Clinical trial NCT03713671: Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism
Official title: The Effect of Quadriceps Femoris Muscle Fatigue Protocol on Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Hyperparathyroidism
Keywords: Primary Hyperparathyroidism
Spatio-Temporal Parameters of Gait
Gait Symmetry
Balance
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Hacettepe University
name: Ankara Education and Research Hospital
First posted: 2018-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SCREENING

Brief summary: This study will evaluate how Quadriceps Femoris muscle fatigue protocol affect the spatio-temporal gait parameters, gait symmetry and balance in individuals with primary hyperparathyroidism before and after parathyroidectomy. Study group will consist of 20 subjects with primary hyperparathyroidism (PHPT) and control group will consist of 20 healthy subjects.

Detailed description: Parathyroid hormone, released from the parathyroid gland, plays an important role in keeping the ionized calcium in between the reference values in body. Precise control of ionized calcium is particularly necessary to ensure the optimal function of physiological processes such as providing intracellular signaling, performing neuromuscular functions and bone metabolism. When there is a decrease in the level of ionized calcium in the systemic circulation due to any reason, increased calcium concentration is maintained as a result of the increased absorption of calcium from the kidneys, bones and intestines into the blood via increased parathyroid hormone. An error caused by any of the components in this regulatory system may cause excessive parathyroid hormone release, causing primary, secondary or tertiary hyperparathyroidism. Primary hyperparathyroidism (PHPT) is a common endocrinological disorder, which is characterized by excessive release of parathyroid hormone, resulting in a defect in the regulation of calcium metabolism. PHPT, is the third most common endocrine disease and is the most common cause of hypercalcemia. Today, PHPT is approximately 0.25-0.66% of the population and it is seen as 3: 1 times more common in women than men. While the incidence of the disease increases with age, it increases dramatically after 50 years of age. The clinical presentation of PHPT ranges from asymptomatic disease to the classical symptomatic disease of renal and / or musculoskeletal complications. Low plasma 25 Hydroxyvitamin D level; bone mineral density, muscle strength, preservation of postural stability and functional performance of the musculoskeletal functions such as disruption caused by the person's walking and balance activities are adversely affected.In addition, fatigue, pain, and body mass index, as a result of the increase in the functional capacity of the person is seriously reduced quality of life and psychosocial status is adversely affected. Although there are studies related to bone mineral density, muscle strength and function, instability, fatigue, etc., which are secondary to PHPT and cause a significant decrease in functional capacity, there is no study to investigate the effect of M. quadriceps Femoris ,which has a key role in the evaluation of functional capacity, muscle fatigue on the gait and balance parameters in the pre and post-treatment period in the literature. The aim of this case-control study is to investigate the effect of Quadriceps Femoris muscle fatigue protocol on gait, gait symmetry and balance parameters before and after parathyroidectomy in patients PHPT and to compare that parameters of these individuals with healthy controls with similar demographic characteristics that included in the control group.

Eligibility criteria: Inclusion Criteria:

* PHPT group, include cases with a Primary Hyperparathyroidism
* Control group consists of healthy adults with the similar demographic characteristics as study group.

Exclusion Criteria:

* The presence of osteoarticular deformities
* Walking with assist device
* Having a neurological disease that may affect the performance
* To have significant and irreversible visual deficits
* The body mass index (BMI) is greater than\> 40 kg / m²
* There is an inability to prevent any of the tests
* Individuals with cancer history and chemotherapy (over the last 5 years)
* Plasma creatinine level\> 150 µmol / L
* Use of Cinacalcet or Etalpha
* Having a history of diabetes mellitus

Primary outcomes:
measure: Step Length
timeFrame: 1 week
Secondary outcomes:
measure: Stride Length
timeFrame: 1 week
measure: Static Balance Assessment
timeFrame: 1 week
measure: Dynamic Balance Assessment
timeFrame: 1 week
measure: Fatigue Severity
timeFrame: 1 week
measure: Functional Capacity
timeFrame: 1 week
measure: Step Width
timeFrame: 1 week
measure: Foot Progression Angle
timeFrame: 1 week
measure: Speed
timeFrame: 1 week
measure: Cadence
timeFrame: 1 week
measure: Percentage of Double Support
timeFrame: 1 week
measure: Percentage of Stance
timeFrame: 1 week
measure: Percentage of Swing
timeFrame: 1 week
measure: Gait Symmetry
timeFrame: 1 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Education and Research Hospital
state: Cankaya
Study officials:
affiliation: Tayyip Erdogan University Training and Research Hospital
name: Melek M. ERDEM
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Education and Research Hospital
name: Gonul KOC, MD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Semra TOPUZ, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Ankara Education and Research Hospital
name: Mikail K. DEMIREL, MD
role: STUDY_CHAIR
affiliation: Ankara Education and Research Hospital
name: Cavit CULHA, Assoc. Prof.
role: STUDY_CHAIR
References:
citation: Rolighed L, Rejnmark L, Sikjaer T, Heickendorff L, Vestergaard P, Mosekilde L, Christiansen P. No beneficial effects of vitamin D supplementation on muscle function or quality of life in primary hyperparathyroidism: results from a randomized controlled trial. Eur J Endocrinol. 2015 May;172(5):609-17. doi: 10.1530/EJE-14-0940. Epub 2015 Feb 2.