Intensive Care UnitHHD-ICUNCT06296381
Normative Values for Peripheral Muscle Strength in Critical Patients and Healthy Individuals
An observational study of Intensive Care Unit and Muscle Strength, run by University of Pernambuco at 4 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intensive Care Unit, Muscle Strength
- How many people
- 180 participants
- Where
- 4 sitesBrazil
- Study dates
- 1 Mar 2024to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil4 sites, 3 recruiting
- Recruiting
Complexo Hospitalar Unimed Recife - CHUR
Recife, Brazil, 50070470
Shirley L Campos, Professor, +55 81 9941-3087, shirley.campos@ufpe.br
Pedro Vinicius Porfirio, +5581993954400, pedro.porfirio@ufpe.br
- Recruiting
Federal University of Pernambuco (UFPE)
Recife, Pernambuco, 50740-600
Shirley Campos, +5581999413087, shirley.campos@ufpe.br
Pedro Vinicius Porfirio, +5581993954400, pedro.porfirio@ufpe.br
- Recruiting
Hospital Otávio de Freitas
Recife, Pernambuco, 50920-460
Shirley L Campos, +5581999413087, shirley.campos@ufpe.br
- Active, not recruiting
Hospital Nossa Senhora das Graças
Recife, Pernambuco, 51030-020
About this study
Official title: Analysis of Peripheral Muscle Strength Measurement Methods in Healthy Individuals and Critical Patients: A Health Technology Assessment
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.
Read the detailed 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). 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
- Intensive Care Unit, Muscle Strength
- Keywords
- Healthy Volunteers, Critically ill, Peripheral muscle
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Day 1
Secondary outcomes (5)
Peripheral muscle strength measured by hand grip dynamometer
Peripheral muscle strength assessed bilaterally through digital handgrip dynamometry in healthy individuals and critical patients.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Adverse Events
An adverse event is defined as any unfavorable or unintended medical sign, symptom, or condition that arises during or after the peripheral muscle strength assessment.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Mar 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Pernambuco, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Shirley Lima Campos, University of Pernambuco
- Investigators
- Pedro Vinicius Porfirio, Principal investigator, University of PernambucoShirley Campos, Study chair, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296381
- Sponsor's protocol ID
- 6.131.540
- Acronym
- HHD-ICU
- Status last verified
- Sep 2025
- First submitted
- 28 Feb 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ganesh KM, Krishna B. Utility of Clinical Frailty Scale in Intensive Care Unit. Indian J Crit Care Med. 2025 Apr;29(4):289-290. doi: 10.5005/jp-journals-10071-24959.
PubMed 40322240Bruno RR, Wernly B, Bagshaw SM, van den Boogaard M, Darvall JN, De Geer L, de Gopegui Miguelena PR, Heyland DK, Hewitt D, Hope AA, Langlais E, Le Maguet P, Montgomery CL, Papageorgiou D, Seguin P, Geense WW, Silva-Obregon JA, Wolff G, Polzin A, Dannenberg L, Kelm M, Flaatten H, Beil M, Franz M, Sviri S, Leaver S, Guidet B, Boumendil A, Jung C. The Clinical Frailty Scale for mortality prediction of old acutely admitted intensive care patients: a meta-analysis of individual patient-level data. Ann Intensive Care. 2023 May 3;13(1):37. doi: 10.1186/s13613-023-01132-x.
PubMed 37133796Saraiva 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.
PubMed 32228469Samosawala 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.
PubMed 26955213Stark 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.
PubMed 21570036Nunez-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.
PubMed 36215867
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Peripheral Muscle Strength Measurement Methods in Healthy Individuals and Critical Patients: A Health Technology Assessment
- ClinicalTrials.gov ID
- NCT06296381
- Acronym / sponsor ID
- HHD-ICU / 6.131.540
- Conditions
- Intensive Care Unit, Muscle Strength
- Keywords
- Healthy Volunteers, Critically ill, Peripheral muscle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Collaborators
- Universidade Federal de Pernambuco, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peripheral muscle strength measured by hand held dynamometer
Time frame: Day 1
Strength of the muscles of the upper and lower limbs using a digital hand held dynamometer in healthy individuals and critical patients.
Peripheral muscle strength measured by Medical Research Council score
Time frame: 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).
5 secondary outcomes
Peripheral muscle strength measured by hand grip dynamometer
Time frame: Day 1
Level of activity in ICU at the moment
Time frame: Day 1
Level of frailty in healthy older adults by the Multidimensional Assessment of Older People (AMPI-AB)
Time frame: Day 1
Level of frailty in ICU older adults by the Clinical Frailty Scale (CFS)
Time frame: Day 1
Adverse Events
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Background: PubMed 40322240Ganesh KM, Krishna B. Utility of Clinical Frailty Scale in Intensive Care Unit. Indian J Crit Care Med. 2025 Apr;29(4):289-290. doi: 10.5005/jp-journals-10071-24959.
- Background: PubMed 37133796Bruno RR, Wernly B, Bagshaw SM, van den Boogaard M, Darvall JN, De Geer L, de Gopegui Miguelena PR, Heyland DK, Hewitt D, Hope AA, Langlais E, Le Maguet P, Montgomery CL, Papageorgiou D, Seguin P, Geense WW, Silva-Obregon JA, Wolff G, Polzin A, Dannenberg L, Kelm M, Flaatten H, Beil M, Franz M, Sviri S, Leaver S, Guidet B, Boumendil A, Jung C. The Clinical Frailty Scale for mortality prediction of old acutely admitted intensive care patients: a meta-analysis of individual patient-level data. Ann Intensive Care. 2023 May 3;13(1):37. doi: 10.1186/s13613-023-01132-x.
- Background: PubMed 32228469Saraiva 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.
- Background: PubMed 26955213Samosawala 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.
- Background: PubMed 21570036Stark 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.
- Background: PubMed 36215867Nunez-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pedro Vinicius Porfirio principal investigator
University of Pernambuco
Shirley Campos study chair
University of Pernambuco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit and Muscle Strength, run by University of Pernambuco at 4 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shirley Campos (+55 81 9941-3087, shirley.campos@ufpe.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral muscle strength measured by hand held dynamometer (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06296381, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.