Physical Resilience: Indicators and Mechanisms in the Elderly (PRIME) Collaborative Phase 2

NCT04235309 | Completed DMC

• 2 other identifiers: Pro001034834UH3AG056925-03
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to examine underlying physical resilience (the ability to bounce back) in response to a specific stressor (total knee replacement).

Conditions

Resilience; Aging

Outcome Measures

Primary Outcomes (8)

• Change in musculoskeletal resiliency following orthopedic surgery as measured by physical activity (step counts)

  As measured by a Garmin device worn by participants

  Baseline, 1 week, 1 month, 2 months, 4 months and 6 months

• Change in musculoskeletal resiliency following orthopedic surgery as measured by Lower Extremity Physical Activities of Daily Living (LE PADLs)

  Scores are measured from 0 to 45. Higher scores are associated with more limited LE PADLs.

  Baseline, 6 months

• Change in musculoskeletal resiliency following orthopedic surgery as measured by PROMIS Pain Intensity

  Scores are measured from 3 to 15. Higher scores are associated with more intense pain.

  Baseline, 1 week, 1 month, 2 months, 4 months and 6 months

• Change in musculoskeletal resiliency following orthopedic surgery as measured by PROMIS Pain Interference

  Scores are measured from 6 to 30. Higher scores are associated with increased pain interference.

  Baseline, 1 week, 1 month, 2 months, 4 months and 6 months

• Change in cognitive resiliency following orthopedic surgery as measured by 3D-CAM.

  Scored as positive or negative. Positive indicates the presence of delirium.

  Baseline, 1 week

• Change in cognitive resiliency following orthopedic surgery as measured by cognitive change index (CCI) for patient.

  Scores range from 20 - 100. Higher scores are associated with increased cognitive decline.

  Baseline, 1 month, 2 months, 4 months, 6 months

• Change in cognitive resiliency following orthopedic surgery as measured by cognitive change index (CCI) for informant about patient.

  Scores range from 20 - 100. Higher scores are associated with increased cognitive decline.

  Baseline, 1 month, 2 months, 4 months, 6 months

• Change in association between in vitro immune resiliency and resilient outcomes following elective orthopedic surgery.

  Whole blood samples containing PBMCs collected before/after surgery will be challenged with LPS and influenza vaccine to assess the cellular immune response using previously identified biomarkers of resiliency and RNA-seq analysis to identify novel biomarkers and molecular signatures.

  Baseline, Post-operative Day 1

Secondary Outcomes (3)

• Change in dual task gait speed

  Baseline, 6 months

• Change in tissue oxygenation index (TOI)

  Baseline, 6 months

• Intraoperative electrocardiography (ECG) RR variability

  Surgery up to three hours

Study Arms (1)

Total Knee Replacement Cohort

Any patients who are scheduled to undergo a total knee replacement.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective observational study of n=250 adults aged 60 years and older undergoing elective total knee replacements with 6 months of follow-up.

You may qualify if:

• years of age or older
• Ability to speak English
• Planned elective knee replacement orthopedic surgery lasting 2 or more hours and requiring overnight observation or inpatient stay
• Community dwelling

You may not qualify if:

• Unable to ambulate independently, with or without assistive device
• Known dementia or screening 3MS score \<=77
• Inmate of a correctional facility (i.e. prisoners)
• Active non-skin cancer or medical treatment for non-skin cancer with 12 months (chemotherapy, radiation, immunotherapy, hormonal therapy)
• Vision or hearing impairment that, after best accommodation, prevents reliable cognitive assessment (visual/hearing) and/or precludes telephone interviews (hearing)

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Duke Regional Hospital

Durham, North Carolina, 27704, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected from study participants at the baseline visit (before surgery) and 24 hours after surgery.

Study Officials

• Cathleen S Colon-Emeric, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

• Heather E Whitson, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 21, 2020
• Study Start: February 27, 2020
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)