Pulmonary HypertensionNCT05447390
Evaluation of the Strength of Handgrip in Patients With Pulmonary Artery Hypertension
A study testing Handgrip strength test in people with Pulmonary Hypertension, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Handgrip strength test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 1 Jun 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Volunteers' Rejection Criteria:
- Younger than 5 years.
- Mental state disorders which will cause inaccuracies in the study's
- Volunteers' Dismissal Criteria:
- Inadaptation to the study's steps.
- If subjects become reluctant to continue with the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University School of Medicine
Ankara, 06560
About this study
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).
Read more
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
Read the 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
- Conditions
- Pulmonary Hypertension
- Being tested
- Handgrip strength test
- Keywords
- handgrip, functional status
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handgrip strength testDiagnostic test
The Jamar Hydraulic Hand Dynamometer device is used for measuring the handgrip strength test
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Hypertension | Active comparator | Not described Receives: Diagnostic Test: Handgrip strength test |
| Healthy Control | Active comparator | Not described Receives: Diagnostic Test: Handgrip strength test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Sep 2020
- Primary completion1 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Kula, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447390
- Sponsor's protocol ID
- 2022-397
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31495407Kula 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.
PubMed 28425226Di 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.
PubMed 2995236Neidenbach 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.
PubMed 31737527Mathiowetz 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.
PubMed 3777107Hager-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.
PubMed 12162590Ploegmakers 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.
PubMed 24287219
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Strength of Handgrip in Patients With Pulmonary Artery Hypertension
- ClinicalTrials.gov ID
- NCT05447390
- Acronym / sponsor ID
- 2022-397
- Conditions
- Pulmonary Hypertension
- Keywords
- handgrip, functional status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 7 Jul 2022 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Hypertension | Active comparator | Diagnostic Test: Handgrip strength test |
| Healthy Control | Active comparator | Diagnostic Test: Handgrip strength test |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- Younger than 5 years.
- Mental state disorders which will cause inaccuracies in the study's
- Inadaptation to the study's steps.
- If subjects become reluctant to continue with the study.
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 |
|---|---|---|
| Handgrip strength testThe Jamar Hydraulic Hand Dynamometer device is used for measuring the handgrip strength test | Diagnostic test | Healthy Control, Pulmonary Hypertension |
Primary outcome
Evaluation of the strength of handgrip in patients with pulmonary artery hypertension
Time frame: Baseline
Investigate and evaluate of the strength of handgrip in patients with pulmonary artery hypertension with hand dynamometer compared to healthy individuals.
1 secondary outcome
Evaluation of the strength of handgrip in patients with pulmonary artery hypertension
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Background: PubMed 31495407Hansmann 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.
- Background: PubMed 28425226Kula 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.
- Background: PubMed 2995236Di 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.
- Background: PubMed 31737527Neidenbach 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.
- Background: PubMed 3777107Mathiowetz 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.
- Background: PubMed 12162590Hager-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.
- Background: PubMed 24287219Ploegmakers 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handgrip strength test in people with Pulmonary Hypertension, run by Gazi University 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Jul 2022. 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?
Results are not available in the source record.
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?
Evaluation of the strength of handgrip in patients with pulmonary artery hypertension (time frame: Baseline). 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 NCT05447390, which also lists 7 linked publications.
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 7 Jul 2022.