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

Aging Clinical Trial

— PRIME-Knee  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235309
• Other study ID #: Pro00103483
• Secondary ID: 4UH3AG056925-03
• Status: Completed
• Start date: February 27, 2020
• Est. completion date: October 30, 2023

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Resilience

Locations

Country	Name	City	State
United States	Duke Regional Hospital	Durham	North Carolina
United States	Duke University Hospital	Durham	North Carolina
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

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