NCT00492362

Brief Summary

Randomized controlled trial comparing effects of ergometer exercise during hemodialysis to effects of pedometer use outside of hemodialysis on exercise capacity, functional status, quality of life and adequacy of hemodialysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 4, 2008

Status Verified

June 1, 2008

Enrollment Period

10 months

First QC Date

June 26, 2007

Last Update Submit

June 2, 2008

Conditions

Kidney Failure, Chronic

Keywords

hemodialysisexercisephysical fitnessdialysis adequacy

Outcome Measures

Primary Outcomes (2)

  • Aerobic exercise capacity as measured by VO2 peak

    3 and 6 months

  • physical function as measured by sit to stand to sit; sit and reach and 6 minute walk test

    3 and 6 months

Secondary Outcomes (2)

  • quality of life measured by SF36

    3 and 6 months

  • dialysis adequacy as measured by ktV

    3 and 6 months

Study Arms (2)

A

ACTIVE COMPARATOR

Ergometer during hemodialysis

Behavioral: ergometer exercise during hemodialysis

B

ACTIVE COMPARATOR

Pedometer use outside of hemodialysis

Behavioral: pedometer activity outside of hemodialysis

Interventions

ergometer exercise during hemodialysisBEHAVIORAL
A
pedometer activity outside of hemodialysisBEHAVIORAL
B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult (\>18 years old) patients
  • Treated with hemodialysis for \> 3 months
  • Hemoglobin \> 100 g/L over the previous 2 months
  • Kt/V \> 1.2 for last month and no history of shortened dialysis due to hemodialysis access issues or frequent alarming during dialysis due to poor access will be eligible for the study.
  • Study patients must also be likely able to complete 12 consecutive weeks of exercise (i.e. no travel, change of modality, elective surgery planned) and must be able to comprehend instructions in English.

You may not qualify if:

  • Acute medical illness in last month
  • Unstable hemodialysis with frequent hypotension over the past month
  • Active cardiovascular disease (stroke or acute coronary syndrome, unstable angina) in last 3 months
  • Lower extremity amputation with no prosthesis (inability to pedal a bike)
  • Spine compression fractures
  • Severe musculoskeletal pain at rest or with minimal activity
  • Inability to sit, stand or walk unassisted (walking devices such as cane will be allowed)
  • Shortness of breath at rest or with activities of daily living (NYHA Class IV)
  • Labile glycemic control with hypoglycaemic episodes \> 1x/week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sherbrook Dialysis Unit

Winnipeg, Manitoba, R3A1M2, Canada

Location

Central Dialysis Unit, Health Sciences Centre

Winnipeg, Manitoba, R3A1R9, Canada

Location

Seven Oaks General Hospital

Winnipeg, Manitoba, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Location

Related Publications (1)

  • Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.

    PMID: 35018639DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicMotor Activity

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 SymptomsBehavior

Study Officials

  • Clara J Bohm, MD

    University of Manitoba; Manitoba Renal Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 27, 2007

Study Start

July 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 4, 2008

Record last verified: 2008-06

Locations

CA(4)