Normative Values for Peripheral Muscle Strenght 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). Additionally, the level of physical activity (International Physical Activity Questionnaire - Short Form) will also be assessed in the . 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 (Perme ICU Mobility Score).

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: Shirley Campos; Phone Number: 5581999413087; Email: shirley.campos@ufpe.br
• Study Contact Backup: Name: Pedro Vinicius Porfirio; Phone Number: 5581993954400; Email: pedro.porfirio@ufpe.br

Study Locations

• Brazil
  • PE
    • Recife, PE, 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, PE, Brazil, 50920-460
      • Not yet recruiting
      • Hospital Otávio de Freitas
      • Contact: Shirley L Campos; Phone Number: +5581999413087; Email: shirley.campos@ufpe.br
    • Recife, PE, Brazil, 51030-020
      • Recruiting
      • Hospital Nossa Senhora Das Gracas
      • Contact: Shirley L Campos; Phone Number: +5581999413087; Email: shirley.campos@ufpe.br
      • Contact: Lidier Roberta Moraes Nogueira; Phone Number: +5581995479644; Email: lidierroberta@outlook.com
      • Sub-Investigator: Jose Douglas de Souza Cordeiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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 hand held dynamometer	Strength of the muscles of the upper and lower limbs using a digital hand held dinamometer in healthy individuals and critical patients.	Day 1
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

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
Mobility in ICU measured by Perme Intensive Care Unit Mobility Score	The Perme Intensive Care Unit Mobility Score comprises 15 items grouped into 7 categories: (1) mental state, (2) potential barriers to mobility, (3) strength, (4) in bed mobility, (5) transfers, (6) gait and (7) endurance. The minimum score is 0 and the maximum is 32, where the higher the score, the better outcome.	Day 1
Level of frailty in 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 physical activity in young adults by the International Physical Activity Questionnaire - Short Form	The International Physical Activity Questionnaire - Short Form (IPAQ-SF) has 8 items that record the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting.	Day 1

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 30, 2027

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 (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Critically ill; Peripheral muscle
• 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