Understanding Changes in Physical Function Using Principles of Precision Medicine

NCT ID: NCT05581082

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-30
• Study Completion Date: 2023-09-30

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.

Conditions

Frailty

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Routine Clinical Care with PCP

All individuals will be seen by their primary care physician (PCP) in Geriatric Clinic. Patients previously diagnosed with frailty per their PCP. Their PCP visit will include independent assessment and physical therapy referral, and will begin a physical therapy-based strengthening intervention. Patients will be independently managed (assessment and intervention) by a Physical Therapist (PT). The PT will initiate an intervention plan (e.g., education and exercise)

Pragmatic, exploratory study of Precision Medicine

Intervention Type: OTHER

This pragmatic, exploratory study consists of individuals with frailty who are referred from routine care to a physical therapy-based strengthening intervention. This specific study will collect ancillary measures to evaluate our outcomes. The study staff will not be conducting any interventions themselves - the physical therapy program is as per usual care.

Interventions

Pragmatic, exploratory study of Precision Medicine

This pragmatic, exploratory study consists of individuals with frailty who are referred from routine care to a physical therapy-based strengthening intervention. This specific study will collect ancillary measures to evaluate our outcomes. The study staff will not be conducting any interventions themselves - the physical therapy program is as per usual care.

Intervention Type: OTHER

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;

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Batsis, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

22-1230

Identifier Type: -

Identifier Source: org_study_id