Understanding Changes in Physical Function Using Principles of Precision Medicine

June 21, 2024 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 99 years (Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in blood sample
Time Frame: Up to 12 weeks
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
Time Frame: Up to 12 weeks
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
Time Frame: Up to 12 weeks
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
Time Frame: Up to 12 weeks
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
Time Frame: Up to 12 weeks
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.
Up to 12 weeks
Saint Louis University Mental Status Examination Questionnaire used to determine changes in Physical Function
Time Frame: Up to 12 weeks
Providers will use Saint Louis University Mental Status Examination to test orientation, memory, attention, and executive function, with items such as animal naming, digit span, figure recognition, clock drawing and size differentiation to record the changes in physical function prior and after beginning the physical-therapy based program (30-point, 11 questions total) Scores of 27 to 30 are considered normal in a person with a high school education. Scores between 21 and 26 suggest a mild neurocognitive disorder. Scores between 0 and 20 indicate dementia.
Up to 12 weeks
Community Healthy Activities Model Program for Senior Questionnaire used to determine changes in Physical Function
Time Frame: Up to 12 weeks
Providers will use Community Healthy Activities Model Program for Senior Questionnaire to assesses weekly frequency and duration of various physical activities typically undertaken by older adults. Four different scores can be derived from the questionnaire: frequency of moderate or greater activity (MET >3.0, a composite score that ranges from 0 to 40, with higher scores indicating better performance); frequency of all physical activity (light, moderate, and vigorous); caloric expenditure of moderate or greater activity (light, moderate, vigorous); caloric expenditure of moderate or great activity; caloric expenditure of all physical activity.
Up to 12 weeks
Brief Resilience Scale used to determine changes in Physical Function
Time Frame: Up to 12 weeks
Providers will use the Brief Resilience Scale to assess the ability to bounce back or recover from stress in order to record the changes in physical function prior and after beginning the physical-therapy based program. 6 total questions, scoring is on a range of 1-5. Once all six statements have been assessed, the total of the number is taken. This summing up will give an overall resilience score of between 6 and 30. Lower scores indicate lower levels of resilience.
Up to 12 weeks
Rapid Eating Assessment for Participants used to determine changes in Physical Function
Time Frame: Up to 12 weeks
Providers will use Rapid Eating Assessment for Participants to perform a brief assessment of diet and physical activity to record the changes in physical function prior and after beginning the physical-therapy based program (Total scores range from 13 to 39 --higher quantities represent dietary quality characterized by optimal intake of fruits, vegetables, and whole grains and decreased intake of sugary foods, processed meats, and fried foods).
Up to 12 weeks
Patient Health Questionnaire used to determine changes in Physical Function
Time Frame: Up to 12 weeks
Providers will use the Patient Health Questionnaire to identify signs or symptoms of depression to record the changes in physical function prior and after beginning the physical-therapy based program (9 questions total, ≤ 4 The score suggests the patient may not need depression treatment, >5-14 along with physician clinical judgment about treatment, based on patient's duration of symptoms and functional impairment, ≥ 15 Warrants treatment for depression, using antidepressant, psychotherapy and/or a combination of treatment).
Up to 12 weeks
Gait Speed used to determine changes in Physical Health.
Time Frame: Up to 12 weeks
Providers will use gait speed to assess a comfortable gait speed for the patient to determine changes in physical health. Scale: healthy women aged 70-79 years is 1.13 meters per second (m/s) and for men 1.26 m/s. For women and men aged 80-99 the values are 0.94 meters per second (m/s) and 0.97 meters per second (m/s), respectively.
Up to 12 weeks
Grip Strength used to determine changes in Physical Health
Time Frame: Up to 12 weeks
Providers will use grip strength to assess a comfortable gait speed for the patient to determine changes in physical health. Scale: Optimal cut-points were 24.9 kg for men 65-74 years, 20.8 kg for men 75-90 years, 15.2 kg for women 65-74 years, and 13.5 kg for women 75-90 years.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Batsis, MD, UNC Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-1230

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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