Trial of Hemodialysis Based Exercise for Strength Improvement Study

NCT ID: NCT01962597

Last Updated: 2016-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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aerobic exercise

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

Group Type ACTIVE_COMPARATOR

aerobic exercise

Intervention Type OTHER

resistance training

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

Group Type ACTIVE_COMPARATOR

resistance training

Intervention Type OTHER

aerobic exercise and resistance training

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

Group Type EXPERIMENTAL

aerobic exercise

Intervention Type OTHER

resistance training

Intervention Type OTHER

Interventions

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aerobic exercise

Intervention Type OTHER

resistance training

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Scott Brimble

Staff Nephrologist/Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Josephs Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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13-468

Identifier Type: -

Identifier Source: org_study_id

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