Rescuing Mobility Function Through Surgical Removal of the Parathyroid Gland
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Distance Walked in Six-Minute Walk Test (6MWT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years;
- •Biochemical diagnosis of hypercalcemic (corrected serum calcium >10.2 mg/dL or ionized serum calcium >1.31 mmol/dL or 5.2 mg/dL on at least one serum sample) primary hyperparathyroidism as determined by board-certified endocrinologist or endocrine surgeon;
- •Undergoing parathyroidectomy at UF Health;
- •Willing and able to give informed consent.
排除标准
- •Failure to provide informed consent;
- •Biochemical diagnosis of eucalcemic primary hyperparathyroidism (corrected serum calcium ≤10.2 mg/dL or ionized serum calcium ≤1.31 mmol/dL or 5.2 mg/dL on at least one serum sample);
- •Elected not to undergo parathyroidectomy at UF Health;
- •Major surgery as deemed by principal investigator or hip/knee replacement in the past 6 months;
- •Fractures to the hands, arms or legs within the last 6 months;
- •Traumatic accident (i.e. motor vehicle collision, fall from elevation, etc.) resulting in orthopedic trauma or requiring prolonged immobilization (>2 weeks) within the last 6 months;
- •Blood transfusion within the past 3 months;
- •Self-reported myocardial infarction, cerebrovascular accident, or unstable angina within the past 6 months;
- •NYHA Class 3 or 4 congestive heart failure;
- •Major psychiatric disorder;
- •Cancer requiring treatment in the past 1 year (including metastatic cancer), except for locally treated non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer);
- •Renal failure requiring hemodialysis or peritoneal dialysis
- •Use of bone-modifying therapies (alendronate [Fosamax], zoledronic acid [Reclast], denosumab [Prolia or Xgeva], or romosozumab [Evenity]) within 1 month of planned surgery
- •Planning to permanently leave the area within 3 months of parathyroidectomy;
- •Vision or hearing impairment - defined as unable to read or listen/follow instructions despite the use of maximal assistive devices (i.e. contact lenses, glasses, hearing aids, etc.)
- •Participating in another clinical trial or has received an investigational product within 30 days prior to screening/enrollment.
研究组 & 干预措施
Adults aged 60 and above with primary hyperparathyroidism
Participants who are undergoing a parathyroidectomy at UF health
结局指标
主要结局
Distance Walked in Six-Minute Walk Test (6MWT)
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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.
Distance Walked in Six-Minute Walk Test (6MWT)
时间窗: 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
时间窗: 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)
时间窗: 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.
Intensity of Movement using ActiGraph Accelerometry
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点