Clinical trial NCT05581082: Understanding Changes in Physical Function Using Principles of Precision Medicine
Official title: Understanding Changes in Physical Function Using Principles of Precision Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 18
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators aim to screen 35 patients in the clinic (40% ineligible + 15% drop out) to complete 18 participants.

Brief summary: This is a pilot, feasibility study and the purpose of this study is exploratory. The goal is to provide the PI and study team with data using metabolomics that can be used to: a) demonstrate an ability to use such data in a future grant application; b) obtain data that determines the relationship between changes in physical function (objective and subjective) and potential metabolites.

Detailed description: A pre/post, non-randomized, single-arm pilot natural clinical experiment trial of older adults (patients of UNC's Geriatrics Medicine Specialty Clinic, N=18) who will enroll in a physical therapy program as recommended by their primary care clinician. This pragmatic assessment consists of obtaining routine care data from the physical therapy visits and collecting blood to harness metabolomics data that can be used to: a) demonstrate an ability to use and analyze such data for a future grant application; b) determine the relationship between change in physical function and metabolites.

Eligibility criteria: Inclusion Criteria:

* Older adults ≥65 years (of all genders and sexes) with diagnosis of frailty based on the Fried phenotype A UNC Geriatrics Medicine Specialty clinic at the Eastowne Clinic patient who has been referred for physical therapy to Elderfit;
* \>2 Chronic medical conditions -these are based on the 21 Medicare multiple chronic conditions (e.g., alcohol abuse, Alzheimer's disease and related dementia, arthritis (osteoarthritis, rheumatoid), asthma, atrial fibrillation, autism spectrum disorders, cancer (breast, colorectal, lung, prostate), chronic kidney disease, chronic obstructive pulmonary disease, depression, diabetes, drug/substance abuse, heart failure, hepatitis, HIV/AIDS, hyperlipidemia, hypertension, ischemic heart disease, osteoporosis, schizophrenia/other psychotic disorders, stroke);
* Callahan cognitive screen ≥3 - this is a measure routinely used for clinical research in older adults. A screen of ≥3 suggests capacity to consent

Exclusion Criteria:

* Age \<65 years;
* A medical diagnosis of dementia - all participants are required to have the ability to engage in the physical therapy-based intervention, complete questionnaires, and interact with others, all of which may be challenging in individuals with cognitive impairment;
* Individuals with life-threatening or untreated psychiatric diagnosis that would interfere with study participation and require significant modification to meet their needs such as untreated major depressive disorder, substance abuse, suicidal ideation or untreated severe mental illness (schizophrenia, bipolar disorder);
* Life-threatening illness including those receiving palliative care or hospice services;
* Individuals unwilling/unable to provide consent;
* Current participation in another physical therapy-based research study or program;
* Inability to complete the protocol procedures;
* Elective surgery in the next six months;
* Co-morbidities including: hospitalization for heart failure in past 6 months, history of advanced non-skin cancer (Stage III or IV); Advanced liver failure; Chronic renal insufficiency on hemodialysis;

Primary outcomes:
measure: Change in blood sample
timeFrame: Up to 12 weeks
measure: Change in serum sample
timeFrame: Up to 12 weeks
measure: Patient Reported Outcome Measure Information System-Global Health Questionnaire used to determine changes in Physical Function
timeFrame: Up to 12 weeks
measure: Pittsburgh Fatigability Scale used to determine changes in Physical Function
timeFrame: Up to 12 weeks
measure: Patient Activation Measure Survey used to determine changes in Physical Function
timeFrame: Up to 12 weeks
measure: Saint Louis University Mental Status Examination Questionnaire used to determine changes in Physical Function
timeFrame: Up to 12 weeks
measure: Community Healthy Activities Model Program for Senior Questionnaire used to determine changes in Physical Function
timeFrame: Up to 12 weeks
measure: Brief Resilience Scale used to determine changes in Physical Function
timeFrame: Up to 12 weeks
measure: Rapid Eating Assessment for Participants used to determine changes in Physical Function
timeFrame: Up to 12 weeks
measure: Patient Health Questionnaire used to determine changes in Physical Function
timeFrame: Up to 12 weeks
measure: Gait Speed used to determine changes in Physical Health.
timeFrame: Up to 12 weeks
measure: Grip Strength used to determine changes in Physical Health
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: John Batsis, MD
role: PRINCIPAL_INVESTIGATOR
References: