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

Официальное название

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

Обзор

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.

Подробное описание

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).

Первичные конечные точки

• Peripheral muscle strength measured by hand held dynamometer [Срок оценки: Day 1]
• Peripheral muscle strength measured by Medical Research Council score [Срок оценки: Day 1]

Вторичные конечные точки (5)

• Peripheral muscle strength measured by hand grip dynamometer [Срок оценки: Day 1]
• Level of activity in ICU at the moment [Срок оценки: Day 1]
• Level of frailty in healthy older adults by the Multidimensional Assessment of Older People (AMPI-AB) [Срок оценки: Day 1]
• Level of frailty in ICU older adults by the Clinical Frailty Scale (CFS) [Срок оценки: Day 1]
• Adverse Events [Срок оценки: Day 1]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бразилия · 4 центра

• Complexo Hospitalar Unimed Recife - CHUR — Recife
• Federal University of Pernambuco (UFPE) — Recife
• Hospital Otávio de Freitas — Recife
• Hospital Nossa Senhora das Graças — Recife

Публикации

• Ganesh KM, Krishna B. Utility of Clinical Frailty Scale in Intensive Care Unit. Indian J Crit Care Med. 2025 Apr;29(4):289-290. doi: 10.5005/jp-journals-10071-24959. PMID 40322240
• Bruno RR, Wernly B, Bagshaw SM, van den Boogaard M, Darvall JN, De Geer L, de Gopegui Miguelena PR, Heyland DK, Hewitt D, Hope AA, Langlais E, Le Maguet P, Montgomery CL, Papageorgiou D, Seguin P, Geense WW, Silva-Obregon JA, Wolff G, Polzin A, Dannenberg L, Kelm M, Flaatten H, Beil M, Franz M, Sviri S, Leaver S, Guidet B, Boumendil A, Jung C. The Clinical Frailty Scale for mortality prediction of PMID 37133796
• 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. PMID 32228469
• 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. PMID 26955213
• 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. PMID 21570036
• 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. PMID 36215867

Идентификаторы

NCT: NCT06296381 · 6.131.540

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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