Primary HyperparathyroidismNCT03713671
Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism
A study testing gait analysis in people with Primary Hyperparathyroidism, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Hyperparathyroidism
- What is being tested?
- gait analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Oct 2021to 27 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PHPT group, include cases with a Primary Hyperparathyroidism
- Control group consists of healthy adults with the similar demographic characteristics as study group.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Education and Research Hospital
Ankara, Cankaya, 06100
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Hyperparathyroidism
- Being tested
- gait analysis
- Keywords
- Primary Hyperparathyroidism, Spatio-Temporal Parameters of Gait, Gait Symmetry, Balance
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait analysisDiagnostic test
Computerized gait analysis system will use to evaluate spatio-temporal gait parameters
| Study group | Role | What they receive |
|---|---|---|
| PHPT Group | Other | Spatio-Temporal gait analysis and balance assessment of subjects with Primary Hyperparathyroidism Receives: Diagnostic Test: gait analysis |
| Control Group | Other | Spatio-Temporal gait analysis and balance assessment of healthy subjects Receives: Diagnostic Test: gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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 '.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week
Speed
It is obtained after dividing the distance traveled by the ambulation time. It is expressed in centimeters per second (cm/sec)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start17 Oct 2021
- Primary completion15 May 2023
- Study completion27 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University, Ankara Education and Research Hospital
- Responsible party
- Principal investigator, Melek Merve ERDEM, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Melek M. ERDEM, Principal investigator, Tayyip Erdogan University Training and Research HospitalGonul KOC, MD, Study director, Ankara Education and Research HospitalSemra TOPUZ, Assoc. Prof., Study director, Hacettepe UniversityMikail K. DEMIREL, MD, Study chair, Ankara Education and Research HospitalCavit CULHA, Assoc. Prof., Study chair, Ankara Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713671
- Sponsor's protocol ID
- GO 18/790
- Status last verified
- Dec 2023
- First submitted
- 18 Oct 2018
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
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.
PubMed 25646406
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Quadriceps Femoris Muscle Fatigue Protocol on Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT03713671
- Acronym / sponsor ID
- GO 18/790
- Conditions
- Primary Hyperparathyroidism
- Keywords
- Primary Hyperparathyroidism, Spatio-Temporal Parameters of Gait, Gait Symmetry, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Collaborators
- Hacettepe University, Ankara Education and Research Hospital
- Study start
- 17 Oct 2021 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 27 Aug 2023 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| PHPT Group | Other | Diagnostic Test: gait analysisSpatio-Temporal gait analysis and balance assessment of subjects with Primary Hyperparathyroidism |
| Control Group | Other | Diagnostic Test: gait analysisSpatio-Temporal gait analysis and balance assessment of healthy subjects |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PHPT group, include cases with a Primary Hyperparathyroidism
- Control group consists of healthy adults with the similar demographic characteristics as study group.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gait analysisComputerized gait analysis system will use to evaluate spatio-temporal gait parameters | Diagnostic test | Control Group, PHPT Group |
Primary outcome
Step Length
Time frame: 1 week
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.
13 secondary outcomes
Stride Length
Time frame: 1 week
Static Balance Assessment
Time frame: 1 week
Dynamic Balance Assessment
Time frame: 1 week
Fatigue Severity
Time frame: 1 week
Functional Capacity
Time frame: 1 week
Step Width
Time frame: 1 week
Foot Progression Angle
Time frame: 1 week
Speed
Time frame: 1 week
Cadence
Time frame: 1 week
Percentage of Double Support
Time frame: 1 week
Percentage of Stance
Time frame: 1 week
Percentage of Swing
Time frame: 1 week
Gait Symmetry
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 25646406Rolighed 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
Related trials for Primary Hyperparathyroidism
RecruitingObservational study
Natural History Study of Parathyroid Disorders
Parathyroid Cancer, Primary Hyperparathyroidism
Not yet recruiting
Treating PHPT With the nPulse™ Vybrance™ PE System
Primary Hyperparathyroidism
RecruitingEarly Phase 1
Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas
Hyperparathyroidism
RecruitingPhase 2/3
Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
Primary Hyperparathyroidism, Parathyroid Cancer
Enrolling by invitationObservational study
Parathyroid Adenoma Detection With Rubidium-82 Imaging
Parathyroid Adenomas, Hyperparathyroidism, Primary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melek M. ERDEM principal investigator
Tayyip Erdogan University Training and Research Hospital
Gonul KOC, MD study director
Ankara Education and Research Hospital
Semra TOPUZ, Assoc. Prof. study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gait analysis in people with Primary Hyperparathyroidism, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step Length (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03713671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.