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

NCT06296381 | Recruiting DMC

• 1 other identifier: 6.131.540
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 4

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.

Conditions

Intensive Care Unit; Muscle Strength

Keywords

Healthy Volunteers; Critically ill; Peripheral muscle

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Peripheral muscle strength measured by hand grip dynamometer

  Day 1

• Level of activity in ICU at the moment

  Day 1

• Level of frailty in healthy older adults by the Multidimensional Assessment of Older People (AMPI-AB)

  Day 1

• Level of frailty in ICU older adults by the Clinical Frailty Scale (CFS)

  Day 1

• Adverse Events

  Day 1

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pernambuco: lead
• Universidade Federal de Pernambuco: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (4)

Complexo Hospitalar Unimed Recife - CHUR

Recife, Brazil, 50070470, Brazil

RECRUITING

Federal University of Pernambuco (UFPE)

Recife, Pernambuco, 50740-600, Brazil

RECRUITING

Hospital Otávio de Freitas

Recife, Pernambuco, 50920-460, Brazil

RECRUITING

Hospital Nossa Senhora das Graças

Recife, Pernambuco, 51030-020, Brazil

ACTIVE NOT RECRUITING

Related Publications (6)

• 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.

  PMID: 12045055 BACKGROUND

• 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.

  PMID: 10155148 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pedro Vinicius Porfirio

  University of Pernambuco

  PRINCIPAL INVESTIGATOR

• Shirley Campos

  University of Pernambuco

  STUDY CHAIR

Central Study Contacts

Shirley Campos

CONTACT

+55 81 9941-3087; shirley.campos@ufpe.br

Pedro Vinicius Porfirio

CONTACT

5581993954400; pedro.porfirio@ufpe.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

BR (4)