FrailtyNCT05581082

Understanding Changes in Physical Function Using Principles of Precision Medicine

An observational study of Frailty, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 65 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Frailty
What is being tested?: Pragmatic, exploratory study of Precision Medicine
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 30 Jul 2022to 30 Sep 2023
How long will I take part?: 12 Weeks
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 65 to 99 years
All sexes
Healthy volunteers accepted
Older adult

Study population: The investigators aim to screen 35 patients in the clinic (40% ineligible + 15% drop out) to complete 18 participants.

Who may be able to join

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

Who cannot join

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;

Show all 9Show fewer

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;

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Read the 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
Being tested: Pragmatic, exploratory study of Precision Medicine
Medical subject headings: Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pragmatic, exploratory study of Precision MedicineOther
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.

Study groups in NCT05581082
Study group	Role	What they receive
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) Receives: Other: Pragmatic, exploratory study of Precision Medicine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Up to 12 weeks
Saint Louis University Mental Status Examination Questionnaire used to determine changes in Physical Function
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.
Measured: Up to 12 weeks
Community Healthy Activities Model Program for Senior Questionnaire used to determine changes in Physical Function
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.
Measured: Up to 12 weeks
Brief Resilience Scale used to determine changes in Physical Function
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.
Measured: Up to 12 weeks
Rapid Eating Assessment for Participants used to determine changes in Physical Function
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).
Measured: Up to 12 weeks
Patient Health Questionnaire used to determine changes in Physical Function
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).
Measured: Up to 12 weeks
Gait Speed used to determine changes in Physical Health.
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.
Measured: Up to 12 weeks
Grip Strength used to determine changes in Physical Health
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.
Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 202230 Sep 2023

First posted14 Oct 2022
Study start30 Jul 2022
Primary completion30 Sep 2023
Study completion30 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for FrailtyStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe 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: Other
Time perspective: Prospective
Enrolment: 18 participants (actual)
Target duration: 12 Weeks

IDs, dates and publications

ClinicalTrials.gov ID: NCT05581082
Sponsor's protocol ID: 22-1230
Status last verified: Jun 2024
First submitted: 21 Sep 2022
Last updated: 25 Jun 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Frailty trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Understanding Changes in Physical Function Using Principles of Precision Medicine
ClinicalTrials.gov ID: NCT05581082
Acronym / sponsor ID: 22-1230
Conditions: Frailty
Study type: Observational
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Study start: 30 Jul 2022 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 30 Sep 2023 (actual)
First posted: 14 Oct 2022 (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.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Target follow-up: 12 Weeks
Number of arms: 1

Arm	Type	Receives
Routine Clinical Care with PCP	–	Other: Pragmatic, exploratory study of Precision MedicineAll 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)

Who may qualify

Ages: 65 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult
Study population: The investigators aim to screen 35 patients in the clinic (40% ineligible + 15% drop out) to complete 18 participants.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pragmatic, exploratory study of Precision MedicineThis 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.	Other	Routine Clinical Care with PCP

Primary outcome

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.
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.
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.
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
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.
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.
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.
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.
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).
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).
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.
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.

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 25 Jun 2024.

Related trials for Frailty

Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
Recruiting
Perioperative Multicomponent Rehabilitation and Outcomes in Elderly Patients With Frailty
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RecruitingObservational study
Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program
Frailty, Fall Risk, Fall Prevention
Not yet recruiting
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Acute Coronary Syndromes (ACS)

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.

John Batsis, MD principal investigator

UNC Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty, run by University of North Carolina, Chapel Hill at 1 site 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 3 inclusion and 9 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 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 blood sample (time frame: Up to 12 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05581082.

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 25 Jun 2024.