NCT01877863

Brief Summary

The purpose of this study is to explore the impact of an intradialytic exercise program on functional capacity, aerobic capacity, strength, quality of life, depression, hospitalizations and intradialytic episodes of hypotension. The investigators would also like to look at the impact of exercise training over twelve weeks on hemoglobin levels as well as the clearance of potassium, phosphate and urea. Our hypothesis is that the above mentioned outcomes will positively improve over the twelve week intervention.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 14, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

March 20, 2014

Status Verified

March 1, 2014

Enrollment Period

7 months

First QC Date

May 27, 2013

Last Update Submit

March 19, 2014

Conditions

Keywords

intradialytic exercisehemodialysis

Outcome Measures

Primary Outcomes (1)

  • Functional Capacity

    Functional capacity is measured by the DASI score which gives an estimated V02 peak in ml/min/kg. The difference between the mean score at baseline and 12 weeks will be determined.

    12 weeks

Secondary Outcomes (10)

  • Aerobic capacity

    12 weeks

  • Strength

    12 weeks

  • Quality of life

    12 weeks

  • Hospitalizations

    12 weeks

  • Hypotension

    12 weeks

  • +5 more secondary outcomes

Study Arms (1)

intradialytic exercise

EXPERIMENTAL

baseline data prior to starting exercise program will be obtained and then compared to the data after 12 weeks of an intradialtyic biking program

Other: exercise

Interventions

12 weeks of intradialytic biking at Borg intensity 3 - 4 for 15 to 60 minutes on each dialysis run

Also known as: intradialytic exercise, intradialytic biking, biking on hemodialysis
intradialytic exercise

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiac and hemodynamic stability
  • Absence of severe musculoskeletal impairment
  • Increased musculoskeletal weakness
  • Vital signs within normal range for exercise
  • Desire/motivated to exercise
  • Clearance from nephrologist and Kinesiologist

You may not qualify if:

  • Compromised cardiac profiles
  • Hemodynamic instability
  • Severe bone disease
  • Medical conditions which contraindicate exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwest Dialysis Centre

Calgary, Alberta, T2L 2J8, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jennifer MacRae

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2013

First Posted

June 14, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2013

Last Updated

March 20, 2014

Record last verified: 2014-03

Locations