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

The Effect of Quadriceps Femoris Muscle Fatigue Protocol on Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism

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.

Study Overview

• Status: Completed
• Conditions: Primary Hyperparathyroidism
• Intervention / Treatment: Diagnostic test: gait analysis

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melek M. ERDEM, PT, M.Sc.; Phone Number: +905300659539; Email: melekmerve.erdem@erdogan.edu.tr
• Study Contact Backup: Name: Gonul KOC, MD; Phone Number: +905057711757; Email: gonulkoc08@hotmail.com

Study Locations

• Turkey
  • Cankaya
    • Ankara, Cankaya, Turkey, 06100
      • Ankara Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PHPT Group; Spatio-Temporal gait analysis and balance assessment of subjects with Primary Hyperparathyroidism	Diagnostic test: gait analysis; Computerized gait analysis system will use to evaluate spatio-temporal gait parameters
Other: Control Group; Spatio-Temporal gait analysis and balance assessment of healthy subjects	Diagnostic test: gait analysis; Computerized gait analysis system will use to evaluate spatio-temporal gait parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step Length	It is measured along the length of the walkway, from the heel center of the current footprint to the heel center of the previous footprint on the opposite foot.The unit of measure is centimeters.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stride Length	It is measured on the line of progression between the heel points of two consecutive footprints of the same foot (left to left, right to right). The unit of measure is centimeters.	1 week
Static Balance Assessment	The Romberg test will use to assessment for diagnose sensory ataxia, a gait disturbance caused by abnormal proprioception involving information about the location of the joints. The Static Balance Assessment of the individuals in the PHPT group were assessed before and 3 months after Parathyroidectomy.	1 week
Dynamic Balance Assessment	To determine fall risk and measure the progress of balance, sit to stand, and walking Timed Up and Go Test will use. The Dynamic Balance Assessment of the individuals in the PHPT group were assessed before and 3 months after Parathyroidectomy.	1 week
Fatigue Severity	The fatigue level that individuals perceived during the performance was recorded using the Fatigue Severity Scale. This is a nine-items questionnaire that assesses the effect of fatigue on daily living. Each item is a statement on fatigue that the subject rates from 1, ' strongly disagree ' to 7, ' strongly agree '.	1 week
Functional Capacity	6 Minute Walk test was used to evaluate the functional capacity. The test was performed in a corridor on a flat hard surface of 30 m in length in a straight line. Before the examination, the patient rested for 10 min in a sitting position. It is calculated by measuring the distance that the person walks at the end of this period by asking the person to walk for 6 minutes along a 30 m corridor. In cases of chest pain, dyspnea, leg cramps, excessive fatigue, sweating and wilting, the test should be terminated immediately. The clinician supervising the test instructed the subject on the walking technique and the possibility of taking a rest. At one-minute intervals during the test, the participant received information about the time remaining until the end of the test.	1 week
Step Width	It is measured from the midline midpoint of the current footprint to the midline midpoint of the previous footprint on the opposite foot.The unit of measure is centimeters.	1 week
Foot Progression Angle	It is the angle between the line of progression and the midline of the footprint. This angle is zero if the geometric mid- line of the footprint is parallel to the line of progression; positive, toe-out, when the mid-line of the footprint is outside the line of progression and negative, toe-in, when inside the line of progression. The unit of measure is degrees.	1 week
Speed	It is obtained after dividing the distance traveled by the ambulation time. It is expressed in centimeters per second (cm/sec)	1 week
Cadence	The rate at which a person walk, expressed in steps per minute (step/min). The average cadence is 100 - 115 steps/min.	1 week
Percentage of Double Support	It is the amount of time that a person spends with both feet on the ground during one gait cycle. It is presented as a percentage of the gait cycle time (% gait cycle). The percentage of time spent in double support decreases as the speed of walking increases.	1 week
Percentage of Stance	The stance phase is the weight bearing portion of each gait cycle. It is initiated by heel contact and ends with toe off of the same foot. It is the time elapsed between the first contact and the last contact of two consecutive footfalls on the same foot. It is also presented as a percentage of the gait cycle time (% gait cycle)	1 week
Percentage of Swing	It is initiated with toe off and ends with heel strike. It is the time elapsed between the last contact of the current footfall to the first contact of the next footfall on the same foot. It is expressed in seconds (sec) and it is also presented as a percent of the gait cycle (% gait cycle) of the same foot. The Swing Time is equal to the Single Support time of the opposite foot.	1 week
Gait Symmetry	It's calculated in order to evaluate symmetry and bilateral coordination of gait. The Symmetry Index and Symmetry Angle are interpreted as a complete symmetry if the result is 0. Evaluation of asymmetries observed in the spatio-temporal characteristics, a deviation of at least 10% from the 0 value for exact symmetry.	1 week

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital
• Collaborators: Hacettepe University; Ankara Education and Research Hospital
• Investigators: Principal Investigator: Melek M. ERDEM, Tayyip Erdogan University Training and Research Hospital; Study Director: Gonul KOC, MD, Ankara Education and Research Hospital; Study Chair: Mikail K. DEMIREL, MD, Ankara Education and Research Hospital; Study Chair: Cavit CULHA, Assoc. Prof., Ankara Education and Research Hospital; Study Director: Semra TOPUZ, Assoc. Prof., Hacettepe University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2021
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): August 27, 2023

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Primary Hyperparathyroidism; Spatio-Temporal Parameters of Gait; Gait Symmetry; Balance
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary
• Other Study ID Numbers: GO 18/790

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months with completion of the result report.
• IPD Sharing Access Criteria: Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No