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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care Unit; Muscle Strength

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 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).

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Pedro Vinicius Porfirio; Phone Number: 5581993954400; Email: pedro.porfirio@ufpe.br
• Study Contact Backup: Name: Shirley Campos; Phone Number: +55 81 9941-3087; Email: shirley.campos@ufpe.br

Study Locations

• Brazil
  • Brazil
    • Recife, Brazil, Brazil, 50070470
      • Recruiting
      • Complexo Hospitalar Unimed Recife - CHUR
      • Contact: Pedro Vinicius Porfirio; Phone Number: +5581993954400; Email: pedro.porfirio@ufpe.br
      • Contact: Shirley L Campos, Professor; Phone Number: +55 81 9941-3087; Email: shirley.campos@ufpe.br
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50740-600
      • Recruiting
      • Federal University of Pernambuco (UFPE)
      • Contact: Shirley Campos; Phone Number: +5581999413087; Email: shirley.campos@ufpe.br
      • Contact: Pedro Vinicius Porfirio; Phone Number: +5581993954400; Email: pedro.porfirio@ufpe.br
      • Sub-Investigator: Lucas Rafael da Silva Fraga
    • Recife, Pernambuco, Brazil, 50920-460
      • Recruiting
      • Hospital Otávio de Freitas
      • Contact: Shirley L Campos; Phone Number: +5581999413087; Email: shirley.campos@ufpe.br
    • Recife, Pernambuco, Brazil, 51030-020
      • Active, not recruiting
      • Hospital Nossa Senhora das Graças

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population comprised adult and elderly individuals of both sexes able to do volitional tests. For the healthy sample, volunteers without barriers to the assessment of peripheral muscle strength will meet the inclusion criteria while, for the critical patient population, the sample will include individuals hospitalized in the Intensive Care Unit (ICU) who also do not have barriers to the assessment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients in the ICU; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral muscle strength measured by Medical Research Council score	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).	Day 1
Peripheral muscle strength measured by hand held dynamometer	Strength of the muscles of the upper and lower limbs using a digital hand held dynamometer in healthy individuals and critical patients.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral muscle strength measured by hand grip dynamometer	Peripheral muscle strength assessed bilaterally through digital handgrip dynamometry in healthy individuals and critical patients.	Day 1
Level of activity in ICU at the moment	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.	Day 1
Adverse Events	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.	Day 1
Level of frailty in healthy older adults by the Multidimensional Assessment of Older People (AMPI-AB)	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.	Day 1
Level of frailty in ICU older adults by the Clinical Frailty Scale (CFS)	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.	Day 1

Collaborators and Investigators

• Sponsor: University of Pernambuco
• Collaborators: Universidade Federal de Pernambuco; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Pedro Vinicius Porfirio, University of Pernambuco; Study Chair: Shirley Campos, University of Pernambuco

Publications and helpful links

General Publications

• Stark T, Walker B, Phillips JK, Fejer R, Beck R. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011 May;3(5):472-9. doi: 10.1016/j.pmrj.2010.10.025.
• Saraiva MD, Venys AL, Abdalla FLP, Fernandes MS, Pisoli PH, Sousa DMDRV, Bianconi BL, Henrique EA, Garcia VSS, Maia LHM, Suzuki GS, Serrano PG, Hiratsuka M, Szlejf C, Jacob-Filho W, Paschoal SMP. AMPI-AB validity and reliability: a multidimensional tool in resource-limited primary care settings. BMC Geriatr. 2020 Mar 30;20(1):124. doi: 10.1186/s12877-020-01508-9.
• Samosawala NR, Vaishali K, Kalyana BC. Measurement of muscle strength with handheld dynamometer in Intensive Care Unit. Indian J Crit Care Med. 2016 Jan;20(1):21-6. doi: 10.4103/0972-5229.173683.
• Nunez-Cortes R, Cruz BDP, Gallardo-Gomez D, Calatayud J, Cruz-Montecinos C, Lopez-Gil JF, Lopez-Bueno R. Handgrip strength measurement protocols for all-cause and cause-specific mortality outcomes in more than 3 million participants: A systematic review and meta-regression analysis. Clin Nutr. 2022 Nov;41(11):2473-2489. doi: 10.1016/j.clnu.2022.09.006. Epub 2022 Sep 16.
• Lumbroso L, Doz F, Urbieta M, Levy C, Bours D, Asselain B, Vedrenne J, Zucker JM, Desjardins L. Chemothermotherapy in the management of retinoblastoma. Ophthalmology. 2002 Jun;109(6):1130-6. doi: 10.1016/s0161-6420(02)01053-9.
• Teale JD. The diagnostic application of serum growth hormone, insulin-like growth factor (IGF), and IGF binding protein measurements. J Int Fed Clin Chem. 1995 Nov;6(5):164-8.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 13, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Critically ill; Peripheral muscle
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness
• Other Study ID Numbers: 6.131.540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No