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Design and methodology of the impact of HemoDiaFIlTration on physical activity and self-reported outcomes: a randomized controlled trial (HDFIT trial) in Brazil.

ABSTRACT: BACKGROUND:End stage renal disease (ESRD) patients require a renal replacement therapy (RRT) to filter accumulated toxins and remove excess water, which are associated with impaired physical function. Hemodialysis (HD) removes middle-molecular weight (MMW) toxins less efficiently compared to hemodiafiltration (HDF); we hypothesized HDF may improve physical function. We detailed the design and methodology of the HDFIT protocol that is testing whether changing from HD to HDF effects physical activity levels and various outcomes. METHODS:HDFIT is a prospective, multi-center, unblinded, randomized control trial (RCT) investigating the impact of dialysis modality (HDF verses HD) on objectively measured physical activity levels, self-reported quality of life, and clinical/non-clinical outcomes. Clinically stable patients with HD vintage of 3 to 24?months without any severe limitation ambulation were recruited from sites throughout southern Brazil. Eligible patients were randomized in a 1:1 ratio to either: 1) be treated with high volume online HDF for 6?months, or 2) continue being treated with high-flux HD. This study includes run-in and randomization visits (baseline), 3- and 6-month study visits during the interventional period, and a 12-month observational follow up. The primary outcome is the difference in the change in steps per 24?h on dialysis days from baseline to the 6-month follow up in patients treated with HDF versus HD. Physical activity is being measured over one week at study visits with the ActiGraph ( www.actigraphcorp.com ). For assessment of peridialytic differences during the dialysis recovery period, we will analyze granular physical activity levels based on the initiation time of HD on dialysis days, or concurrent times on non-dialysis days and the long interdialytic day. DISCUSSION:In this manuscript, we provide detailed information about the HDFIT study design and methodology. This trial will provide novel insights into peridialytic profiles of physical activity and various self-reported, clinical and laboratory outcomes in ESRD patients treated by high volume online HDF versus high-flux HD. Ultimately, this investigation will elucidate whether HDF is associated with patients having better vitality and quality of life, and less negative outcomes as compared to HD. TRIAL REGISTRATION:Registered on ClinicalTrials.gov on 20 April 2016 ( NCT02787161 ).

SUBMITTER: Pecoits-Filho R

PROVIDER: S-EPMC6425582 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Design and methodology of the impact of HemoDiaFIlTration on physical activity and self-reported outcomes: a randomized controlled trial (HDFIT trial) in Brazil.

Pecoits-Filho Roberto R Larkin John W JW Poli-de-Figueiredo Carlos Eduardo CE Cuvello Neto Américo Lourenço AL Barra Ana Beatriz AB Canhada Sinaia S de Campos Ludimila Guedim LG Woehl Juliane J Gonçalves Priscila Bezerra PB Han Hao H de Moraes Thyago Proença TP Raimann Jochen G JG Canziani Maria Eugenia F MEF

BMC nephrology 20190320 1

<h4>Background</h4>End stage renal disease (ESRD) patients require a renal replacement therapy (RRT) to filter accumulated toxins and remove excess water, which are associated with impaired physical function. Hemodialysis (HD) removes middle-molecular weight (MMW) toxins less efficiently compared to hemodiafiltration (HDF); we hypothesized HDF may improve physical function. We detailed the design and methodology of the HDFIT protocol that is testing whether changing from HD to HDF effects physic ...[more]

PMID: 30894141

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Project description:To provide clinical guidance in hearing aid prescription for older adults with presbycusis, we investigated differences in self-reported hearing abilities and hearing aid effectiveness for premium or basic hearing aid users. Secondly, as an explorative analysis, we investigated if differences in gain prescription verified with real-ear measurements explain differences in self-reported outcomes. The study was designed as a randomized controlled trial in which the patients were blinded towards the purpose of the study. In total, 190 first-time hearing aid users (>60 years of age) with symmetric bilateral presbycusis were fitted with either a premium or basic hearing aid. The randomization was stratified on age, sex, and word recognition score. Two outcome questionnaires were distributed: the International Outcome Inventory for Hearing Aids (IOI-HA) and the short form of the Speech, Spatial, and Qualities of Hearing Scale (SSQ-12). In addition, insertion gains were calculated from real-ear measurements at first-fit for all fitted hearing aids. Premium hearing aid users reported 0.7 (95%CI: 0.2; 1.1) scale points higher total SSQ-12 score per item and 0.8 (95%CI: 0.2; 1.4) scale points higher speech score per item, as well as 0.6 (95%CI: 0.2; 1.1) scale points higher qualities score compared to basic-feature hearing aid users. No significant differences in reported hearing aid effectiveness were found using the IOI-HA. Differences in the prescribed gain at 1 and 2 kHz were observed between premium and basic hearing aids within each company. Premium-feature devices yielded slightly better self-reported hearing abilities than basic-feature devices, but a statistically significant difference was only found in three out of seven outcome variables, and the effect was small. The generalizability of the study is limited to community-dwelling older adults with presbycusis. Thus, further research is needed for understanding the potential effects of hearing aid technology for other populations. Hearing care providers should continue to insist on research to support the choice of more costly premium technologies when prescribing hearing aids for older adults with presbycusis. Clinical Trial Registration: https://register.clinicaltrials.gov/, identifier NCT04539847.

Dataset Information

Design and methodology of the impact of HemoDiaFIlTration on physical activity and self-reported outcomes: a randomized controlled trial (HDFIT trial) in Brazil.

Publications

Design and methodology of the impact of HemoDiaFIlTration on physical activity and self-reported outcomes: a randomized controlled trial (HDFIT trial) in Brazil.

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