NCT02757456

Exercise and Vascular Parameters in Hemodialysis

Aerobic Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Sameena Iqbal · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
BEHAVIORAL	Aerobic Exercise program	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.
OTHER	Control	No aerobic exercise is offered but baseline and end of study testing of the outcomes occur

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-11-01
• Completion: 2016-02-01
• First posted: 2016-05-02
• Last updated: 2017-04-06

Locations

2 sites across 1 country: Canada