Clinical trial NCT01962597: Trial of Hemodialysis Based Exercise for Strength Improvement Study
Official title: Comparison of Aerobic Exercise, Strength Training, or Its Combination in Hemodialysis Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease
Keywords: hemodialysis
aerobic exercise
resistance training
walking speed
randomized controlled trial
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* Scheduled living related kidney transplant in next 6 months

Primary outcomes:
measure: change in walking speed over 20 weeks
timeFrame: 10 and 20 weeks
Secondary outcomes:
measure: change in short physical performance battery over 20 weeks
timeFrame: 10 and 20 weeks
measure: change in EuroQOL-5D-5L over 20 weeks
timeFrame: 10 and 20 weeks
measure: change in dialysis recovery time over 20 weeks
timeFrame: 10 and 20 weeks
measure: change in Nottingham extended activities of daily living index over 20 weeks
timeFrame: 10 and 20 weeks
measure: change in body anthropometry and composition over 20 weeks.
timeFrame: 10 and 20 weeks
measure: change in inflammation measures over 20 weeks
timeFrame: 10 and 20 weeks
measure: hospitalization
timeFrame: continuous over 20 weeks
measure: death
timeFrame: continuous over 20 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Josephs Healthcare Hamilton
state: Ontario
Study officials:
References: