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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorUniversity of Pernambuco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

180 Participants
are grouped into 2 trial groups
Group A: Patients in the ICU
Group B: Healthy Participants

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1
2

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).

Time frame
Day 1

Secondary outcomes

1

Peripheral muscle strength measured by hand grip dynamometer

Peripheral muscle strength assessed bilaterally through digital handgrip dynamometry in healthy individuals and critical patients.

Time frame
Day 1
2

Level of activity in ICU at the moment

The ICU Mobility Scale is a tool used to assess mobility milestones in critically ill patients, categorizing them on a scale from 0 to 10 as follows: (0) no mobility (lying in bed), (1) sitting in bed (performing exercises), (2) passively moved to a chair (without standing), (3) sitting at the edge of the bed, (4) standing, (5) transferring from bed to chair, (6) marching in place (at the bedside), (7) walking with assistance from two or more people, (8) walking with assistance from one person, (9) walking independently with a gait aid, and (10) walking independently without a gait aid. The scale ranges from a minimum of 0 to a maximum of 10, with higher scores indicating better functional outcomes.

Time frame
Day 1
3

Level of frailty in healthy 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.

Time frame
Day 1
4

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

The Clinical Frailty Scale (CFS) is a well-validated tool developed to quantify the degree of frailty and disability in older adults. It is based on clinical judgment and provides a global measure of vulnerability to adverse health outcomes. The scale ranges from 1 (very fit, the best outcome) to 9 (terminally ill, the worst outcome), with each incremental score reflecting a greater degree of frailty, functional dependence, and health decline. The CFS is supported by a visual chart that guides clinicians in the classification of frailty levels.

Time frame
Day 1

Other outcomes

Sponsors and contacts

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University of Pernambuco

Lead sponsor

Universidade Federal de Pernambuco

Collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Collaborator