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

Not Applicable

• Conditions: Pulmonary Hypertension
• Interventions: Diagnostic Test: Handgrip strength test

• Registration Number: NCT05447390
• Lead Sponsor: Gazi University

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

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2022-06-28
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-01
• Last Update Submitted: 2022-07-01
• Study First Posted: 2022-07-07
• Last Update Posted: 2022-07-07
• Primary Completion: 2023-05-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Control	Handgrip strength test	-
Pulmonary Hypertension	Handgrip strength test	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluation of the strength of handgrip in patients with pulmonary artery hypertension	Baseline	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).

Trial Locations

Locations (1)

Gazi University School of Medicine; 🇹🇷 Ankara, Turkey