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Completed

NCT Number: NCT04235309

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

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).

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Key information

Conditions

Resilience Aging

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke Regional Hospital, Durham, North Carolina, United States

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About this study

In general, a person's specific resilience (ability to bounce back from a stressor) is thought to be dependent upon that person's specific biological and genetic makeup. However, these specific elements remain poorly understood. The purpose of this study is to identify important predictors and characteristics of resilience in response to a total knee replacement by examining baseline resilience (prior to surgery) and post-surgical resilience at multiple time points, allowing us to track resilience outcomes over time.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 60 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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline, 1 week, 1 month, 2 months, 4 months and 6 months

    As measured by a Garmin device worn by participants

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

    Time frame: Baseline, 6 months

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

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

    Time frame: Baseline, 1 week, 1 month, 2 months, 4 months and 6 months

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

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

    Time frame: Baseline, 1 week, 1 month, 2 months, 4 months and 6 months

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

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

    Time frame: Baseline, 1 week

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

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

    Time frame: Baseline, 1 month, 2 months, 4 months, 6 months

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

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

    Time frame: Baseline, 1 month, 2 months, 4 months, 6 months

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

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

    Time frame: Baseline, Post-operative Day 1

    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.

Secondary outcomes

  1. Change in dual task gait speed

    Time frame: Baseline, 6 months

    Score of combined walking and verbal fluency test

  2. Change in tissue oxygenation index (TOI)

    Time frame: Baseline, 6 months

    Measured using fNIRs (functional near infrared spectroscopy)

  3. Intraoperative electrocardiography (ECG) RR variability

    Time frame: Surgery up to three hours

    Measured as intra-operative ECG RR intervals collected from the heart monitor

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: PRIME-Knee

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 21, 2020
Registry last updated
Dec 8, 2025

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.

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