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

April 18, 2016 updated by: Scott Brimble, St. Joseph's Healthcare Hamilton

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 10 and 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
Time Frame: 10 and 20 weeks
repeated measures analysis
10 and 20 weeks
change in EuroQOL-5D-5L over 20 weeks
Time Frame: 10 and 20 weeks
Health-related quality of life. Repeated measures analysis
10 and 20 weeks
change in dialysis recovery time over 20 weeks
Time Frame: 10 and 20 weeks
repeated measures analysis
10 and 20 weeks
change in Nottingham extended activities of daily living index over 20 weeks
Time Frame: 10 and 20 weeks
repeated measures analysis
10 and 20 weeks
change in body anthropometry and composition over 20 weeks.
Time Frame: 10 and 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
Time Frame: 10 and 20 weeks
serum albumin, C-reactive protein, interleukin-6 and tumor necrosis factor-alpha. Repeated measures analysis
10 and 20 weeks
hospitalization
Time Frame: continuous over 20 weeks
continuous over 20 weeks
death
Time Frame: continuous over 20 weeks
continuous over 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-468

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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