Evaluation of the Strength of Handgrip in Patients With Pulmonary Artery Hypertension

NCT ID: NCT05447390

Last Updated: 2022-07-07

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-06-01

Brief Summary

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Our study aims to investigate the changes in muscle strength and muscle mass in PAH patients compared to healthy individuals and determine its effects on prognosis.

Further categorization of PAH patients based on their NYHA class will help determine if their handgrip strength decreases while progressing from NYHA class 1 to 4. This in turn allows us to examine if the handgrip test can be considered as an alternative to a 6-minute walking test (6MWT).

The Jamar Hydraulic Hand Dynamometer device in our hospital is used for measuring the handgrip strength test.

The data of the included subjects in this study are obtained and recorded from the existing files. Also, the handgrip strength test data will be recorded after the investigation

Detailed Description

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In our study, dynamometer tests will be applied to approximately 15 patients diagnosed with PAH. For control purposes, a hand dynamometer test will be applied to 40 healthy children. Patients' age, gender, weight, height, NYHA class, used medications, complete blood count (Hb, Hct, MCV, RDW), BNP, Troponin-t, biochemical parameters, catheterization findings at diagnosis, Echocardiographic findings (Tricuspid Annular Plane Systolic Excursion-TAPSE), Right Ventricular End Systolic Remodeling Index (RVES-RI), Pulmonary Artery acceleration Time (PAaccT), Tricuspid Velocity Time Integral (TR-VTI), RV area, RV length, Right Ventricular Load Adaptation Index (RV LAI), congenital heart disease and whether there is a shunt recorded or not. Patients are informed about the test before the dynamometer test. This may affect the integrity and accuracy of test results. To prevent such inaccuracies, the test will be performed on patients' both hands and the results are not recorded. Patients are asked to sit in a specific position. That is to sit upright with their elbows flexed 90° and the palms facing inwards (medially). Then, the test is performed 3 times with both hands. The results are recorded as the average of all the trials for dominant and non-dominant hands separately. The length of patients' hands is also measured. With the help of this test,it is possible to measure the difference in handgrip strength between healthy subjects and PAH patients. Additionally, patients are divided into 4 groups based on their NYHA classes. This will investigate if the patients' handgrip strength decreases as progress from NYHA class 1 to 4

Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This study includes 15 patients diagnosed with Pulmonary Hypertension in Gazi Medical School Hospital Department of Pediatric Cardiology and 40 healthy children who applied to Gazi University Medical School Pediatric Cardiology Clinic
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pulmonary Hypertension

Group Type ACTIVE_COMPARATOR

Handgrip strength test

Intervention Type DIAGNOSTIC_TEST

The Jamar Hydraulic Hand Dynamometer device is used for measuring the handgrip strength test

Healthy Control

Group Type ACTIVE_COMPARATOR

Handgrip strength test

Intervention Type DIAGNOSTIC_TEST

The Jamar Hydraulic Hand Dynamometer device is used for measuring the handgrip strength test

Interventions

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Handgrip strength test

The Jamar Hydraulic Hand Dynamometer device is used for measuring the handgrip strength test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Pulmonary Hypertension Group:

* Diagnosed with Pulmonary Hypertension and attending the clinic for follow-ups.
* Older than 5 years.

Healthy Control Group

* Individuals without any known diseases, structural Cardiac anomalies, familial history of heart diseases and sudden death.
* Older than 5 years.

Exclusion Criteria

Volunteers' Rejection Criteria:

* Younger than 5 years.
* Mental state disorders which will cause inaccuracies in the study's

i. Volunteers' Dismissal Criteria:
* Inadaptation to the study's steps.
* If subjects become reluctant to continue with the study.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Serdar Kula

M.D, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gazi University School of Medicine

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Hansmann G, Koestenberger M, Alastalo TP, Apitz C, Austin ED, Bonnet D, Budts W, D'Alto M, Gatzoulis MA, Hasan BS, Kozlik-Feldmann R, Kumar RK, Lammers AE, Latus H, Michel-Behnke I, Miera O, Morrell NW, Pieles G, Quandt D, Sallmon H, Schranz D, Tran-Lundmark K, Tulloh RMR, Warnecke G, Wahlander H, Weber SC, Zartner P. 2019 updated consensus statement on the diagnosis and treatment of pediatric pulmonary hypertension: The European Pediatric Pulmonary Vascular Disease Network (EPPVDN), endorsed by AEPC, ESPR and ISHLT. J Heart Lung Transplant. 2019 Sep;38(9):879-901. doi: 10.1016/j.healun.2019.06.022. Epub 2019 Jun 21.

Reference Type BACKGROUND
PMID: 31495407 (View on PubMed)

Kula S, Pektas A. A review of pediatric pulmonary hypertension with new guidelines. Turk J Med Sci. 2017 Apr 18;47(2):375-380. doi: 10.3906/sag-1605-172.

Reference Type BACKGROUND
PMID: 28425226 (View on PubMed)

Di Rienzo A, Felicetti L, Novelletto A, Forteleoni G, Colombo B. Frequency and types of deletional alpha+-thalassemia in northern Sardinia. Hum Genet. 1985;71(2):147-9. doi: 10.1007/BF00283371.

Reference Type BACKGROUND
PMID: 2995236 (View on PubMed)

Neidenbach RC, Oberhoffer R, Pieper L, Freilinger S, Ewert P, Kaemmerer H, Nagdyman N, Hager A, Muller J. The value of hand grip strength (HGS) as a diagnostic and prognostic biomarker in congenital heart disease. Cardiovasc Diagn Ther. 2019 Oct;9(Suppl 2):S187-S197. doi: 10.21037/cdt.2019.09.16.

Reference Type BACKGROUND
PMID: 31737527 (View on PubMed)

Mathiowetz V, Wiemer DM, Federman SM. Grip and pinch strength: norms for 6- to 19-year-olds. Am J Occup Ther. 1986 Oct;40(10):705-11. doi: 10.5014/ajot.40.10.705.

Reference Type BACKGROUND
PMID: 3777107 (View on PubMed)

Hager-Ross C, Rosblad B. Norms for grip strength in children aged 4-16 years. Acta Paediatr. 2002;91(6):617-25. doi: 10.1080/080352502760068990.

Reference Type BACKGROUND
PMID: 12162590 (View on PubMed)

Ploegmakers JJ, Hepping AM, Geertzen JH, Bulstra SK, Stevens M. Grip strength is strongly associated with height, weight and gender in childhood: a cross sectional study of 2241 children and adolescents providing reference values. J Physiother. 2013 Dec;59(4):255-61. doi: 10.1016/S1836-9553(13)70202-9.

Reference Type BACKGROUND
PMID: 24287219 (View on PubMed)

Other Identifiers

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2022-397

Identifier Type: -

Identifier Source: org_study_id

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