Evidence map›Paper›PMID 34969405›Full record

Trial reportTrials2021

The effect of passive mobilization associated with blood flow restriction and combined with electrical stimulation on cardiorespiratory safety, neuromuscular adaptations, physical function, and quality of life in comatose patients in an ICU: a randomized controlled clinical trial.

Thaís Marina Pires de Campos Biazon, Cleiton Augusto Libardi, Jose Carlos Bonjorno Junior, Flávia Rossi Caruso, Tamara Rodrigues da Silva Destro, Naiara Garcia Molina, Audrey Borghi-Silva, Renata Gonçalves Mendes

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 41% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Thaís Marina Pires de Campos BiazonCardiopulmonary Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, Rod. Washington Luiz, km 235 - SP 310, CEP 13565-905, São Carlos, Brazil.
Cleiton Augusto LibardiLaboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, São Carlos, Brazil.
Jose Carlos Bonjorno JuniorDepartment of Medicine, Federal University of São Carlos, São Carlos, Brazil.
Flávia Rossi CarusoCardiopulmonary Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, Rod. Washington Luiz, km 235 - SP 310, CEP 13565-905, São Carlos, Brazil.
Tamara Rodrigues da Silva DestroCardiopulmonary Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, Rod. Washington Luiz, km 235 - SP 310, CEP 13565-905, São Carlos, Brazil.
Naiara Garcia MolinaCardiopulmonary Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, Rod. Washington Luiz, km 235 - SP 310, CEP 13565-905, São Carlos, Brazil.
Audrey Borghi-SilvaCardiopulmonary Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, Rod. Washington Luiz, km 235 - SP 310, CEP 13565-905, São Carlos, Brazil.
Renata Gonçalves MendesCardiopulmonary Physical Therapy Laboratory, Department of Physical Therapy, Federal University of São Carlos, Rod. Washington Luiz, km 235 - SP 310, CEP 13565-905, São Carlos, Brazil. renatamendes@ufscar.br.ORCID http://orcid.org/0000-0003-4683-2657
Universidade Federal de São Carlos · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntensive care unit-acquired atrophy and weakness are associated with high mortality, a reduction in physical function, and quality of life. Passive mobilization (PM) and neuromuscular electrical stimulation were applied in comatose patients; however, evidence is inconclusive regarding atrophy and weakness prevention. Blood flow restriction (BFR) associated with PM (BFRp) or with electrical stimulation (BFRpE) was able to reduce atrophy and increase muscle mass in spinal cord-injured patients, respectively. Bulky venous return occurs after releasing BFR, which can cause unknown repercussions on the cardiovascular system. Hence, the aim of this study was to investigate the effect of BFRp and BFRpE on cardiovascular safety and applicability, neuromuscular adaptations, physical function, and quality of life in comatose patients in intensive care units (ICUs).

methodsThirty-nine patients will be assessed at baseline (T0-18 h of coma) and randomly assigned to the PM (control group), BFRp, or BFRpE groups. The training protocol will be applied in both legs alternately, twice a day with a 4-h interval until coma awake, death, or ICU discharge. Cardiovascular safety and applicability will be evaluated at the first training session (T1). At T0 and 12 h after the last session (T2), muscle thickness and quality will be assessed. Global muscle strength and physical function will be assessed 12 h after T2 and ICU and hospital discharge for those who wake up from coma. Six and 12 months after hospital discharge, physical function and quality of life will be re-assessed. DISCUSSION: In view of applicability, the data will be used to inform the design and sample size of a prospective trial to clarify the effect of BFRpE on preventing muscle atrophy and weakness and to exert the greatest beneficial effects on physical function and quality of life compared to BFRp in comatose patients in the ICU.

trial registrationUniversal Trial Number (UTN) Registry UTN U1111-1241-4344. Retrospectively registered on 2 October 2019. Brazilian Clinical Trials Registry (ReBec) RBR-2qpyxf . Retrospectively registered on 21 January 2020, http://ensaiosclinicos.gov.br/rg/RBR-2qpyxf/.

Indexed as

ComaQuality of LifeElectric StimulationHumansIntensive Care UnitsProspective StudiesBlood flow restrictionCardiorespiratory safetyCritical careElectrical stimulationIntensive care unit-acquired atrophyIntensive care unit-acquired weaknessNeuromuscular adaptationsPhysical functionQuality of life

Identifiers

PMID34969405
PMCPMC8719392
OpenAlexW4200020724

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.