Dataset Information

Effect of hemodiafiltration on measured physical activity: primary results of the HDFIT randomized controlled trial.

ABSTRACT:

Background

Dialysis patients are typically inactive and their physical activity (PA) decreases over time. Uremic toxicity has been suggested as a potential causal factor of low PA in dialysis patients. Post-dilution high-volume online hemodiafiltration (HDF) provides greater higher molecular weight removal and studies suggest better clinical/patient-reported outcomes compared with hemodialysis (HD).

Methods

HDFIT was a randomized controlled trial at 13 clinics in Brazil that aimed to investigate the effects of HDF on measured PA (step counts) as a primary outcome. Stable HD patients (vintage 3-24 months) were randomized to receive HDF or high-flux HD. Treatment effect of HDF on the primary outcome from baseline to 3 and 6 months was estimated using a linear mixed-effects model.

Results

We randomized 195 patients (HDF 97; HD 98) between August 2016 and October 2017. Despite the achievement of a high convective volume in the majority of sessions and a positive impact on solute removal, the treatment effect HDF on the primary outcome was +538 [95% confidence interval (CI) -330 to 1407] steps/24 h after dialysis compared with HD, and was not statistically significant. Despite a lack of statistical significance, the observed size of the treatment effect was modest and driven by steps taken between 1.5 and 24.0 h after dialysis, in particular between 20 and 24 h (+197 steps; 95% CI -95 to 488).

Conclusions

HDF did not have a statistically significant treatment effect on PA 24 h following dialysis, albeit effect sizes may be clinically meaningful and deserve further investigation.

SUBMITTER: Pecoits-Filho R

PROVIDER: S-EPMC8160948 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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Publications

Effect of hemodiafiltration on measured physical activity: primary results of the HDFIT randomized controlled trial.

Pecoits-Filho Roberto R Larkin John J Poli-de-Figueiredo Carlos Eduardo CE Cuvello-Neto Américo Lourenço AL Barra Ana Beatriz Lesqueves ABL Gonçalves Priscila Bezerra PB Sheth Shimul S Guedes Murilo M Han Maggie M Calice-Silva Viviane V de Castro Manuel Carlos Martins MCM Kotanko Peter P de Moraes Thyago Proenca TP Raimann Jochen G JG Canziani Maria Eugenia F MEF

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association 20210501 6

<h4>Background</h4>Dialysis patients are typically inactive and their physical activity (PA) decreases over time. Uremic toxicity has been suggested as a potential causal factor of low PA in dialysis patients. Post-dilution high-volume online hemodiafiltration (HDF) provides greater higher molecular weight removal and studies suggest better clinical/patient-reported outcomes compared with hemodialysis (HD).<h4>Methods</h4>HDFIT was a randomized controlled trial at 13 clinics in Brazil that aimed ...[more]

PMID: 33160281

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Project description:BackgroundWe investigated preoperative physical activity (PA) and sedentary behaviour (SB) in patients scheduled for elective cardiac procedures and compared them with population-based sample of Finnish adults.MethodsCardiac patients (n = 139) undergoing cardiac operations carried a triaxial accelerometer for seven days during the month before the procedure. Patients were categorised into four groups according to the procedure: percutaneous coronary intervention or coronary angiography (PCI-CA), coronary artery bypass grafting (CABG), aortic valve replacement (AVR) and mitral valve surgery (MVS). The raw accelerometer data was analyzed with dedicated algorithms to determine metabolic equivalents (METs, 3.5 mL/kg/min of oxygen consumption) of PA. The intensity of PA was divided into two categories: light (LPA, 1.5-2.9 METs) and moderate-to-vigorous (MVPA, ≥ 3.0 METs), while SB represented intensity < 1.5 MET without movements. SB and PA were described as daily means and accumulation from different bout lengths. Daily standing, steps and mean and peak MET-values were calculated. The results were compared between the patient groups and against the reference group from a population-based study FinFit2017.ResultsCardiac patients had fewer daily steps than the FinFit population (p = 0.01), and less SB accumulating from < 20 min bouts (p = 0.002) but more from 20 to 60 min bouts (p = 0.002). Particularly, CABG group had less daily MVPA (p = 0.002) and MVPA accumulating from > 10 min bouts (p < 0.001) than the FinFit population.ConclusionsWe found large differences in PA and SB between the patient groups and the FitFit population, CABG group having the worst activity profile. Also, the variation within the patient groups was wide, which should be considered to individualise the rehabilitation programs postoperatively. Trial registration clinicaltrials.gov (NCT03470246). Registered 19 March 2018, https://clinicaltrials.gov/ct2/show/NCT03470246.

Project description: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 ).

Project description:BackgroundThe beneficial effects of physical activity (PA) for older adults are well known. However, few older adults reach the health guideline of 150 min per week of moderate-to-vigorous PA (MVPA). Electronic health (eHealth) interventions are effective in increasing PA levels in older adults in the short term but, rarely, intermediate-term effects after a period without the support of a website or an app have been examined. Furthermore, current theory-based interventions focus mainly on preintentional determinants, although postintentional determinants should also be included to increase the likelihood of successful behavior change.ObjectiveThis study aimed to investigate the effect of the theory-based eHealth intervention, MyPlan 2.0, focusing on pre- and postintentional determinants on both accelerometer-based and self-reported PA levels in older Belgian adults in the short and intermediate term.MethodsThis study was a randomized controlled trial with three data collection points: baseline (N=72), post (five weeks after baseline; N=65), and follow-up (three months after baseline; N=65). The study took place in Ghent, and older adults (aged ≥65 years) were recruited through a combination of random and convenience sampling. At all the time points, participants were visited by the research team. Self-reported domain-specific PA was assessed using the International Physical Activity Questionnaire, and accelerometers were used to objectively assess PA. Participants in the intervention group got access to the eHealth intervention, MyPlan 2.0, and used it independently for five consecutive weeks after baseline. MyPlan 2.0 was based on the self-regulatory theory and focused on both pre- and postintentional processes to increase PA. Multilevel mixed-models repeated measures analyses were performed in R (R Foundation for Statistical Computing).ResultsSignificant (borderline) positive intervention effects were found for accelerometer-based MVPA (baseline-follow-up: intervention group +5 min per day and control group -5 min per day; P=.07) and for accelerometer-based total PA (baseline-post: intervention group +20 min per day and control group -24 min per day; P=.05). MyPlan 2.0 was also effective in increasing self-reported PA, mainly in the intermediate term. A positive intermediate-term intervention effect was found for leisure-time vigorous PA (P=.02), moderate household-related PA (P=.01), and moderate PA in the garden (P=.04). Negative intermediate-term intervention effects were found for leisure-time moderate PA (P=.01) and cycling for transport (P=.07).ConclusionsThe findings suggest that theory-based eHealth interventions focusing on pre- and postintentional determinants have the potential for behavior change in older adults. If future studies including larger samples and long-term follow-up can confirm and clarify these findings, researchers and practitioners should be encouraged to use a self-regulation perspective for eHealth intervention development.Trial registrationClinicaltrials.gov NCT03194334; https://clinicaltrials.gov/ct2/show/NCT03783611.

Project description:BackgroundLimited evidence suggests that physical activity may prevent frailty and associated negative outcomes in older adults. Definitive data from large long-term randomized trials are lacking.ObjectiveTo determine whether a long-term, structured, moderate-intensity physical activity program is associated with a lower risk for frailty and whether frailty status alters the effect of physical activity on the reduction in major mobility disability (MMD) risk.DesignMulticenter, single-blind, randomized trial.Setting8 centers in the United States.Participants1635 community-dwelling adults, aged 70 to 89 years, with functional limitations.InterventionA structured, moderate-intensity physical activity program incorporating aerobic, resistance, and flexibility activities or a health education program consisting of workshops and stretching exercises.MeasurementsFrailty, as defined by the SOF (Study of Osteoporotic Fractures) index, at baseline and 6, 12, and 24 months, and MMD, defined as the inability to walk 400 m, for up to 3.5 years.ResultsOver 24 months of follow-up, the risk for frailty (n = 1623) was not statistically significantly different in the physical activity versus the health education group (adjusted prevalence difference, -0.021 [95% CI, -0.049 to 0.007]). Among the 3 criteria of the SOF index, the physical activity intervention was associated with improvement in the inability to rise from a chair (adjusted prevalence difference, -0.050 [CI, -0.081 to -0.020]). Baseline frailty status did not modify the effect of physical activity on reducing incident MMD (P for interaction = 0.91).LimitationFrailty status was neither an entry criterion nor a randomization stratum.ConclusionA structured, moderate-intensity physical activity program was not associated with a reduced risk for frailty over 2 years among sedentary, community-dwelling older adults. The beneficial effect of physical activity on the incidence of MMD did not differ between frail and nonfrail participants.Primary funding sourceNational Institute on Aging, National Institutes of Health.

Dataset Information

Effect of hemodiafiltration on measured physical activity: primary results of the HDFIT randomized controlled trial.

Background

Methods

Results

Conclusions

Publications

Effect of hemodiafiltration on measured physical activity: primary results of the HDFIT randomized controlled trial.

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