Analysis of Peripheral Muscle Strength Measurement Methods in Healthy Individuals and Critical Patients: A Health Technology Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Peripheral muscle strength measured by Medical Research Council score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Peripheral muscle strength measured by Medical Research Council score
时间窗: Day 1
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).
Peripheral muscle strength measured by hand held dynamometer
时间窗: Day 1
Strength of the muscles of the upper and lower limbs using a digital hand held dynamometer in healthy individuals and critical patients.
次要结局
- 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)
研究者
Shirley Lima Campos
Associate Professor
University of Pernambuco