Trial of Hemodialysis Based Exercise for Strength Improvement Study

N/AUnknownNCT01962597

St. Joseph's Healthcare Hamilton60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

End Stage Renal Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

change in walking speed over 20 weeks

repeated measures analysis

Time frame: 10 and 20 weeks

Secondary Outcomes

change in short physical performance battery over 20 weeks

repeated measures analysis

Time frame: 10 and 20 weeks

change in EuroQOL-5D-5L over 20 weeks

Health-related quality of life. Repeated measures analysis

Time frame: 10 and 20 weeks

change in dialysis recovery time over 20 weeks

repeated measures analysis

Time frame: 10 and 20 weeks

change in Nottingham extended activities of daily living index over 20 weeks

repeated measures analysis

Time frame: 10 and 20 weeks

change in body anthropometry and composition over 20 weeks.

weight, waist-hip ratio, bioimpedance analysis-determined fat-free mass, percentage body fat, phase angle. Repeated measures analysis

Time frame: 10 and 20 weeks

change in inflammation measures over 20 weeks

serum albumin, C-reactive protein, interleukin-6 and tumor necrosis factor-alpha. Repeated measures analysis

Time frame: 10 and 20 weeks

hospitalization

Time frame: continuous over 20 weeks

death

Time frame: continuous over 20 weeks

Trial of Hemodialysis Based Exercise for Strength Improvement Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes