NCT01273753

Brief Summary

The purpose of this study is to examine the impact of exercise during dialysis using objective measures of fluid status determination, specifically bioimpedance analysis (BIA) and blood volume monitoring (BVM). We hypothesize that exercise during dialysis will be associated with more stable blood pressures and that this will be reflected in different output from BIA and BVM monitoring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

1.6 years

First QC Date

January 6, 2011

Last Update Submit

December 1, 2014

Conditions

Kidney Failure, Chronic

Keywords

End-stage renal diseaseHemodialysisBioimpedance analysisBlood volume monitoring

Outcome Measures

Primary Outcomes (1)

  • Change in bioimpedance analysis trend during dialysis

    The investigators will assess the impact of intradialytic exercise on body composition and fluid removal by comparing BIA measurements and trends between dialysis treatments. The baseline measurement will occur during standard usual dialysis, while the 4 week meaurement will occur during dialysis with exercise.

    Baseline (no exercise) and 4 weeks (with exercise)

Secondary Outcomes (1)

  • Blood volume monitoring

    Baseline (no exercise) and 4 weeks (with exercise)

Study Arms (1)

Exercise

ACTIVE COMPARATOR

After baseline measurements, all subjects will undergo a phase involving intradialytic exercise. Subjects will serve as their own controls.

Other: Intradialytic exercise

Interventions

Intradialytic exerciseOTHER

Patients will exercise using a stationary foot pedal cycle for 20 minutes at the beginning of hemodialysis.

Exercise

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18yrs and older
  • End-stage renal disease on thrice weekly maintenance hemodialysis for at least 3 months
  • Stable dry weight for the preceding month
  • Stable dialysis prescription for the preceding month
  • Average interdialytic weight gain at least 1kg but less than 4% of total body weight.

You may not qualify if:

  • Patients receiving dialysis for acute renal failure
  • Hospitalization \>1 day in the preceding month
  • Inability to complete exercise regimen or medical contraindication to exercise regimen
  • Patients in whom a dry weight is yet to be established
  • History of non-compliance with dialysis therapy (defined as \> 3 missed treatments in a month)
  • Inability to remain in horizontal position for duration of a dialysis session.
  • Amputation of a limb other than fingers or toes.
  • Pace maker, defibrillator, implantable pump, artificial joint, pins, plates or other types of metal objects in the body (other than dental fillings).
  • Coronary stents or metal suture material in the heart.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48103, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

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

Study Officials

  • Michael Heung, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 6, 2011

First Posted

January 10, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

US(1)