Clinical trial NCT04235309: Physical Resilience: Indicators and Mechanisms in the Elderly (PRIME) Collaborative Phase 2
Official title: Physical Resilience: Indicators and Mechanisms in the Elderly (PRIME) Collaborative Phase 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resilience
Aging
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-01-21
Enrollment: 297
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in musculoskeletal resiliency following orthopedic surgery as measured by physical activity (step counts)
timeFrame: Baseline, 1 week, 1 month, 2 months, 4 months and 6 months
measure: Change in musculoskeletal resiliency following orthopedic surgery as measured by Lower Extremity Physical Activities of Daily Living (LE PADLs)
timeFrame: Baseline, 6 months
measure: Change in musculoskeletal resiliency following orthopedic surgery as measured by PROMIS Pain Intensity
timeFrame: Baseline, 1 week, 1 month, 2 months, 4 months and 6 months
measure: Change in musculoskeletal resiliency following orthopedic surgery as measured by PROMIS Pain Interference
timeFrame: Baseline, 1 week, 1 month, 2 months, 4 months and 6 months
measure: Change in cognitive resiliency following orthopedic surgery as measured by 3D-CAM.
timeFrame: Baseline, 1 week
measure: Change in cognitive resiliency following orthopedic surgery as measured by cognitive change index (CCI) for patient.
timeFrame: Baseline, 1 month, 2 months, 4 months, 6 months
measure: Change in cognitive resiliency following orthopedic surgery as measured by cognitive change index (CCI) for informant about patient.
timeFrame: Baseline, 1 month, 2 months, 4 months, 6 months
measure: Change in association between in vitro immune resiliency and resilient outcomes following elective orthopedic surgery.
timeFrame: Baseline, Post-operative Day 1
Secondary outcomes:
measure: Change in dual task gait speed
timeFrame: Baseline, 6 months
measure: Change in tissue oxygenation index (TOI)
timeFrame: Baseline, 6 months
measure: Intraoperative electrocardiography (ECG) RR variability
timeFrame: Surgery up to three hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Regional Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Cathleen S Colon-Emeric, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Heather E Whitson, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: