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NCT Number: NCT06296381

Normative Values for Peripheral Muscle Strength in Critical Patients and Healthy Individuals

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.

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Key information

Conditions

Intensive Care Unit Critical Illness Disease Attributes Muscle Strength Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Complexo Hospitalar Unimed Recife - CHUR, Recife, Brazil

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About this study

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).

Who can participate

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

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

Treatment and study plan

Primary outcomes

  1. Peripheral muscle strength measured by hand held dynamometer

    Time frame: Day 1

    Strength of the muscles of the upper and lower limbs using a digital hand held dynamometer in healthy individuals and critical patients.

  2. Peripheral muscle strength measured by Medical Research Council score

    Time frame: Day 1

    Global muscle strength using the Medical Research Council-sum score (MRC score) in healthy individuals and critical patients. The MRC score is obtained by evaluating muscle groups in the upper and lower extremities (wrist extensors, elbow flexors, abductors of the shoulder, dorsal ankle flexors, knee extensors, and hip flexors). For each muscle group will be assigned a score between 0 and 5, and the total score can vary between 0 (worse outcome) up to 60 points (the better outcome).

Secondary outcomes

  1. Peripheral muscle strength measured by hand grip dynamometer

    Time frame: Day 1

    Peripheral muscle strength assessed bilaterally through digital handgrip dynamometry in healthy individuals and critical patients.

  2. Level of activity in ICU at the moment

    Time frame: Day 1

    The ICU Mobility Scale is a tool used to assess mobility milestones in critically ill patients, categorizing them on a scale from 0 to 10 as follows: (0) no mobility (lying in bed), (1) sitting in bed (performing exercises), (2) passively moved to a chair (without standing), (3) sitting at the edge of the bed, (4) standing, (5) transferring from bed to chair, (6) marching in place (at the bedside), (7) walking with assistance from two or more people, (8) walking with assistance from one person, (9) walking independently with a gait aid, and (10) walking independently without a gait aid. The scale ranges from a minimum of 0 to a maximum of 10, with higher scores indicating better functional outcomes.

  3. Level of frailty in healthy older adults by the Multidimensional Assessment of Older People (AMPI-AB)

    Time frame: Day 1

    The AMPI-AB is composed of 17 questions based on well-known and validated scores used to detect relevant geriatric problems, such as lack of social support, multimorbidity, polypharmacy, cognitive and sensory impairment, physical limitations, depression, falls, functional dependence, weight loss and poor oral health. The total score can vary between 0 (the best outcome) up to 21 (the worst outcome) and classifies older adults in low, intermediate or high complexity of care.

  4. Level of frailty in ICU older adults by the Clinical Frailty Scale (CFS)

    Time frame: Day 1

    The Clinical Frailty Scale (CFS) is a well-validated tool developed to quantify the degree of frailty and disability in older adults. It is based on clinical judgment and provides a global measure of vulnerability to adverse health outcomes. The scale ranges from 1 (very fit, the best outcome) to 9 (terminally ill, the worst outcome), with each incremental score reflecting a greater degree of frailty, functional dependence, and health decline. The CFS is supported by a visual chart that guides clinicians in the classification of frailty levels.

  5. Adverse Events

    Time frame: Day 1

    An adverse event is defined as any unfavorable or unintended medical sign, symptom, or condition that arises during or after the peripheral muscle strength assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Pedro Vinicius Porfirio

CONTACT

[email protected]

5581993954400

Shirley Campos

CONTACT

[email protected]

+55 81 9941-3087

Sponsors and collaborators

Lead sponsor

University of Pernambuco

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Universidade Federal de Pernambuco

Registry information

Official study title

Analysis of Peripheral Muscle Strength Measurement Methods in Healthy Individuals and Critical Patients: A Health Technology Assessment

Acronym: HHD-ICU

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Mar 6, 2024
Registry last updated
Sep 18, 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.

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