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

Primary Purpose

End Stage Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
aerobic exercise
resistance training
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring hemodialysis, aerobic exercise, resistance training, walking speed, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Josephs Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

aerobic exercise

resistance training

aerobic exercise and resistance training

Arm Description

patients will undergo supervised exercise on a bike ergometer for 30 minutes three times per week during hemodialysis

patients will undergo supervised lower extremity strength training three times per week pre-hemodialysis

patients will undergo a combination of aerobic exercise and resistance training on an alternating schedule three time per week

Outcomes

Primary Outcome Measures

change in walking speed over 20 weeks
repeated measures analysis

Secondary Outcome Measures

change in short physical performance battery over 20 weeks
repeated measures analysis
change in EuroQOL-5D-5L over 20 weeks
Health-related quality of life. Repeated measures analysis
change in dialysis recovery time over 20 weeks
repeated measures analysis
change in Nottingham extended activities of daily living index over 20 weeks
repeated measures analysis
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
change in inflammation measures over 20 weeks
serum albumin, C-reactive protein, interleukin-6 and tumor necrosis factor-alpha. Repeated measures analysis
hospitalization
death

Full Information

First Posted
October 8, 2013
Last Updated
April 18, 2016
Sponsor
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT01962597
Brief Title
Trial of Hemodialysis Based Exercise for Strength Improvement Study
Acronym
THESIS
Official Title
Comparison of Aerobic Exercise, Strength Training, or Its Combination in Hemodialysis Patients: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
hemodialysis, aerobic exercise, resistance training, walking speed, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aerobic exercise
Arm Type
Active Comparator
Arm Description
patients will undergo supervised exercise on a bike ergometer for 30 minutes three times per week during hemodialysis
Arm Title
resistance training
Arm Type
Active Comparator
Arm Description
patients will undergo supervised lower extremity strength training three times per week pre-hemodialysis
Arm Title
aerobic exercise and resistance training
Arm Type
Experimental
Arm Description
patients will undergo a combination of aerobic exercise and resistance training on an alternating schedule three time per week
Intervention Type
Other
Intervention Name(s)
aerobic exercise
Intervention Type
Other
Intervention Name(s)
resistance training
Primary Outcome Measure Information:
Title
change in walking speed over 20 weeks
Description
repeated measures analysis
Time Frame
10 and 20 weeks
Secondary Outcome Measure Information:
Title
change in short physical performance battery over 20 weeks
Description
repeated measures analysis
Time Frame
10 and 20 weeks
Title
change in EuroQOL-5D-5L over 20 weeks
Description
Health-related quality of life. Repeated measures analysis
Time Frame
10 and 20 weeks
Title
change in dialysis recovery time over 20 weeks
Description
repeated measures analysis
Time Frame
10 and 20 weeks
Title
change in Nottingham extended activities of daily living index over 20 weeks
Description
repeated measures analysis
Time Frame
10 and 20 weeks
Title
change in body anthropometry and composition over 20 weeks.
Description
weight, waist-hip ratio, bioimpedance analysis-determined fat-free mass, percentage body fat, phase angle. Repeated measures analysis
Time Frame
10 and 20 weeks
Title
change in inflammation measures over 20 weeks
Description
serum albumin, C-reactive protein, interleukin-6 and tumor necrosis factor-alpha. Repeated measures analysis
Time Frame
10 and 20 weeks
Title
hospitalization
Time Frame
continuous over 20 weeks
Title
death
Time Frame
continuous over 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
St. Josephs Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

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Trial of Hemodialysis Based Exercise for Strength Improvement Study

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