Exercise and Vascular Parameters in Hemodialysis

NCT ID: NCT02757456

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-02-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Aerobic Exercise program

Intervention of aerobic exercise

Group Type: OTHER

Aerobic Exercise program

Intervention Type: 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

no aerobic exercise program

Group Type: OTHER

Control

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

Control

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male or female, aged 18-95 years

2. Able to comply with the study procedures and medication

3. Written informed consent given

4. On a stable in-center hemodialysis regimen (at least 3 times per week) for ≥ 12 weeks prior to recruitment

5. Cardiac evaluation within the year with adequate cardiac function to be able to undergo the exercise program

Exclusion Criteria

1. Participation in any clinical trial using an investigational product or device during the 30 days preceding recruitment

2. Any physical or psychological disability that would impact study participation, such as severe cerebrovascular disease (ie. hemiparesis, cerebellar ataxia, etc.) or dementia

3. Serum iPTH > 250 pmol/L within 30 days prior to screening visit

4. 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

5. Severe peripheral vascular disease

6. Severe hyperkalemia (>6.5 mmol/L) consistently for the last 2 weeks

7. Current active cancer (excluding basal cell carcinoma of the skin)

8. Poorly controlled hypertension (systolic > 180mmHg or diastolic > 100mmHg) within 4 weeks prior to recruitment

9. Anticipated live donor kidney transplant or any other planned major surgery over the study duration

10. History of poor adherence to hemodialysis or medical regimen

11. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sameena Iqbal

OTHER

Sponsor Role: lead

Responsible Party

Sameena Iqbal

MD FRCP MSc.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sameena Iqbal

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

Royal Victoria Hospital

Montreal, Quebec, Canada

Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

12-309-GEN

Identifier Type: -

Identifier Source: org_study_id