Evaluation of the Strength of Handgrip in Patients With Pulmonary Artery Hypertension
Primary Purpose
Pulmonary Hypertension
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Handgrip strength test
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Hypertension focused on measuring handgrip, functional status
Eligibility Criteria
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.
Sites / Locations
- Gazi University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pulmonary Hypertension
Healthy Control
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Evaluation of the strength of handgrip in patients with pulmonary artery hypertension
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05447390
Brief Title
Evaluation of the Strength of Handgrip in Patients With Pulmonary Artery Hypertension
Official Title
Evaluation of the Strength of Handgrip in Patients With Pulmonary Artery Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
handgrip, functional status
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Hypertension
Arm Type
Active Comparator
Arm Title
Healthy Control
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Handgrip strength test
Intervention Description
The Jamar Hydraulic Hand Dynamometer device is used for measuring the handgrip strength test
Primary Outcome Measure Information:
Title
Evaluation of the strength of handgrip in patients with pulmonary artery hypertension
Description
Investigate and evaluate of the strength of handgrip in patients with pulmonary artery hypertension with hand dynamometer compared to healthy individuals.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Evaluation of the strength of handgrip in patients with pulmonary artery hypertension
Description
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).
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Gazi University School of Medicine
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31495407
Citation
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Results Reference
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PubMed Identifier
28425226
Citation
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.
Results Reference
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PubMed Identifier
2995236
Citation
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Results Reference
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PubMed Identifier
31737527
Citation
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.
Results Reference
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PubMed Identifier
3777107
Citation
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.
Results Reference
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PubMed Identifier
12162590
Citation
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.
Results Reference
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PubMed Identifier
24287219
Citation
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.
Results Reference
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Evaluation of the Strength of Handgrip in Patients With Pulmonary Artery Hypertension
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