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

NCT ID: NCT06296381

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2028-12-30

Brief Summary

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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

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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).

Conditions

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Intensive Care Unit Muscle Strength

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Shirley Lima Campos

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pedro Vinicius Porfirio

Role: PRINCIPAL_INVESTIGATOR

University of Pernambuco

Shirley Campos

Role: STUDY_CHAIR

University of Pernambuco

Locations

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Complexo Hospitalar Unimed Recife - CHUR

Recife, Brazil, Brazil

Site Status RECRUITING

Federal University of Pernambuco (UFPE)

Recife, Pernambuco, Brazil

Site Status RECRUITING

Hospital Otávio de Freitas

Recife, Pernambuco, Brazil

Site Status RECRUITING

Hospital Nossa Senhora das Graças

Recife, Pernambuco, Brazil

Site Status ACTIVE_NOT_RECRUITING

Countries

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Brazil

Central Contacts

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Shirley Campos

Role: CONTACT

+55 81 9941-3087

Pedro Vinicius Porfirio

Role: CONTACT

5581993954400

Facility Contacts

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Shirley L Campos, Professor

Role: primary

+55 81 9941-3087

Pedro Vinicius Porfirio

Role: backup

+5581993954400

Shirley Campos

Role: primary

+5581999413087

Pedro Vinicius Porfirio

Role: backup

+5581993954400

Shirley L Campos

Role: primary

+5581999413087

References

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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.

Reference Type BACKGROUND
PMID: 12045055 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10155148 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32228469 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26955213 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21570036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36215867 (View on PubMed)

Other Identifiers

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6.131.540

Identifier Type: -

Identifier Source: org_study_id

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