Evidence map›Paper›PMID 32430078›Full record

ArticleTrials2020

Supervised exercise protocol for lower limbs in subjects with chronic venous disease: an evaluator-blinded, randomized clinical trial.

Esther Fernandes Tinoco Volpe, Vanessa R Resqueti, Ana Aline Marcelino da Silva, Lucien Peroni Gualdi, Guilherme A F Fregonezi

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.6field-weighted citation impact, top 16% 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

6 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
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

5 authors at 2 institutions in 1 country.

Esther Fernandes Tinoco VolpePneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil.
Vanessa R ResquetiPneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil.
Ana Aline Marcelino da SilvaPneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil.
Lucien Peroni GualdiPneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil.
Guilherme A F FregoneziPneumoCardioVascular Lab/HUOL Hospital Universitário Onofre Lopes, Empresa Brasileira de Serviços Hospitalares (EBSERRH) Departamento de Fisioterapia Universidade Federal do Rio Grande do Norte, Campus Universitário Central, Caixa Postal 1524/ Campus Universitário Lagoa Nova, Natal, Rio Grande do Norte, CEP: 59078-900, Brazil. fregonezi.guilherme@gmail.com.
Universidade Federal do Rio Grande do Norte · BRHospital Universitário Onofre Lopes · BR

Funding

Conselho Nacional de Desenvolvimento Científico e Tecnológico 312876/2018-1Conselho Nacional de Desenvolvimento Científico e Tecnológico 315580/2018-6
6 · The paper itself

Abstract

backgroundChronic venous insufficiency (CVI) causes pathophysiological changes in the lower-limb muscles, particularly the calf muscles, and limits ankle range of motion (ROM). These changes reduce functional activities and decrease quality of life (QOL). Although several studies have shown the benefits of exercise (strengthening the calf muscles to improve calf-muscle pumping and QOL) in patients with CVI, few studies are randomized controlled trials. This has led to a weak indication of exercise for the treatment of patients with CVI. The aim of this study is to analyze the effects of a supervised exercise program to improve calf-muscle endurance as well as QOL in patients with CVI. METHODS/

designThis is an evaluator-blind, randomized clinical trial with an 8-week duration and a follow-up evaluation at week 16. A pilot study with subjects with a CVI diagnosis will be performed to calculate sample size. The participants will be randomly allocated (1:1) into a treatment or a control group (usual care/no intervention). The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening and cardiovascular exercises. The participants from both groups will participate in a health education lecture. Primary outcomes are changes in calf-muscle endurance and QOL score. Secondary outcomes are changes in exercise capacity, ankle ROM, electrical muscle activity and cardiac output. The first statistical comparison will be performed after 8 weeks' intervention. DISCUSSION: Patients with CVI may have an impaired calf-muscle pump and decreased exercise capacity. A randomized controlled trial evaluating a supervised exercise program should provide much needed information on the management of CVI to promote health and independence.

trial registrationThis study was registered on the Brazilian Clinical Trials Database (REBEC) (RBR-57xtk7). The results will be disseminated at scientific events, presentations, and publications in peer-reviewed journals.

Indexed as

Exercise TherapyAnkle JointBrazilChronic DiseaseHumansLegMuscle, SkeletalPilot ProjectsPlethysmographyQuality of LifeRandomized Controlled Trials as TopicRange of Motion, ArticularTreatment OutcomeVenous InsufficiencyExerciseExercise therapyRandomized controlled trialRehabilitationResistance trainingVenous insufficiency

Identifiers

PMID32430078
PMCPMC7238730
OpenAlexW3028146046

What OpenQuestion holds

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LicenceCC BY
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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 OpenQuestion graph.