  30±2 days post-operative

• Change from baseline, pre-prehabilitation circadian phase [hours] of activity

  30±2 days post-operative

• Change from baseline, pre-prehabilitation circadian amplitude [difference between the maximum and minimum observed values] of activity

  30±2 days post-operative

Study Arms (2)

Enhanced Monitoring Program

EXPERIMENTAL

Four weeks prior to the scheduled (elective) surgery, participants will receive a 60-minute in person education session how to increase the level of physical activity. This will be followed by 4 weeks of keeping this level of physical activity, which will be monitored and supported by personalized interactive prompts delivered by a smartwatch. This approach is called personalized prehabilitation.

Behavioral: personalized prehabilitation

Regular Monitoring Program

NO INTERVENTION

Participants randomized to this arm will receive standard perioperative care.

Interventions

personalized prehabilitation BEHAVIORAL

The 60-minute education session includes a 30-minute general education on exercise in older adults and a 30-minute instruction on participating in the study intervention (how to work with the personalized circadian-based activity guideline). The education session will be developed and presented by the PI and the certified exercise trainer. The general education session will be designed using materials from Go4Life program from the National Institute on Aging (https://go4life.nia.nig.gov). The personalized circadian-based activity guideline (exercise goal and plan) will be developed by the investigators and the exercise trainer based on the individual's typical daily circadian profile, functional status, preference for exercise.

Also known as: Enhanced Monitoring Program

Enhanced Monitoring Program

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults scheduled for elective arthroplasty;
• ≥55 years of age;
• Capable of giving informed consent;
• Willing to comply either to undergo prehabilitation (cases) or standard preoperative care (control);
• Own a smartphone.

You may not qualify if:

• Patients with bilateral or revision surgeries;
• Diagnosis of pre-existing dementia;
• Test result of \<20 in the MoCA indicating moderate to severe dementia;
• Diagnosis of acute stroke;
• Diagnosis of neurologic injury;
• Current alcohol (more than 2 drinks a day with last drink within the past 3 days) or substance abuse (positive urine dip test for illicit drugs) history at risk of postoperative withdrawal;
• Active diagnosis of alcohol or substance abuse;
• Recent travel across more than two (2) time zones (within the past month);
• Planned travel across more than two (2) time zones during the planned study activities;
• Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening;
• Subjects without access to WiFi in their or close to home or at work.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Skarke C, Lahens NF, Rhoades SD, Campbell A, Bittinger K, Bailey A, Hoffmann C, Olson RS, Chen L, Yang G, Price TS, Moore JH, Bushman FD, Greene CS, Grant GR, Weljie AM, FitzGerald GA. A Pilot Characterization of the Human Chronobiome. Sci Rep. 2017 Dec 7;7(1):17141. doi: 10.1038/s41598-017-17362-6.

  PMID: 29215023 BACKGROUND

Related Links

• Study support by the Penn Center for Precision Medicine (PCPM)
• Study description in a 1-minute YouTube video

Study Officials

• Carsten Skarke, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Matched case-control study design

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: July 26, 2018
• Study Start: October 1, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)