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

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ClinicalTrials.gov Identifier: NCT04235309
Recruitment Status : Suspended (COVID-19 social distancing requirements.)
First Posted : January 21, 2020
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
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).

Condition or disease
Resilience Aging

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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physical Resilience: Indicators and Mechanisms in the Elderly (PRIME) Collaborative Phase 2
Actual Study Start Date : February 27, 2020
Estimated Primary Completion Date : February 27, 2023
Estimated Study Completion Date : February 27, 2023

Group/Cohort
Total Knee Replacement Cohort
Any patients who are scheduled to undergo a total knee replacement.



Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Blood samples will be collected from study participants at the baseline visit (before surgery) and 24 hours after surgery.


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04235309


Locations
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United States, North Carolina
Duke Regional Hospital
Durham, North Carolina, United States, 27704
Duke University Hospital
Durham, North Carolina, United States, 27710
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Cathleen Colon-Emeric, MD Duke University
Principal Investigator: Heather E Whitson, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04235309    
Other Study ID Numbers: Pro00103483
4UH3AG056925-03 ( U.S. NIH Grant/Contract )
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No