Clinical trial NCT06296381: Normative Values for Peripheral Muscle Strength in Critical Patients and Healthy Individuals
Official title: Analysis of Peripheral Muscle Strength Measurement Methods in Healthy Individuals and Critical Patients: A Health Technology Assessment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intensive Care Unit
Muscle Strength
Keywords: Healthy Volunteers
Critically ill
Peripheral muscle
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
Collaborators: name: Universidade Federal de Pernambuco
name: Cnpq Conselho Nacional de Desenvolvimento Científico e Tecnológico National Counsel of Technological and Scientific Development
First posted: 2024-03-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Peripheral muscle strength measured by hand held dynamometer
timeFrame: Day 1
measure: Peripheral muscle strength measured by Medical Research Council score
timeFrame: Day 1
Secondary outcomes:
measure: Peripheral muscle strength measured by hand grip dynamometer
timeFrame: Day 1
measure: Level of activity in ICU at the moment
timeFrame: Day 1
measure: Level of frailty in older adults by the Multidimensional Assessment of Older People (AMPI-AB)
timeFrame: Day 1
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Federal University of Pernambuco (UFPE)
state: PE
city: Recife
country: Brazil
facility: Hospital Otávio de Freitas
state: PE
city: Recife
country: Brazil
facility: Hospital Nossa Senhora das Graças
state: PE
city: Recife
country: Brazil
facility: Complexo Hospitalar Unimed Recife - CHUR
Study officials:
affiliation: University of Pernambuco
name: Pedro Vinicius Porfirio
role: STUDY_DIRECTOR
affiliation: University of Pernambuco
name: Shirley Campos
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Perme C, Nawa RK, Winkelman C, Masud F. A tool to assess mobility status in critically ill patients: the Perme Intensive Care Unit Mobility Score. Methodist Debakey Cardiovasc J. 2014 Jan-Mar;10(1):41-9. doi: 10.14797/mdcj-10-1-41.
citation: 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.
citation: 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.
citation: 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.
citation: Hermans G, Clerckx B, Vanhullebusch T, Segers J, Vanpee G, Robbeets C, Casaer MP, Wouters P, Gosselink R, Van Den Berghe G. Interobserver agreement of Medical Research Council sum-score and handgrip strength in the intensive care unit. Muscle Nerve. 2012 Jan;45(1):18-25. doi: 10.1002/mus.22219.