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Completed

NCT Number: NCT01877863

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.

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Key information

Conditions

End Stage Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwest Dialysis Centre

Calgary, Alberta, T2L 2J8, Canada

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Exercise

Other

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

Primary outcomes

  1. Functional Capacity

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Aerobic capacity

    Time frame: 12 weeks

    Aerobic capacity is measured as a function of the DASI score

  2. Strength

    Time frame: 12 weeks

    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.

  3. Quality of life

    Time frame: 12 weeks

    The KDQOL- SF36 will be used to measure the quality of life at baseline and again at 12 weeks.

  4. Hospitalizations

    Time frame: 12 weeks

    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.

  5. Hypotension

    Time frame: 12 weeks

    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.

  6. Hemoglobin levels

    Time frame: 12 weeks

    The baseline hemoglobin and hemoglobin at 12 weeks will be tracked.

  7. Potassium levels

    Time frame: 12 weeks

    The baseline potassium and potassium at 12 weeks as well as the K gradient (pre -dialysis - dialysate K level)will be monitored.

  8. Urea removal

    Time frame: 12 weeks

    The baseline and 12 week pre and post dialysis urea levels will be monitored.

  9. Phosphate levels

    Time frame: 12 weeks

    The baseline and 12 week pre-dialysis phosphate levels will be tracked.

  10. Bioimpedance derived volume and body mass determinations

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
First posted
Jun 14, 2013
Registry last updated
Mar 20, 2014

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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