NCT05447390

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

2.7 years

First QC Date

June 28, 2022

Last Update Submit

July 1, 2022

Conditions

Keywords

handgripfunctional status

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the strength of handgrip in patients with pulmonary artery hypertension

    Investigate and evaluate of the strength of handgrip in patients with pulmonary artery hypertension with hand dynamometer compared to healthy individuals.

    Baseline

Secondary Outcomes (1)

  • Evaluation of the strength of handgrip in patients with pulmonary artery hypertension

    Baseline

Study Arms (2)

Pulmonary Hypertension

ACTIVE COMPARATOR
Diagnostic Test: Handgrip strength test

Healthy Control

ACTIVE COMPARATOR
Diagnostic Test: Handgrip strength test

Interventions

Handgrip strength testDIAGNOSTIC_TEST

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

Healthy ControlPulmonary Hypertension

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University School of Medicine

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 31495407BACKGROUND
  • 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.

    PMID: 28425226BACKGROUND
  • 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.

    PMID: 2995236BACKGROUND
  • 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.

    PMID: 31737527BACKGROUND
  • 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.

    PMID: 3777107BACKGROUND
  • 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.

    PMID: 12162590BACKGROUND
  • 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.

    PMID: 24287219BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Professor

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 7, 2022

Study Start

September 1, 2020

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

July 7, 2022

Record last verified: 2022-07

Locations