Exercise and Vascular Parameters in Hemodialysis
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Arterial calcification is very common in the incident hemodialysis population, ranging
      71-83%.Given that cardiovascular disease is a major cause of mortality in the hemodialysis
      population, medial arterial calcification may contribute through increased risk of sudden
      death and congestive heart failure. Applanation tonometry is the method of choice to measure
      pulse wave velocity and pulse wave analysis. The primary objective will be to assess the
      effect of a 16 week exercise program on aortic pulse wave velocity as the vascular parameter
      and gait speed as the physical functioning parameter. The secondary objectives will assess
      the effect of the exercise program on ultrafiltration rates, weight, SBP, DBP, BNP,
      hsTroponin, serum calcium, phosphate, albumin, glucose, LDL, HDL, TG, glycated hemoglobin,
      hemoglobin, CRP, micro RNAs (21, 126, 133, 146a, 221/222 and 210) and hospitalizations.
    

Detailed description: 
      The investigators propose a pilot project to assess the effect of a 16 week aerobic exercise
      program on arterial stiffness and cardiovascular risk in the hemodialysis population. The
      primary objective will be to assess the effect of a 16 week exercise program on aortic pulse
      wave velocity as the vascular parameter and gait speed as the physical functioning parameter.
      The secondary objectives will assess the effect of the exercise program on ultrafiltration
      rates, weight, SBP, DBP, BNP, hsTroponin, serum calcium, phosphate, albumin, glucose, LDL,
      HDL, TG, glycated hemoglobin, hemoglobin, CRP, micro RNAs (21, 126, 133, 146a, 221/222 and
      210) and hospitalizations.

      Study Design:

      Randomized-controlled study of end stage renal disease patients between the age of 18 and 90
      years to assess the effect of exercise on arterial stiffness. Our aim is to have 23 patients
      in both groups. The study period will be 24 weeks-4 weeks for recruitment, 16 weeks for the
      intervention and 4 weeks for data collection and analysis. The protocol will be submitted to
      the MUHC Research Ethics Board.

      The following outcomes are of interest:

        1. change in gait speed before and after the exercise program

        2. change in pulse wave velocity before and after the exercise program

        3. change in BNP, blood pressure, dialysis ultrafiltration, hemoglobin, micro RNAs before
           and after the exercise program
    

Intervention name(s): Aerobic Exercise program; Control
Intervention type(s): Behavioral; Other
Intervention description(s): The 16-week program will consist of aerobic-type steady-state or interval exercises using a pedals attachable to the dialysis chairs. The purpose will be to slowly increase exercise duration by 5 minute increments to reach the goal of 30 min/treatment. The exercise program during hemodialysis sessions will contain a combination of aerobic and flexibility exercises, about 30 minutes of cycling with 10 minutes of warm up/stretching exercises and 10-15 minutes cool down. The frequency of exercise will be three sessions a week, during the first hour of dialysis treatment for the duration of 16 weeks. Blood pressure and heart continuous monitoring will be carried out during the exercise program. Exercise log sheets will be filled for each session for the 16 weeks.; No aerobic exercise is offered but baseline and end of study testing of the outcomes occur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: exercise; hemodialysis; pulse wave velocity; micro RNAs