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Clinical Trials/NCT01962597
NCT01962597
Unknown
Not Applicable

Comparison of Aerobic Exercise, Strength Training, or Its Combination in Hemodialysis Patients: a Randomized Controlled Trial

St. Joseph's Healthcare Hamilton1 site in 1 country60 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End Stage Renal Disease
Sponsor
St. Joseph's Healthcare Hamilton
Enrollment
60
Locations
1
Primary Endpoint
change in walking speed over 20 weeks
Last Updated
10 years ago

Overview

Brief Summary

Study Hypothesis: The combination of aerobic and resistance exercise training will improve walking speed compared to either individual intervention.

Brief Summary:

Sixty hemodialysis participants who meet inclusion and exclusion criteria will be randomized to 20 weeks of supervised exercise, using either: (i) on-dialysis aerobic exercise using a bike ergometer; (ii) pre-dialysis leg strength training using weights; or (iii) both. The primary outcome is walking speed over 4-metres. Secondary outcomes will include:

(i) short physical performance battery; (ii) health-related quality of life [EuroQOL-5D-5L]; (iii) Dialysis recovery time; (iv) Nottingham extended activities of daily living (EADL) index; (v) Leg strength; (vi) body composition and anthropometry.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
September 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Scott Brimble

Staff Nephrologist/Associate Professor of Medicine

St. Joseph's Healthcare Hamilton

Eligibility Criteria

Inclusion Criteria

  • At least 18 years of age
  • On hemodialysis minimum of 3 times per week
  • On hemodialysis \> 3 consecutive months

Exclusion Criteria

  • Inability to provide consent
  • Inability to walk 4-metres
  • Chest pain with exertion or myocardial infarction in past 6-months
  • Pre-dialysis systolic blood pressure \> 200 mm Hg or diastolic BP \> 100 mm Hg in past 2-weeks
  • Functional or cardiorespiratory limitations preventing use of cycle ergometer for at least five-minutes or the ability to perform single maximum rep with each of resistance exercises described
  • Joint replacement or lower extremity fracture in previous 6-months
  • Severe cognitive impairment
  • Currently using corticosteroids \>5 mg/day
  • Pre-dialysis serum potassium in previous month less than 3.5 or greater than 6.0 mmol/L.
  • Attending nephrologist feels exercise is medically contraindicated

Outcomes

Primary Outcomes

change in walking speed over 20 weeks

Time Frame: 10 and 20 weeks

repeated measures analysis

Secondary Outcomes

  • change in short physical performance battery over 20 weeks(10 and 20 weeks)
  • change in body anthropometry and composition over 20 weeks.(10 and 20 weeks)
  • change in EuroQOL-5D-5L over 20 weeks(10 and 20 weeks)
  • change in Nottingham extended activities of daily living index over 20 weeks(10 and 20 weeks)
  • change in dialysis recovery time over 20 weeks(10 and 20 weeks)
  • death(continuous over 20 weeks)
  • change in inflammation measures over 20 weeks(10 and 20 weeks)
  • hospitalization(continuous over 20 weeks)

Study Sites (1)

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