Parathyroidectomy and Mobility Study

Not yet recruiting

• Conditions: Hyperparathyroidism; Parathyroid; Mobility

• Registration Number: NCT07103876
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-21
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05
• Study Start: 2025-08-15
• Primary Completion: 2026-11
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distance Walked in Six-Minute Walk Test (6MWT)	At pre-operative assessment and at 3 month post-operative assessment	Measures walking endurance and aerobic capacity by recording the distance walked in six minutes along a 20-meter course.
Short Physical Performance Battery Score	At pre-operative assessment and at 3 month post-operative assessment	A composite test assessing balance, gait speed (4-meter walk), and lower body strength (chair stands). Higher scores reflect better function.
Isokinetic Knee Strength (Biodex)	At pre-operative assessment and at 3 month post-operative assessment	Assesses lower limb muscle strength and endurance using a dynamometer. Reports peak torque and fatigue index.
Grip Strength	At pre-operative assessment and at 3 month post-operative assessment	Handgrip strength is measured using a dynamometer as a marker of overall muscle strength and frailty risk.
Intensity of Movement using ActiGraph Accelerometry	At pre-operative assessment and at 3 month post-operative assessment	An objective measure of free-living physical activity using a wearable hip device that captures intensity of movement over 7 days.
Frequency of Movement using ActiGraph Accelerometry	At pre-operative assessment and at 3 month post-operative assessment	An objective measure of free-living physical activity using a wearable hip device that captures frequency of movement over 7 days.
Duration of Movement using ActiGraph Accelerometry	At pre-operative assessment and at 3 month post-operative assessment	An objective measure of free-living physical activity using a wearable hip device that captures duration of movement over 7 days.
CHAMPS Questionnaire Score	At pre-operative assessment and at 3 month post-operative assessment	A validated self-report tool for older adults that measures weekly frequency and duration of common physical activities.
Pasieka Parathyroidectomy Assessment of Symptoms (PAS)	At pre-operative assessment and at 3 month post-operative assessment	A validated 13-item questionnaire measuring severity of neurocognitive and neuromuscular symptoms common in PHPT, such as fatigue, irritability, and memory loss.
Concentration of Plasma Cytokine Biomarkers	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	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.

Trial Locations

Locations (1)

Clinical and Translational Research Building; 🇺🇸 Gainesville, Florida, United States