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OpenTrials
Completed

NCT Number: NCT06585332

Handgrip and Respiratory Dysfunction in HD Patients.

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Genetic confirmed diagnosis of Huntington's disease

Exclusion criteria

  • 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

Treatment and study plan

Assessment of respiratory paramenters (Maximal inspiratory pressure, maximal expiratory pressure, and voluntary peak cough flow))

Other

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.

Other names: Assessment of hand grip strength, Questionnaire: Index of pulmonary dysfunction

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. Index of Pulmonary dysfunction

    Time frame: Up to 35 weeks (once on a single screening visit)

    Questionnaire of four questions. Scale range: 0-11 points A higher score indicates a worse pulmonary condition.

Sponsors and collaborators

Lead sponsor

General University Hospital, Prague

Other

Registry information

Official study title

Hand Grip Strength As a Screening Tool for Respiratory Dysfunction in Huntington's Disease

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2024
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.