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

Roberto Pecoits-Filho, John W Larkin, Carlos Eduardo Poli-de-Figueiredo, Américo Lourenço Cuvello Neto, Ana Beatriz Barra, Sinaia Canhada, Ludimila Guedim de Campos, Juliane Woehl, Priscila Bezerra Gonçalves, Hao Han, Thyago Proença de Moraes, Jochen G Raimann, Maria Eugenia F Canziani, HDFIT Study Investigators, Ana Claudia Dambiski, Thaylane Amanda de Souza, Daniela Ponce, Edwa Maria Bucuvic, Luciana Menin Ferreira, Wanderson de Souza Carvalho, Jorge Paulo Strogoff de Matos, Esther Oliveria Silva, Manuel Carlos Martins de Castro, Celina de Fátima E Silva, Maria Eugenia F Canziani, Silvia R Manfredi, Katia Santos, Ana Paula Fonseca Correia, Giovani Gadonski, Adriana Conti, Inah Pecly, Camille Souza Paixão, Viviane Calice-Silva, Simone Ribeiro, Lizia Regina Ribeiro Caldeira, Adailto Santos, Rosilene Motta Elias, Andreia Barbosa Dos Santos, Américo Lourenço Cuvello-Neto, Amanda Monteiro Virolli, Roberto Pecoits-Filho, John W Larkin, Carlos Eduardo Poli-de-Figueiredo, Américo Lourenço Cuvello Neto, Ana Beatriz Barra, Sinaia Canhada, Ludimila Guedim de Campos, Juliane Woehl, Priscila Bezerra Gonçalves, Hao Han, Thyago Proença de Moraes, Jochen G Raimann, Maria Eugenia F Canziani, HDFIT Study Investigators, Ana Claudia Dambiski, Thaylane Amanda de Souza, Daniela Ponce, Edwa Maria Bucuvic, Luciana Menin Ferreira, Wanderson de Souza Carvalho, Jorge Paulo Strogoff de Matos, Esther Oliveria Silva, Manuel Carlos Martins de Castro, Celina de Fátima E Silva, Maria Eugenia F Canziani, Silvia R Manfredi, Katia Santos, Ana Paula Fonseca Correia, Giovani Gadonski, Adriana Conti, Inah Pecly, Camille Souza Paixão, Viviane Calice-Silva, Simone Ribeiro, Lizia Regina Ribeiro Caldeira, Adailto Santos, Rosilene Motta Elias, Andreia Barbosa Dos Santos, Américo Lourenço Cuvello-Neto, Amanda Monteiro Virolli

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 ).

Keywords: Accelerometer; Activities of daily living (ADL); Dialysis recovery; End stage renal disease (ESRD); Hemodiafiltration (HDF); Hemodialysis (HD); Physical activity; Steps per day.

Conflict of interest statement

Ethics approval and consent to participate

This trial is being conducted under a protocol approved by the Pontifícia Universidade Católica do Paraná ERB with the central application tracking number 54926916.7.1001.0020 and ERB approval number 1.538.784. All patients provided written informed consent prior to participation in the trial.

Consent for publication

Not applicable.

Competing interests

RPF is employed by Pontifícia Universidade Católica do Paraná, an employed by Arbor Research Collaborative for Health, a recipient of a scholarship from the Brazilian Council for Research (CNPq), and receives research grants, consulting fees, and honoraria from Baxter Healthcare and Fresenius Medical Care. CEPF, ALCN receives consulting fees and speaker honorarium from Fresenius Medical Care. ABB is an employee of Fresenius Medical Care Brazil. JWL, HH, JGR are employees of Fresenius Medical Care North America, or the subsidiary company Renal Research Institute. JWL is a student at Pontifícia Universidade Católica do Paraná. MEFC is employed by Federal University of São Paulo, is a recipient of a scholarship from the Brazilian Council for Research (CNPq), and receives research grants, consulting fees, and honoraria from Baxter Healthcare and Fresenius Medical Care. All other authors declare no relevant conflicts of interest.

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Figures

Fig. 1
Fig. 1
Schematic of the HDFIT Study Design
Fig. 2
Fig. 2
Schematic of Slicing of Physical Activity Data on Dialysis Days
Fig. 3
Fig. 3
Schematic of Slicing of Physical Activity Data on Non-Dialysis Days
Fig. 4
Fig. 4
Schematic of Slicing of Physical Activity Data on Long Interdialytic Day

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