Normative Values for Peripheral Muscle Strength in Critical Patients and Healthy Individuals (HHD-ICU)

University of Pernambuco

Status: Enrolling

Conditions: Muscle Strength; Intensive Care Unit

Study type: Observational

Funder types: Other

Identifiers

NCT06296381

6.131.540

Details and patient eligibility

About

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.

Full 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 wounds/dressings, 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). 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 patient's mobility status (ICU Mobility Scale).

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 participant's medical records, including anthropometric data, sociodemographic information, neurological and cardiovascular assessments, current medications, and laboratory test results. The participant's 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).

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy individuals of both sexes
• Patients and volunteers aged between 18 and 90 years old (youth/adults/elderly).
• Patients admitted to the ICU.
• No recent muscle injuries of both limbs for a past 6-months.

Exclusion criteria

Patients and volunteers < 20 years and > 90 years

Healthy individuals

• Unable to follow command completely
• Severe osteoporosis or neuromuscular disease leading to decreased muscle strength
• Presence of opened or infectious wound
• Presence of pain in evaluating muscle groups

Patients in ICU

• Unable to follow command completely
• Acute stroke
• Hip fracture, unstable cervical spine or pathological fracture
• Recent surgery involving the upper airways, chest, abdomen, or limbs
• Presence of opened or infectious wound
• Presence of pain in evaluating muscle groups

Trial design

180 participants in 2 patient groups

Patients in the ICU

Description:

The ICU sample will comprised patients of both sexes, aged between 18 and 90 years old, able to do volitional tests and without barriers to the assessment of peripheral muscle strength.

Healthy Participants

Description:

The healthy sample will comprised volunteers of both sexes, aged between 18 and 90 years old, able to do volitional tests and without barriers to the assessment of peripheral muscle strength.