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Completed

NCT Number: NCT02757456

Exercise and Vascular Parameters in Hemodialysis

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.

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Key information

Conditions

Cardiovascular Disease Behavior Cardiovascular Diseases Motor Activity

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal General Hospital, Montreal, Quebec, Canada

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About this study

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:

  • change in gait speed before and after the exercise program
  • change in pulse wave velocity before and after the exercise program
  • change in BNP, blood pressure, dialysis ultrafiltration, hemoglobin, micro RNAs before and after the exercise program

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, aged 18-95 years
  • Able to comply with the study procedures and medication
  • Written informed consent given
  • On a stable in-center hemodialysis regimen (at least 3 times per week) for ≥ 12 weeks prior to recruitment
  • Cardiac evaluation within the year with adequate cardiac function to be able to undergo the exercise program

Exclusion criteria

  • Participation in any clinical trial using an investigational product or device during the 30 days preceding recruitment
  • Any physical or psychological disability that would impact study participation, such as severe cerebrovascular disease (ie. hemiparesis, cerebellar ataxia, etc.) or dementia
  • Serum iPTH > 250 pmol/L within 30 days prior to screening visit
  • Dysrhythmia or severe cardiac disease: CHF Class III-IV; unstable cardiovascular diagnosis (for example MI, CABG, PTCA, CVA, and TIA) within 90 days prior to recruitment
  • Severe peripheral vascular disease
  • Severe hyperkalemia (>6.5 mmol/L) consistently for the last 2 weeks
  • Current active cancer (excluding basal cell carcinoma of the skin)
  • Poorly controlled hypertension (systolic > 180mmHg or diastolic > 100mmHg) within 4 weeks prior to recruitment
  • Anticipated live donor kidney transplant or any other planned major surgery over the study duration
  • History of poor adherence to hemodialysis or medical regimen
  • Any disease or condition, physical or psychological that, in the opinion of the investigator, would compromise the safety of the subject or the likelihood of achieving reliable results or increase the likelihood of the subject being withdrawn

Treatment and study plan

Aerobic Exercise Program

Behavioral

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.

Control

Other

No aerobic exercise is offered but baseline and end of study testing of the outcomes occur

Primary outcomes

  1. Change from Baseline in Gait speed

    Time frame: at 24 weeks and 48 weeks

    The gait speed will be measured with a timer (in seconds) as the subject will be asked to walk a 10 foot or 3 meter course and back as quickly as possible. Two readings will be taken and the average will be recorded.

Secondary outcomes

  1. Change from Baseline Pulse wave velocity (PWV)

    Time frame: at 24 weeks and 48 weeks

    PWV measurements will be performed between the carotid and femoral artery sites, to primarily measure the stiffness of the aorta. A 3-lead ECG will be used in conjunction with a tonometer to measure the pressure pulse waveform sequentially in the two peripheral artery sites

  2. Change from Baseline Pulse wave analysis

    Time frame: at 24 and 48 weeks

    Wave Reflections and Arterial Stiffness. Analysis of the systolic part of the central pressure waveform will be performed to evaluate PWV and the LV afterload. The main indices that were described above (in hemodynamic measurements) will be obtained by aortic PWA.

  3. Change from baseline Rand survey

    Time frame: at 24 weeks and 48 weeks

    RAND 36-item survey will be used to assess physical functioning and fatigue. This survey has been validated in the Hemodialysis population. The survey consists of 36 items and takes approximately 5-10 minutes to complete.

Other outcomes

  1. change from baseline micro RNA levels

    Time frame: at 24 weeks and 48 weeks

    micro RNAs (21, 126, 133, 146a, 221/222 and 210): blood sample will be taken before initiation of dialysis week of baseline measurements and end of study.

  2. change from baseline Brain Natuiretic Peptide

    Time frame: at 24 weeks and 48 weeks

    Brain Natuiretic Peptide: measure before initiation of dialysis at baseline and at the end of study period.

  3. change from baseline troponin levels

    Time frame: at 24 weeks and 48 weeks

    to assess myocardial injury during dialysis at baseline and at the end of the study

Sponsors and collaborators

Lead sponsor

Sameena Iqbal

Other

Registry information

Official study title

Aerobic Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 2, 2016
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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