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.
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
OBSERVATIONAL
Enrollment
18
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.
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 weeks