An Exercise Program for Peritoneal Dialysis Patients in the United States: A Feasibility Study.

BACKGROUND: People with end-stage kidney disease receiving peritoneal dialysis (PD) are generally physically inactive and frail. Exercise studies in PD are scarce and currently there are no PD exercise programs in the United States. The primary objective of this study was to test the feasibility of a combined resistance and cardiovascular exercise program for PD patients under the care of a dedicated home dialysis center in the United States. STUDY DESIGN: Parallel randomized controlled feasibility study. SETTING & PARTICIPANTS: PD patients were recruited from a single center and randomly assigned to the intervention (exercise; n = 18) or control (nonexercise; n = 18) group. INTERVENTION: The intervention group received monthly exercise physiologist consultation, exercise prescription (resistance and aerobic exercise program using exercise bands), and 4 exercise support telephone calls over 12 weeks. The control group received standard care. OUTCOMES: The primary outcome was study feasibility as measured by eligibility rates, recruitment rates, retention rates, adherence rates, adverse events, and sustained exercise rates. Secondary outcome measures were changes in physical function (sit-to-stand test, timed-up-and-go test, and pinch-strength tests) and patient-reported outcome measures. RESULTS: From a single center with 75 PD patients, 57 (76%) were deemed eligible, resulting in a recruitment rate of 36 (63%) patients. Participants were randomly assigned into 2 groups of 18 (1:1). 10 patients discontinued the study (5 in each arm), resulting in 26 (72%) patients, 13 in each arm, completing the study. 10 of 13 (77%) intervention patients were adherent to the exercise program. A t test analysis of covariance found a difference between the treatment groups for the timed-up-and-go test (P = 0.04) and appetite (P = 0.04). No serious adverse events caused by the exercise program were reported. LIMITATIONS: Single center, no blinded assessors. CONCLUSIONS: A resistance and cardiovascular exercise program appears feasible and safe for PD patients. We recommend that providers of PD therapy consider including exercise programs coordinated by exercise professionals to reduce the physical deterioration of PD patients. FUNDING: None. TRIAL REGISTRATION: NCT03980795.

Challenges to enrollment and randomization of the Frequent Hemodialysis Network (FHN) Daily Trial.

BACKGROUND: The US National Institutes of Health (NIH) and Centers for Medicare and Medicaid Services (CMS) sponsored a randomized clinical trial comparing six versus three times per week in-center hemodialysis (the Frequent Hemodialysis Network [FHN] Daily Trial), to test the effects of frequent hemodialysis on an array of intermediate outcomes. Herein we report challenges to enrollment and randomization into the trial. METHODS: Screening and enrollment was tracked at all participating dialysis clinics and specific reasons for dropout after baseline assessment were recorded for all enrolled subjects. Reasons for consent refusal were recorded in a subset of (10 out of 65) sites. RESULTS: The trial screened 6276 hemodialysis patients on three times weekly hemodialysis in 65 hemodialysis clinics, 3481 (55%) were considered eligible for enrollment, and 3124 (90%) were approached for consent; 378 (12%) consented and 245 were randomized (65% of those enrolled). Prospective subjects chose not to participate primarily because of the anticipated time required for three extra treatments per week and the difficulties in following the protocol. CONCLUSIONS: Recruitment into the FHN Daily Trial proved challenging but the goal of 250 randomized subjects was almost met.

Determinants of left ventricular mass in patients on hemodialysis: Frequent Hemodialysis Network (FHN) Trials.

BACKGROUND: An increase in left ventricular mass (LVM) is associated with mortality and cardiovascular morbidity in patients with end-stage renal disease. METHODS AND RESULTS: The Frequent Hemodialysis Network (FHN) Daily Trial randomized 245 patients to 12 months of 6 times per week daily in-center hemodialysis or conventional hemodialysis; the FHN Nocturnal Trial randomized 87 patients to 12 months of 6 times per week nocturnal hemodialysis or conventional hemodialysis. The main cardiac secondary outcome was change in LVM. In each trial, we examined whether several predefined baseline demographic or clinical factors as well as change in volume removal, blood pressure, or solute clearance influenced the effect of frequent hemodialysis on LVM. In the Daily Trial, frequent hemodialysis resulted in a significant reduction in LVM (13.1 g; 95% CI, 5.0-21.3 g; P=0.002), LVM index (6.9 g/m(2); 95% CI, 2.4-11.3 g/m(2); P=0.003), and percent change in geometric mean of LVM (7.0%; 95% CI, 1.0%-12.6; P=0.02). Similar trends were noted in the Nocturnal Trial but did not reach statistical significance. In the Daily Trial, a more pronounced effect of frequent hemodialysis on LVM was evident among patients with left ventricular hypertrophy at baseline. Changes in LVM were associated with changes in blood pressure (conventional hemodialysis: R=0.28, P=0.01, daily hemodialysis: R=0.54, P<0.001) and were not significantly associated with changes in other parameters. CONCLUSIONS: Frequent in-center hemodialysis reduces LVM. The benefit of frequent hemodialysis on LVM may be mediated by salutary effects on blood pressure. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00264758.