Huntington DiseaseNCT06585332
Handgrip and Respiratory Dysfunction in HD Patients.
An observational study of Huntington Disease, run by General University Hospital, Prague at 1 site in Czechia.
Trial summary
Hereditary neurodegenerative diagnosis of Huntington's disease (HD) is associated with a progressive deterioration of the respiratory system function . This fact contributes strongly to the increased risk of aspiration pneumonia as a primary cause of death in people with HD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Assessment of respiratory paramenters (Maximal inspiratory pressure, maximal expiratory pressure, and voluntary peak cough flow))
- How many people
- 70 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2024to 31 Oct 2024
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people with confirmed diagnosis of Huntington's disease
Who may be able to join
- Genetic confirmed diagnosis of Huntington's disease
Who cannot join
- diagnosis of other concomitant neurological diseases;
- a history of cardiovascular or lung disease;
- respiratory symptoms such as cough, phlegm, wheezing, or dyspnea at the time of assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hand Grip Strength As a Screening Tool for Respiratory Dysfunction in Huntington's Disease
Hereditary neurodegenerative diagnosis of Huntington's disease (HD) is associated with a progressive deterioration of the respiratory system function . This fact contributes strongly to the increased risk of aspiration pneumonia as a primary cause of death in people with HD. But regularly objective monitoring of the airway system condition is in common clinical practice almost impossible for high time requirements and the need for specialized expensive devices . This drives the need for a simpler and more cost-effective screening tool. In recent years published studies, working with all ages and genders, show correlation between hand grip strength (HGS) and respiratory parameters. As a second simple screening tool, we chose a short questionnaire called the Index of pulmonary dysfunction.
Read the detailed description
Goal: To identify a simple method for screening respiratory muscle and cough weakness in Huntington\'s Disease (HD) patients, suitable for clinical practice.
Hypothesis 1: Maximal inspiratory pressure, maximal expiratory pressure, and voluntary peak cough flow will be significantly correlated with maximal hand grip strength in HD patients.
Hypothesis 2: Maximal inspiratory pressure, maximal expiratory pressure, and voluntary peak cough flow will be significantly correlated with the Index of pulmonary dysfunction in HD patients.
- Conditions
- Huntington Disease
- Being tested
- Assessment of respiratory paramenters (Maximal inspiratory pressure, maximal expiratory pressure, and voluntary peak cough flow))
- Keywords
- Huntington Disease, Respiratory dysfunction, Peak cough flow, Handgrip strength, Screening tool
- Medical subject headings
- Huntington Disease, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of respiratory paramenters (Maximal inspiratory pressure, maximal expiratory pressure, and voluntary peak cough flow))Other
Also called Assessment of hand grip strength, Questionnaire: Index of pulmonary dysfunction
The voluntary peak cough flow is measured using a pneumotachograph (BTL cardiopoint Spiro, BTL industries), which meets the recommendations of the American Thoracic Society and the European Respiratory Society for range and accuracy in forced expiratory maneuvers.
Maximal expiratory and inspiratory pressures assessments were performed using a flanged rubber mouthpiece connected to a pressure manometer (Micro RPM, Vyaire Medical). Assessments are conducted according to the statements on respiratory muscle testing of the American Thoracic Society and the European Respiratory Society.
Hand grip strength Grip strength is measured using DHD-1 digital hand dynamometer (SAEHAN®,Seahan Corporation), assessment follows recommendation of The American Society of Hand Therapists.
| Study group | Role | What they receive |
|---|---|---|
| Persons with HD | One group - adult patients with genetically confirmed Huntington disease. Receives: Other: Assessment of respiratory paramenters (Maximal inspiratory pressure, maximal expiratory pressure, and voluntary peak cough flow)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Hand grip strength
Unit of Measure: kg Assessment followed recommendation of The American Society of Hand Therapists. HSG is measured using DHD-1 digital hand dynamometer (SAEHAN®,Seahan Corporation).
Measured: Up to 35 weeks (once on a single screening visit)
Voluntary peak cough flow
Unit of measure: l/min Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Measured: Up to 35 weeks (once on a single screening visit)
Maximal expiratory pressure, Maximal inspiratory pressure
Unite of measure: cmH2O Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Measured: Up to 35 weeks (once on a single screening visit)
Secondary outcomes (1)
Index of Pulmonary dysfunction
Questionnaire of four questions. Scale range: 0-11 points A higher score indicates a worse pulmonary condition.
Measured: Up to 35 weeks (once on a single screening visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start1 Apr 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romana Konvalinková, General University Hospital, Prague
- Investigators
- Romana Konvalinkova, MS, Principal investigator, General University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585332
- Sponsor's protocol ID
- HGS IPD Resp HD
- Status last verified
- Sep 2024
- First submitted
- 28 Aug 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones U, Busse M, Enright S, Rosser AE. Respiratory decline is integral to disease progression in Huntington's disease. Eur Respir J. 2016 Aug;48(2):585-8. doi: 10.1183/13993003.02215-2015. Epub 2016 Jun 23.
PubMed 27338194Reyes A, Cruickshank T, Ziman M, Nosaka K. Pulmonary function in patients with Huntington's disease. BMC Pulm Med. 2014 May 26;14:89. doi: 10.1186/1471-2466-14-89.
PubMed 24886346Schumann-Werner B, Dogan I, Mirzazade S, Mall B, Overbeck R, Honrath P, Schulz JB, Reetz K, Werner CJ. Clinical predictors and neural correlates for compromised swallowing safety in Huntington disease. Eur J Neurol. 2021 Sep;28(9):2855-2862. doi: 10.1111/ene.14953. Epub 2021 Jun 24.
PubMed 34077591Jakusova J, Brozmanova M. Methods of Cough Assessment and Objectivization. Physiol Res. 2023 Dec 31;72(6):687-700. doi: 10.33549/physiolres.935062.
PubMed 38215057Ohara DG, Pegorari MS, Oliveira Dos Santos NL, de Fatima Ribeiro Silva C, Monteiro RL, Matos AP, Jamami M. Respiratory Muscle Strength as a Discriminator of Sarcopenia in Community-Dwelling Elderly: A Cross-Sectional Study. J Nutr Health Aging. 2018;22(8):952-958. doi: 10.1007/s12603-018-1079-4.
PubMed 30272099Efstathiou ID, Mavrou IP, Grigoriadis KE. Correlation Between Maximum Inspiratory Pressure and Hand-Grip Force in Healthy Young and Middle-Age Individuals. Respir Care. 2016 Jul;61(7):925-9. doi: 10.4187/respcare.04319. Epub 2016 Apr 19.
PubMed 27094394Shin HI, Kim DK, Seo KM, Kang SH, Lee SY, Son S. Relation Between Respiratory Muscle Strength and Skeletal Muscle Mass and Hand Grip Strength in the Healthy Elderly. Ann Rehabil Med. 2017 Aug;41(4):686-692. doi: 10.5535/arm.2017.41.4.686. Epub 2017 Aug 31.
PubMed 28971054Bahat G, Tufan A, Ozkaya H, Tufan F, Akpinar TS, Akin S, Bahat Z, Kaya Z, Kiyan E, Erten N, Karan MA. Relation between hand grip strength, respiratory muscle strength and spirometric measures in male nursing home residents. Aging Male. 2014 Sep;17(3):136-40. doi: 10.3109/13685538.2014.936001. Epub 2014 Jul 4.
PubMed 24993454Enright PL, Kronmal RA, Manolio TA, Schenker MB, Hyatt RE. Respiratory muscle strength in the elderly. Correlates and reference values. Cardiovascular Health Study Research Group. Am J Respir Crit Care Med. 1994 Feb;149(2 Pt 1):430-8. doi: 10.1164/ajrccm.149.2.8306041.
PubMed 8306041Srp M, Bartosova T, Klempir J, Lagnerova R, Gal O, Listvanova T, Jech R, Ruzicka E, Hoskovcova M. Expiratory Muscle Strength Training in Multiple System Atrophy: A Pilot Study. Mov Disord Clin Pract. 2023 May 19;10(7):1060-1065. doi: 10.1002/mdc3.13765. eCollection 2023 Jul.
PubMed 37476315Smeltzer SC, Lavietes MH, Troiano R, Cook SD. Testing of an Index of Pulmonary Dysfunction in Multiple Sclerosis. Nurs Res. 1989 Nov-Dec;38(6):370-4.
PubMed 2587294Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
PubMed 30956204Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.
PubMed 21624928Konvalinkova R, Srp M, Doleckova K, Capek V, Gal O, Hoskovcova M, Klempir J. Handgrip strength and the Index of pulmonary dysfunction: Practical screening tools for cough dysfunction in huntington's disease. J Huntingtons Dis. 2026 Feb;15(1):148-155. doi: 10.1177/18796397251385607. Epub 2025 Oct 14.
PubMed 41332279
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Grip Strength As a Screening Tool for Respiratory Dysfunction in Huntington's Disease
- ClinicalTrials.gov ID
- NCT06585332
- Acronym / sponsor ID
- HGS IPD Resp HD
- Conditions
- Huntington Disease
- Keywords
- Huntington Disease, Respiratory dysfunction, Peak cough flow, Handgrip strength, Screening tool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 5 Sep 2024 (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.
Hereditary neurodegenerative diagnosis of Huntington's disease (HD) is associated with a progressive deterioration of the respiratory system function . This fact contributes strongly to the increased risk of aspiration pneumonia as a primary cause of death in people with HD. But regularly objective monitoring of the airway system condition is in common clinical practice almost impossible for high time requirements and the need for specialized expensive devices . This drives the need for a simpler and more cost-effective screening tool. In recent years published studies, working with all ages and genders, show correlation between hand grip strength (HGS) and respiratory parameters. As a second simple screening tool, we chose a short questionnaire called the Index of pulmonary dysfunction.
Detailed description
Goal: To identify a simple method for screening respiratory muscle and cough weakness in Huntington\'s Disease (HD) patients, suitable for clinical practice.
Hypothesis 1: Maximal inspiratory pressure, maximal expiratory pressure, and voluntary peak cough flow will be significantly correlated with maximal hand grip strength in HD patients.
Hypothesis 2: Maximal inspiratory pressure, maximal expiratory pressure, and voluntary peak cough flow will be significantly correlated with the Index of pulmonary dysfunction in HD patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with HD | – | Other: Assessment of respiratory paramenters (Maximal inspiratory pressure, maximal expiratory pressure, and voluntary peak cough flow))One group - adult patients with genetically confirmed Huntington disease. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people with confirmed diagnosis of Huntington's disease
Key inclusion criteria (1 listed)
- Genetic confirmed diagnosis of Huntington's disease
Key exclusion criteria (3 listed)
- diagnosis of other concomitant neurological diseases;
- a history of cardiovascular or lung disease;
- respiratory symptoms such as cough, phlegm, wheezing, or dyspnea at the time of assessment
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 |
|---|---|---|
| Assessment of respiratory paramenters (Maximal inspiratory pressure, maximal expiratory pressure, and voluntary peak cough flow))Also: Assessment of hand grip strength, Questionnaire: Index of pulmonary dysfunctionThe voluntary peak cough flow is measured using a pneumotachograph (BTL cardiopoint Spiro, BTL industries), which meets the recommendations of the American Thoracic Society and the European Respiratory Society for range and accuracy in forced expiratory maneuvers. Maximal expiratory and inspiratory pressures assessments were performed using a flanged rubber mouthpiece connected to a pressure manometer (Micro RPM, Vyaire Medical). Assessments are conducted according to the statements on respiratory muscle testing of the American Thoracic Society and the European Respiratory Society. Hand grip strength Grip strength is measured using DHD-1 digital hand dynamometer (SAEHAN®,Seahan Corporation), assessment follows recommendation of The American Society of Hand Therapists. | Other | Persons with HD |
Primary outcome
Maximal Hand grip strength
Time frame: Up to 35 weeks (once on a single screening visit)
Unit of Measure: kg Assessment followed recommendation of The American Society of Hand Therapists. HSG is measured using DHD-1 digital hand dynamometer (SAEHAN®,Seahan Corporation).
Voluntary peak cough flow
Time frame: Up to 35 weeks (once on a single screening visit)
Unit of measure: l/min Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Maximal expiratory pressure, Maximal inspiratory pressure
Time frame: Up to 35 weeks (once on a single screening visit)
Unite of measure: cmH2O Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
1 secondary outcome
Index of Pulmonary dysfunction
Time frame: Up to 35 weeks (once on a single screening visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Background: PubMed 27338194Jones U, Busse M, Enright S, Rosser AE. Respiratory decline is integral to disease progression in Huntington's disease. Eur Respir J. 2016 Aug;48(2):585-8. doi: 10.1183/13993003.02215-2015. Epub 2016 Jun 23.
- Background: PubMed 24886346Reyes A, Cruickshank T, Ziman M, Nosaka K. Pulmonary function in patients with Huntington's disease. BMC Pulm Med. 2014 May 26;14:89. doi: 10.1186/1471-2466-14-89.
- Background: PubMed 34077591Schumann-Werner B, Dogan I, Mirzazade S, Mall B, Overbeck R, Honrath P, Schulz JB, Reetz K, Werner CJ. Clinical predictors and neural correlates for compromised swallowing safety in Huntington disease. Eur J Neurol. 2021 Sep;28(9):2855-2862. doi: 10.1111/ene.14953. Epub 2021 Jun 24.
- Background: PubMed 38215057Jakusova J, Brozmanova M. Methods of Cough Assessment and Objectivization. Physiol Res. 2023 Dec 31;72(6):687-700. doi: 10.33549/physiolres.935062.
- Background: PubMed 30272099Ohara DG, Pegorari MS, Oliveira Dos Santos NL, de Fatima Ribeiro Silva C, Monteiro RL, Matos AP, Jamami M. Respiratory Muscle Strength as a Discriminator of Sarcopenia in Community-Dwelling Elderly: A Cross-Sectional Study. J Nutr Health Aging. 2018;22(8):952-958. doi: 10.1007/s12603-018-1079-4.
- Background: PubMed 27094394Efstathiou ID, Mavrou IP, Grigoriadis KE. Correlation Between Maximum Inspiratory Pressure and Hand-Grip Force in Healthy Young and Middle-Age Individuals. Respir Care. 2016 Jul;61(7):925-9. doi: 10.4187/respcare.04319. Epub 2016 Apr 19.
- Background: PubMed 28971054Shin HI, Kim DK, Seo KM, Kang SH, Lee SY, Son S. Relation Between Respiratory Muscle Strength and Skeletal Muscle Mass and Hand Grip Strength in the Healthy Elderly. Ann Rehabil Med. 2017 Aug;41(4):686-692. doi: 10.5535/arm.2017.41.4.686. Epub 2017 Aug 31.
- Background: PubMed 24993454Bahat G, Tufan A, Ozkaya H, Tufan F, Akpinar TS, Akin S, Bahat Z, Kaya Z, Kiyan E, Erten N, Karan MA. Relation between hand grip strength, respiratory muscle strength and spirometric measures in male nursing home residents. Aging Male. 2014 Sep;17(3):136-40. doi: 10.3109/13685538.2014.936001. Epub 2014 Jul 4.
- Background: PubMed 8306041Enright PL, Kronmal RA, Manolio TA, Schenker MB, Hyatt RE. Respiratory muscle strength in the elderly. Correlates and reference values. Cardiovascular Health Study Research Group. Am J Respir Crit Care Med. 1994 Feb;149(2 Pt 1):430-8. doi: 10.1164/ajrccm.149.2.8306041.
- Background: PubMed 37476315Srp M, Bartosova T, Klempir J, Lagnerova R, Gal O, Listvanova T, Jech R, Ruzicka E, Hoskovcova M. Expiratory Muscle Strength Training in Multiple System Atrophy: A Pilot Study. Mov Disord Clin Pract. 2023 May 19;10(7):1060-1065. doi: 10.1002/mdc3.13765. eCollection 2023 Jul.
- Background: PubMed 2587294Smeltzer SC, Lavietes MH, Troiano R, Cook SD. Testing of an Index of Pulmonary Dysfunction in Multiple Sclerosis. Nurs Res. 1989 Nov-Dec;38(6):370-4.
- Background: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Individual participant dataSharing planned: No
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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.
Romana Konvalinkova, MS principal investigator
General University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by General University Hospital, Prague at 1 site in Czechia.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 17 Mar 2025. 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximal Hand grip strength (time frame: Up to 35 weeks (once on a single screening visit)). The study lists 3 primary outcomes in all. 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 NCT06585332, which also lists 15 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 17 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.