Optimizing Cardiovascular Health and Physical Function in Hemodialysis Patients Through Volume Control and Exercise
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      This is a 12 month randomized clinical trial in which patients with renal failure undergoing
      maintenance hemodialysis (MHD) therapy will be placed on a volume reduction protocol that
      includes a novel low sodium dietary education program mediated by a lifestyle interventionist
      with significant collaboration from the existing clinic staff. Participating patients will be
      randomized to receive: 1) the volume control protocol alone (VC), or 2) the volume control
      protocol + physical activity and exercise counseling (VCE) from the lifestyle interventionist
      (LI). A research dietitian (RD), working in collaboration with the existing clinic RD, will
      develop a program to immerse clinics in a culture of sodium restriction. The research RD will
      train the LI and other clinic staff (nurses, technicians, etc) to help disseminate this
      program, modeled after the clinic-wide dissemination approach used in Izmir, Turkey (Dr.
      Ercan Ok). In addition, the LI will provide exercise and physical activity counseling to the
      participants randomized to the exercise group, utilizing a SCT-based approach. The
      Investigators hypothesize that mean arterial pressure will be reduced, and physical function
      increased, in all patients at 12 months, but the magnitude of these improvements will be
      greater in the VCE group.
    

Detailed description: 
      Patients with kidney failure require regular hemodialysis (HD) therapy 3-4 days per week to
      filter their blood and remove excess fluid. However, the dialysis process is inefficient, as
      it typically does not remove all of the fluid and waste products that accumulate in patients
      since their last treatment. This accumulation of excess fluid is called volume overload (VO).
      Chronic VO can have adverse effects on the heart and arteries, primarily by increasing blood
      pressure, eventually lead to enlargement of the heart and cardiac dysfunction (1-3). Some
      evidence also suggests that it adversely impacts patient's physical activity levels and
      function.

      Past research has shown that a patient's fluid volume can be controlled using 'volume
      control' strategies. These strategies involve progressively reducing a patient's
      post-dialysis body weight by slowly increasing the amount of fluid removed during each
      dialysis session (e.g., by removing an extra 200-300ml of fluid each session). Patient's
      dietary sodium intake is simultaneously restricted to control their thirst and to prevent
      fluid intake and accumulation between their treatments. Stringent volume control has been
      shown to improve cardiovascular health and reduce mortality (2-3), but is rarely/never
      practiced in U.S. dialysis clinics. Instead, patients in the U.S. are normally provided blood
      pressure or other medications to help mitigate the effects of excessive fluid accumulation
      between sessions. However, there is little evidence that these medications are efficacious,
      as most have no impact on fluid accumulation per se. Moreover, dietary sodium restriction, a
      principle component of successful volume reduction strategies, often requires comprehensive
      changes to an individual's diet due to the pervasive inclusion of salt in the U.S. food
      supply. Registered dietitians provide the majority of nutrition counseling to HD patients,
      but they lack the time to provide the level of care needed to sustain patient's dietary
      changes. As a result, chronic volume overload is a common problem in U.S. dialysis patients,
      as there are no established protocols for managing this problem other than through
      pharmacological interventions with no proven efficacy.

      The investigators are proposing a multifactorial intervention designed to improve HD
      patient's cardiovascular health and physical function. The intervention includes a novel
      volume control protocol that may be combined with exercise training to optimize the benefits
      of the volume control strategy. HD patients from selected clinics will be randomly assigned
      to: 1) volume control protocol (VC); or 2) VC + exercise training (VCE). The VC protocol will
      include 2 primary components: 1) a progressive increase in the amount of fluid removed during
      a patient's dialysis treatment (ultrafiltration volume) at the discretion of the patient's
      physician, and 2) a dietary intervention to improve patient's food choices, focused on
      reducing the intake of fast and processed foods that are high in sodium, as well as
      phosphorus additives that may also have damaging effects on the heart, arteries, and bone.
      The dietary intervention will involve training the existing clinic staff to help deliver
      better and more consistent nutritional messages to their patients, to supplement the work of
      the existing clinic dietitian.

      Patients randomized to exercise group (VCE) will receive the VC intervention in addition to a
      personalized exercise training and physical activity prescription from a "lifestyle
      interventionist" (LI). This will include exercise during dialysis treatment, as well as
      counseling on how to increase physical activity levels outside of the clinic - namely at home
      or in the community.

      The LI will also help deliver the nutritional education component of the VC protocol. As most
      HD clinics typically employ one or more full time registered dietitians, the LI will work
      closely with them to support their work. The LI will focus on basic nutrition messages
      including decreasing the intake of fast and processed foods, ensuring regular meals, and
      adequate protein intake. This education will be conducted according to the Fresenius Tech
      Talk model. Short in-services will be held with clinic staff to educate them on general
      nutrition principles. Staff will be encouraged to incorporate these talking points into
      patient conversations. Outcomes will be evaluated by the LI at baseline, and after 6 and 12
      months. Primary outcomes include mean arterial blood pressure and physical function.
      Secondary outcomes include: hospitalization rates, cardiovascular function, dialysis
      compliance, fall incidence, and blood pressure medication prescription.

      This study will provide novel information regarding the effects of a novel volume control
      strategy and exercise training on physical function and cardiovascular health in HD patients.
      Results from this study will enable nephrologists to make more informed decisions regarding
      the extent to which this low-cost treatment strategy should be included as a component of the
      standard care in their clinics. Ultimately, this could lead to greater use of this treatment
      strategy and result in significant improvements in the health and quality of life of this
      critically ill patient population.
    

Intervention name(s): Volume Control; Volume Control + Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Persistent reduction in post-dialysis weight and dietary sodium restriction; Volume reduction intervention and comprehensive exercise counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Nutrition; Hemodialysis