Understanding Changes in Physical Function Using Principl... | NCT05581082

NCT05581082

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)	Other: Pragmatic, exploratory study of Precision Medicine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pragmatic, exploratory study of Precision Medicine	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in blood sample	The team will collect a blood sample at baseline (0- weeks) and follow-up (12-weeks) to conduct an untargeted metabolomic analysis to demonstrate potential peaks of protein within the blood reported in mg/dL.	Up to 12 weeks
Change in serum sample	The team will collect a blood sample at baseline (0- weeks) and follow-up (12-weeks) to conduct an untargeted metabolomic analysis to demonstrate potential peaks of protein within the blood reported in g/dL.	Up to 12 weeks
Patient Reported Outcome Measure Information System-Global Health Questionnaire used to determine changes in Physical Function	Providers will use the Patient Reported Outcome Measure Information System-Global Health Questionnaire to gauge physical, mental, and social aspects of health (5-point scale) to record the changes in physical function prior and after beginning the physical-therapy based program. A mean standardized score for the population is 50; 10 points indicate one standard deviation. Higher scores indicate better health.	Up to 12 weeks
Pittsburgh Fatigability Scale used to determine changes in Physical Function	Providers will use the Pittsburgh Fatigability Scale will measure the fatigue of each sedentary, social, lifestyle, and physical activities to record the changes in physical function prior and after beginning the physical-therapy based program. 10 items total for physical and mental fatigue are summed to create two separate continuous scores, each ranging from 0 to 50. Higher scores indicate greater perceived physical or mental fatigability	Up to 12 weeks
Patient Activation Measure Survey used to determine changes in Physical Function	Providers will use the Patient Activation Measure Survey will assess knowledge, skills, and confidence for managing health revealing insights into motivators, behaviors, attitudes, and outcomes to record the changes in physical function prior and after beginning the physical-therapy based program. An interval-level scale from 0-100. A lower patient activation score indicates a patient who is less active in managing their health, whereas a higher patient activation score indicates a patient who is more active in managing their health.

Eligibility Module

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;

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms