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

End Stage Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877863
• Other study ID #: E-25253
• Status: Completed
• Phase: N/A
• First received: May 27, 2013
• Last updated: March 19, 2014
• Start date: May 2013

Study information

• Verified date: March 2014
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Other:
• exercise
12 weeks of intradialytic biking at Borg intensity 3 - 4 for 15 to 60 minutes on each dialysis run

Locations

Country	Name	City	State
Canada	Northwest Dialysis Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Aerobic capacity	Aerobic capacity is measured as a function of the DASI score	12 weeks	No
Secondary	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	No
Secondary	Quality of life	The KDQOL- SF36 will be used to measure the quality of life at baseline and again at 12 weeks.	12 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Hemoglobin levels	The baseline hemoglobin and hemoglobin at 12 weeks will be tracked.	12 weeks	No
Secondary	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	No
Secondary	Urea removal	The baseline and 12 week pre and post dialysis urea levels will be monitored.	12 weeks	No
Secondary	Phosphate levels	The baseline and 12 week pre-dialysis phosphate levels will be tracked.	12 weeks	No
Secondary	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	No