Trial of Hemodialysis Based Exercise for Strength Improvement Study (THESIS)

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

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 Overview

• Status: Unknown
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Other: aerobic exercise; Other: resistance training

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Josephs Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: aerobic exercise; patients will undergo supervised exercise on a bike ergometer for 30 minutes three times per week during hemodialysis	Other: aerobic exercise
Active Comparator: resistance training; patients will undergo supervised lower extremity strength training three times per week pre-hemodialysis	Other: resistance training
Experimental: aerobic exercise and resistance training; patients will undergo a combination of aerobic exercise and resistance training on an alternating schedule three time per week	Other: aerobic exercise; Other: resistance training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in walking speed over 20 weeks	repeated measures analysis	10 and 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in short physical performance battery over 20 weeks	repeated measures analysis	10 and 20 weeks
change in EuroQOL-5D-5L over 20 weeks	Health-related quality of life. Repeated measures analysis	10 and 20 weeks
change in dialysis recovery time over 20 weeks	repeated measures analysis	10 and 20 weeks
change in Nottingham extended activities of daily living index over 20 weeks	repeated measures analysis	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	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	10 and 20 weeks
hospitalization		continuous over 20 weeks
death		continuous over 20 weeks

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 14, 2013

Study Record Updates

• Last Update Posted (Estimate): April 19, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: randomized controlled trial; aerobic exercise; hemodialysis; resistance training; walking speed
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 13-468