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

Completed

• Conditions: Aging; Resilience

• Registration Number: NCT04235309
• Lead Sponsor: Duke University

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-21
• Study Start: 2020-02-27
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 297

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in musculoskeletal resiliency following orthopedic surgery as measured by physical activity (step counts)	Baseline, 1 week, 1 month, 2 months, 4 months and 6 months	As measured by a Garmin device worn by participants
Change in cognitive resiliency following orthopedic surgery as measured by 3D-CAM.	Baseline, 1 week	Scored as positive or negative. Positive indicates the presence of delirium.
Change in musculoskeletal resiliency following orthopedic surgery as measured by Lower Extremity Physical Activities of Daily Living (LE PADLs)	Baseline, 6 months	Scores are measured from 0 to 45. Higher scores are associated with more limited LE PADLs.
Change in musculoskeletal resiliency following orthopedic surgery as measured by PROMIS Pain Intensity	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.
Change in musculoskeletal resiliency following orthopedic surgery as measured by PROMIS Pain Interference	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.
Change in association between in vitro immune resiliency and resilient outcomes following elective orthopedic surgery.	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.
Change in cognitive resiliency following orthopedic surgery as measured by cognitive change index (CCI) for patient.	Baseline, 1 month, 2 months, 4 months, 6 months	Scores range from 20 - 100. Higher scores are associated with increased cognitive decline.
Change in cognitive resiliency following orthopedic surgery as measured by cognitive change index (CCI) for informant about patient.	Baseline, 1 month, 2 months, 4 months, 6 months	Scores range from 20 - 100. Higher scores are associated with increased cognitive decline.

Secondary Outcome Measures

Name	Time	Method
Intraoperative electrocardiography (ECG) RR variability	Surgery up to three hours	Measured as intra-operative ECG RR intervals collected from the heart monitor
Change in dual task gait speed	Baseline, 6 months	Score of combined walking and verbal fluency test
Change in tissue oxygenation index (TOI)	Baseline, 6 months	Measured using fNIRs (functional near infrared spectroscopy)

Trial Locations

Locations (3)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

Duke Regional Hospital; 🇺🇸 Durham, North Carolina, United States