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Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism

NCT ID: NCT03713671

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-17

Study Completion Date

2023-08-27

Brief Summary

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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

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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.

Conditions

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Primary Hyperparathyroidism

Keywords

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Primary Hyperparathyroidism Spatio-Temporal Parameters of Gait Gait Symmetry Balance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PHPT Group

Spatio-Temporal gait analysis and balance assessment of subjects with Primary Hyperparathyroidism

Group Type OTHER

gait analysis

Intervention Type DIAGNOSTIC_TEST

Computerized gait analysis system will use to evaluate spatio-temporal gait parameters

Control Group

Spatio-Temporal gait analysis and balance assessment of healthy subjects

Group Type OTHER

gait analysis

Intervention Type DIAGNOSTIC_TEST

Computerized gait analysis system will use to evaluate spatio-temporal gait parameters

Interventions

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gait analysis

Computerized gait analysis system will use to evaluate spatio-temporal gait parameters

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role collaborator

Ankara Education and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Recep Tayyip Erdogan University Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Melek Merve ERDEM

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melek M. ERDEM

Role: PRINCIPAL_INVESTIGATOR

Tayyip Erdogan University Training and Research Hospital

Gonul KOC, MD

Role: STUDY_DIRECTOR

Ankara Education and Research Hospital

Semra TOPUZ, Assoc. Prof.

Role: STUDY_DIRECTOR

Hacettepe University

Mikail K. DEMIREL, MD

Role: STUDY_CHAIR

Ankara Education and Research Hospital

Cavit CULHA, Assoc. Prof.

Role: STUDY_CHAIR

Ankara Education and Research Hospital

Locations

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Ankara Education and Research Hospital

Ankara, Cankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 25646406 (View on PubMed)

Other Identifiers

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GO 18/790

Identifier Type: -

Identifier Source: org_study_id