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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG028740 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This study evaluates whether surgical removal of the parathyroid gland (parathyroidectomy) improves physical function and mobility in older adults with primary hyperparathyroidism (PHPT). PHPT, a common endocrine disorder in older adults, is associated with reduced muscle strength, mobility, and quality of life. This prospective observational study will enroll up to 80 participants aged 60 and older undergoing parathyroidectomy at UF Health. Participants will complete physical performance tests, wear an Actigraph device to assess physical activity, and provide blood samples for biomarker analysis at pre- and post-operative time points. The goal is to characterize changes in physical function and activity following surgery and to identify biomarkers that may predict mobility improvements. Findings will help inform future larger-scale studies and could expand surgical indications for PHPT in older adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults aged 60 and above with primary hyperparathyroidism | Participants who are undergoing a parathyroidectomy at UF health |
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| Measure | Description | Time Frame |
|---|---|---|
| Distance Walked in Six-Minute Walk Test (6MWT) | Measures walking endurance and aerobic capacity by recording the distance walked in six minutes along a 20-meter course. | At pre-operative assessment and at 3 month post-operative assessment |
| Short Physical Performance Battery Score | A composite test assessing balance, gait speed (4-meter walk), and lower body strength (chair stands). Higher scores reflect better function. | At pre-operative assessment and at 3 month post-operative assessment |
| Isokinetic Knee Strength (Biodex) | Assesses lower limb muscle strength and endurance using a dynamometer. Reports peak torque and fatigue index. | At pre-operative assessment and at 3 month post-operative assessment |
| Grip Strength | Handgrip strength is measured using a dynamometer as a marker of overall muscle strength and frailty risk. | At pre-operative assessment and at 3 month post-operative assessment |
| Intensity of Movement using ActiGraph Accelerometry | An objective measure of free-living physical activity using a wearable hip device that captures intensity of movement over 7 days. | At pre-operative assessment and at 3 month post-operative assessment |
| Frequency of Movement using ActiGraph Accelerometry | An objective measure of free-living physical activity using a wearable hip device that captures frequency of movement over 7 days. | At pre-operative assessment and at 3 month post-operative assessment |
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This study will enroll adults aged 60 years and older with a confirmed biochemical diagnosis of hypercalcemic primary hyperparathyroidism (PHPT) who are scheduled to undergo parathyroidectomy at UF Health. Eligible participants must be able and willing to provide informed consent and complete all study procedures, including pre- and post-operative physical assessments and blood draws.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nevena Stanojevic, Bachelor of Science | Contact | 352-273-5919 | nevenastanojevic@ufl.edu | |
| Aditya Shirali, MD | Contact | 352-265-0169 | aditya.shirali@surgery.ufl.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical and Translational Research Building | Recruiting | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
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Blood samples will be collected for plasma biomarker analysis (e.g., myokines, osteokines, and adipokines such as IL-6, myostatin, and FGF-21), as well as for standard clinical labs including calcium, parathyroid hormone (PTH), and vitamin D.
| Duration of Movement using ActiGraph Accelerometry | An objective measure of free-living physical activity using a wearable hip device that captures duration of movement over 7 days. | At pre-operative assessment and at 3 month post-operative assessment |
| CHAMPS Questionnaire Score | A validated self-report tool for older adults that measures weekly frequency and duration of common physical activities. | At pre-operative assessment and at 3 month post-operative assessment |
| Pasieka Parathyroidectomy Assessment of Symptoms (PAS) | A validated 13-item questionnaire measuring severity of neurocognitive and neuromuscular symptoms common in PHPT, such as fatigue, irritability, and memory loss. | At pre-operative assessment and at 3 month post-operative assessment |
| Concentration of Plasma Cytokine Biomarkers | Blood-based analysis of myokines (e.g., IL-6, myostatin, LIF, irisin), osteokines (e.g., IGF-1, FGF-21, osteocalcin), and adipokines (e.g., adiponectin, TNF-α) associated with muscle-organ crosstalk, inflammation, and mobility. | Blood work will be collected at the pre-operative assessment, the 2 week post-operative assessment, 3 month post-operative assessment and the 6 month post-operative assessment |