Exercise and Vascular Parameters in Hemodialysis

NCT02757456 | Completed

• 1 other identifier: 12-309-GEN
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Disease

Keywords

exercise; hemodialysis; pulse wave velocity; micro RNAs

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Gait speed

  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.

  at 24 weeks and 48 weeks

Secondary Outcomes (3)

• Change from Baseline Pulse wave velocity (PWV)

  at 24 weeks and 48 weeks

• Change from Baseline Pulse wave analysis

  at 24 and 48 weeks

• Change from baseline Rand survey

  at 24 weeks and 48 weeks

Other Outcomes (3)

• change from baseline micro RNA levels

  at 24 weeks and 48 weeks

• change from baseline Brain Natuiretic Peptide

  at 24 weeks and 48 weeks

• change from baseline troponin levels

  at 24 weeks and 48 weeks

Study Arms (2)

Aerobic Exercise program

OTHER

Intervention of aerobic exercise

Behavioral: Aerobic Exercise program

Control

OTHER

no aerobic exercise program

Other: Control

Interventions

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.

Aerobic Exercise program

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sameena Iqbal: lead

Study Sites (2)

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Sameena Iqbal

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD FRCP MSc.

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: May 2, 2016
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2016
• Last Updated: April 6, 2017

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)