Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296381
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-28
Brief Title:
Normative Values for Peripheral Muscle Strength in Critical Patients and Healthy Individuals
Sponsor:
University of Pernambuco
Organization:
University of Pernambuco
Study Overview
Official Title:
Analysis of Peripheral Muscle Strength Measurement Methods in Healthy Individuals and Critical Patients A Health Technology Assessment
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HHD-ICU
Brief Summary:
Muscle strength is an important indicator of overall health and is a factor that has been associated with increased mortality in critical patients Its measurement must be reliable and reproducible to ensure a quality outcome for clinical applicability Recently the use of digital handheld dynamometers in intensive care has gained support however analysis becomes challenging due to the absence of standardized reference equations for the Brazilian population The aim of this study is to develop reference equations for the Brazilian population and define specific cutoff points for men women healthy individuals and critical patients
Detailed Description:
For this 3-year observational study the population will consist of adult and elderly individuals of both sexes for the healthy sample patients without barriers to the assessment of peripheral muscle strength will meet the inclusion criteria specifically areas with woundsdressings burns segments with fractures or immobilization devices while for the critical patient population the sample will comprise patients who are hospitalized in the Intensive Care Unit ICU
In the case of assessing healthy participants an evaluation of the musculoskeletal system will be conducted to measure muscle strength handgrip dynamometry and peripheral hand held muscle dynamometry Additionally the level of physical activity International Physical Activity Questionnaire - Short Form will also be assessed in the Regarding critical patients if the participant meets the criteria the evaluation protocol will be carried out which includes peripheral muscle strength assessment Medical Research Council scale Hand Dynamometer and the Hand-Held Dynamometer and the patients mobility status Perme ICU Mobility Score
Daily screening will take place in the ICU with eligibility assessed during the screening process If eligible secondary data related to the critical condition will be extracted from the participants medical records including anthropometric data sociodemographic information neurological and cardiovascular assessments current medications and laboratory test results The participants hemodynamic and respiratory stability will be monitored using a multiparameter monitor recording data such as blood pressure heart rate peripheral saturation and respiratory rate A cardiorespiratory and clinical safety checklist will also be completed prior to conducting tests for all patients regardless of whether they are using mechanical ventilation The instruments used for assessment the muscle strength are the Digital Hand Dynamometer Saehan Corporation DHD-1 and the Hand Held Dynamometer HOGGAN SCIENTIFIC LLC microFET2
In the case of assessing healthy participants an evaluation of the musculoskeletal system will be conducted to measure muscle strength handgrip dynamometry and peripheral hand held muscle dynamometry Additionally the level of physical activity International Physical Activity Questionnaire - Short Form will also be assessed in the Regarding critical patients if the participant meets the criteria the evaluation protocol will be carried out which includes peripheral muscle strength assessment Medical Research Council scale Hand Dynamometer and the Hand-Held Dynamometer and the patients mobility status Perme ICU Mobility Score
Daily screening will take place in the ICU with eligibility assessed during the screening process If eligible secondary data related to the critical condition will be extracted from the participants medical records including anthropometric data sociodemographic information neurological and cardiovascular assessments current medications and laboratory test results The participants hemodynamic and respiratory stability will be monitored using a multiparameter monitor recording data such as blood pressure heart rate peripheral saturation and respiratory rate A cardiorespiratory and clinical safety checklist will also be completed prior to conducting tests for all patients regardless of whether they are using mechanical ventilation The instruments used for assessment the muscle strength are the Digital Hand Dynamometer Saehan Corporation DHD-1 and the Hand Held Dynamometer HOGGAN SCIENTIFIC LLC microFET2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None