Evidence map›Paper›PMID 34930408›Full record

ArticleTrials2021

Comparison of intradialytic neuromuscular electrical stimulation and oral nutritional supplements in hemodialysis patients: study protocol for a multicenter, parallel-group, randomized controlled trial in Korea.

Mi-Yeon Yu, Jae Hyeon Park, Yong Chul Kim, Jae Yoon Park, Ran-Hui Cha

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 79% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

5 authors at 4 institutions in 1 country.

Mi-Yeon YuDepartment of Internal Medicine, Hanyang University Guri Hospital, Guri, Gyeonggi-do, Republic of Korea.
Jae Hyeon ParkDepartment of Rehabilitation Medicine, Hanyang University Guri Hospital, Guri, Gyeonggi-do, Republic of Korea.
Yong Chul KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Jae Yoon ParkDepartment of Internal Medicine, Dongguk University Ilsan Hospital, Ilsan, Gyeonggi-do, Republic of Korea.
Ran-Hui ChaDepartment of Internal Medicine, National Medical Center, 245, Eulji-ro, Jung-gu, Seoul, 04564, Republic of Korea. reginaprayer@gmail.com.ORCID http://orcid.org/0000-0003-2783-2600
Dongguk University Ilsan Hospital · KREulji University · KRHanyang University Guri Hospital · KRSeoul National University Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe prevalence of sarcopenia increases as renal function decreases, and a considerable number of hemodialysis (HD) patients have sarcopenia. Exercise and nutritional support are established interventions to prevent and treat sarcopenia. Recently, many studies evaluating intradialytic neuromuscular electrical stimulation (NMES) showed improvement of muscular strength and mass, functional capacity, and quality of life (QOL). However, there has been no research about the effect of simultaneous nutritional support and NMES in HD patients.

methodsThis is a 12-week, randomized controlled, parallel-group, multicenter trial of intradialytic NMES and protein supplementation for HD patients. Seventy-two patients receiving HD will be randomly assigned in a 1:1:1:1 ratio to control, intradialytic NMES only, protein supplementation only, and intradialytic NMES combined with protein supplementation groups. NMES will be delivered to a total of four areas of the bilateral vastus medialis and vastus lateralis using a 4-channel NMES instrument. A total of 25 g of protein supplements will be provided at the beginning of every dialysis session or after the NMES. The primary endpoint is the difference of hand grip and leg muscle strength at 12 weeks among 4 treatment groups. Secondary endpoints include muscle mass, physical performances, and questionnaires about QOL and physical activity. DISCUSSION: In this study, we will evaluate the differential effectiveness of nutritional support and NMES during HD on muscle strength, muscle mass, physical function, and QOL. We expect that this study can provide guidelines for a new therapeutic option for HD patients who are unable or hesitant to exercise. Furthermore, this option can offer an opportunity to improve the physical function, QOL, and prognosis of HD patients.

trial registrationClinical Research Information Service (CRIS), Korea, KCT0005573 . Retrospectively registered on 03 November 2020.

Indexed as

Hand StrengthQuality of LifeElectric StimulationHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicRenal DialysisRepublic of KoreaHemodialysisMuscle strengthNeuromuscular electrical stimulationPhysical functionProtein supplementationQuality of life

Identifiers

PMID34930408
PMCPMC8686339
OpenAlexW4200044242

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.