ResiliencePRIME-KneeNCT04235309
Physical Resilience: Indicators and Mechanisms in the Elderly (PRIME) Collaborative Phase 2
An observational study of Resilience and Aging, run by Duke University at 3 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resilience, Aging
- How many people
- 297 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Feb 2020to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke Regional Hospital
Durham, North Carolina, 27704
Duke University Hospital
Durham, North Carolina, 27710
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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).
Read the 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.
- Conditions
- Resilience, Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Replacement Cohort | Any patients who are scheduled to undergo a total knee replacement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in musculoskeletal resiliency following orthopedic surgery as measured by physical activity (step counts)
As measured by a Garmin device worn by participants
Measured: Baseline, 1 week, 1 month, 2 months, 4 months and 6 months
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.
Measured: Baseline, 6 months
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.
Measured: Baseline, 1 week, 1 month, 2 months, 4 months and 6 months
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.
Measured: Baseline, 1 week, 1 month, 2 months, 4 months and 6 months
Change in cognitive resiliency following orthopedic surgery as measured by 3D-CAM.
Scored as positive or negative. Positive indicates the presence of delirium.
Measured: Baseline, 1 week
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.
Measured: Baseline, 1 month, 2 months, 4 months, 6 months
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.
Measured: Baseline, 1 month, 2 months, 4 months, 6 months
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.
Measured: Baseline, Post-operative Day 1
Secondary outcomes (3)
Change in dual task gait speed
Score of combined walking and verbal fluency test
Measured: Baseline, 6 months
Change in tissue oxygenation index (TOI)
Measured using fNIRs (functional near infrared spectroscopy)
Measured: Baseline, 6 months
Intraoperative electrocardiography (ECG) RR variability
Measured as intra-operative ECG RR intervals collected from the heart monitor
Measured: Surgery up to three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start27 Feb 2020
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResilienceStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Cathleen S Colon-Emeric, MD, MHS, Principal investigator, Duke UniversityHeather E Whitson, MD, MHS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235309
- Sponsor's protocol ID
- Pro00103483
- Other IDs
- 4UH3AG056925-03
- Acronym
- PRIME-Knee
- Status last verified
- Dec 2025
- First submitted
- 17 Jan 2020
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Resilience: Indicators and Mechanisms in the Elderly (PRIME) Collaborative Phase 2
- ClinicalTrials.gov ID
- NCT04235309
- Acronym / sponsor ID
- PRIME-Knee / Pro00103483
- Conditions
- Resilience, Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Knee Replacement Cohort | – | –Any patients who are scheduled to undergo a total knee replacement. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Change in dual task gait speed
Time frame: Baseline, 6 months
Change in tissue oxygenation index (TOI)
Time frame: Baseline, 6 months
Intraoperative electrocardiography (ECG) RR variability
Time frame: Surgery up to three hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Resilience
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Not yet recruiting
Effects of Art-Based Group Reminiscence Therapy on Resilience and Joy of Living in Older Adults
Resilience, Psychological, Joy of Living
Active, not recruiting
Emergency Preparedness for Caregivers of Persons With Dementia: Disaster PrepWise
Caregiver Resilience and Stress
Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathleen S Colon-Emeric, MD, MHS principal investigator
Duke University
Heather E Whitson, MD, MHS principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resilience and Aging, run by Duke University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.