The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients

The purpose of this study is to explore the impact of an intradialytic exercise program on functional capacity, aerobic capacity, strength, quality of life, depression, hospitalizations and intradialytic episodes of hypotension. The investigators would also like to look at the impact of exercise training over twelve weeks on hemoglobin levels as well as the clearance of potassium, phosphate and urea. Our hypothesis is that the above mentioned outcomes will positively improve over the twelve week intervention.

Study Overview

• Status: Completed
• Conditions: End Stage Kidney Disease
• Intervention / Treatment: Other: exercise

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2L 2J8
      • Northwest Dialysis Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cardiac and hemodynamic stability
• Absence of severe musculoskeletal impairment
• Increased musculoskeletal weakness
• Vital signs within normal range for exercise
• Desire/motivated to exercise
• Clearance from nephrologist and Kinesiologist

Exclusion Criteria:

• Compromised cardiac profiles
• Hemodynamic instability
• Severe bone disease
• Medical conditions which contraindicate exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intradialytic exercise; baseline data prior to starting exercise program will be obtained and then compared to the data after 12 weeks of an intradialtyic biking program	Other: exercise; 12 weeks of intradialytic biking at Borg intensity 3 - 4 for 15 to 60 minutes on each dialysis run; Other Names: intradialytic exercise; intradialytic biking; biking on hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Capacity	Functional capacity is measured by the DASI score which gives an estimated V02 peak in ml/min/kg. The difference between the mean score at baseline and 12 weeks will be determined.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerobic capacity	Aerobic capacity is measured as a function of the DASI score	12 weeks
Strength	Strength is determined as bilateral hand grip strength (measured in kg) as well as by the 30 second sit to stand test(the number of repetitions achieved in 30 seconds). These measures are obtained at baseline and again at 12 weeks.	12 weeks
Quality of life	The KDQOL- SF36 will be used to measure the quality of life at baseline and again at 12 weeks.	12 weeks
Hospitalizations	The number and rate of hospitalizations will be determined prior to exercise start and during the 12 week exercise program. Length of stay is also tracked.	12 weeks
Hypotension	Intradialytic hypotension, defined as a drop in systolic blood pressure (SBP) of 20 mmHg for patients with pre-dialysis blood pressure > 100 mmHg or a drop in SBP of 10 mmHg for patients with pre-dialysis blood pressure < = 90 mmHg. IDH with patient symptoms and nursing interventions will be obtained as well.	12 weeks
Hemoglobin levels	The baseline hemoglobin and hemoglobin at 12 weeks will be tracked.	12 weeks
Potassium levels	The baseline potassium and potassium at 12 weeks as well as the K gradient (pre -dialysis - dialysate K level)will be monitored.	12 weeks
Urea removal	The baseline and 12 week pre and post dialysis urea levels will be monitored.	12 weeks
Phosphate levels	The baseline and 12 week pre-dialysis phosphate levels will be tracked.	12 weeks
Bioimpedance derived volume and body mass determinations	In a small subset of patients (n=10) the bioimpedance derived fluid compartments (ECF, ICF, E:I ratio) and fat free body mass will be determined at both baseline and 12 weeks.	12 weeks

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Jennifer MacRae, University of Calgary

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 27, 2013
• First Submitted That Met QC Criteria: June 13, 2013
• First Posted (Estimate): June 14, 2013

Study Record Updates

• Last Update Posted (Estimate): March 20, 2014
• Last Update Submitted That Met QC Criteria: March 19, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: hemodialysis; intradialytic exercise
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: E-25253