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

Intensive Care Unit Clinical Trial

— HHD-ICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296381
• Other study ID #: 6.131.540
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: December 30, 2027

Study information

• Verified date: March 2024
• Source: University of Pernambuco
• Contact: Shirley Campos
• Phone: 5581999413087
• Email: shirley.campos[@]ufpe.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 30, 2027
• Est. primary completion date: October 31, 2024
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Unit
• Muscle Strength

Locations

Country	Name	City	State
Brazil	Federal University of Pernambuco (UFPE)	Recife	PE
Brazil	Hospital Nossa Senhora das Graças	Recife	PE
Brazil	Hospital Otávio de Freitas	Recife	PE

Sponsors (3)

Lead Sponsor	Collaborator
University of Pernambuco	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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