Trial of Hemodialysis Based Exercise for Strength Improvement Study

End Stage Renal Disease Clinical Trial

— THESIS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01962597
• Other study ID #: 13-468
• Status: Active, not recruiting
• Phase: N/A
• First received: October 8, 2013
• Last updated: April 18, 2016
• Start date: October 2013
• Est. completion date: September 2017

Study information

• Verified date: April 2016
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• aerobic exercise

• resistance training

Locations

Country	Name	City	State
Canada	St. Josephs Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in walking speed over 20 weeks	repeated measures analysis	10 and 20 weeks	No
Secondary	change in short physical performance battery over 20 weeks	repeated measures analysis	10 and 20 weeks	No
Secondary	change in EuroQOL-5D-5L over 20 weeks	Health-related quality of life. Repeated measures analysis	10 and 20 weeks	No
Secondary	change in dialysis recovery time over 20 weeks	repeated measures analysis	10 and 20 weeks	No
Secondary	change in Nottingham extended activities of daily living index over 20 weeks	repeated measures analysis	10 and 20 weeks	No
Secondary	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	10 and 20 weeks	No
Secondary	change in inflammation measures over 20 weeks	serum albumin, C-reactive protein, interleukin-6 and tumor necrosis factor-alpha. Repeated measures analysis	10 and 20 weeks	No
Secondary	hospitalization		continuous over 20 weeks	Yes
Secondary	death		continuous over 20 weeks	Yes