NCT01481688

Brief Summary

The purpose of this study is to investigate whether intradialytic exercise increases removal of waste products from blood, in comparison to the traditional prescription of increasing dialysis duration.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

November 29, 2011

Status Verified

November 1, 2011

Enrollment Period

2 months

First QC Date

November 24, 2011

Last Update Submit

November 28, 2011

Conditions

Chronic Kidney Disease

Keywords

Dialysis adequacyUrea clearancePhosphate clearanceBeta 2 microglobulin clearanceIntradialytic exerciseHaemodialysis patients

Outcome Measures

Primary Outcomes (1)

  • Urea clearance

    The primary outcome is urea clearance which will be measured by continuously sampling waste dialysate from an entire dialysis session.

    One dialysis session

Secondary Outcomes (1)

  • Urea clearance

    One dialysis session

Study Arms (3)

Control

NO INTERVENTION

Routine haemodialysis sessions as per usual

Intradialytic exercise

EXPERIMENTAL

One hour of exercise completed during haemodialysis.

Other: Exercise

Extra time

ACTIVE COMPARATOR

30 minutes extra dialysis time.

Other: Extra time

Interventions

ExerciseOTHER

Exercise During Dialysis Patients will be asked to carry out cycling exercise for 60 minutes during the third quarter of their routine haemodialysis session. Exercise can be carried out in ten minute bouts with several minutes rest between bouts.

Intradialytic exercise
Extra timeOTHER

An extra 30 minutes will be added to the currently prescribed treatment time of each patient.

Extra time

Eligibility Criteria

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

You may qualify if:

  • Stage 5 Chronic Kidney Disease
  • Receiving maintenance haemodialysis for \> 3 months

You may not qualify if:

  • Unable to give consent
  • Present with contraindications to take part in exercise
  • Haemoglobin \<11 g/dL
  • Access recirculation
  • Chronic persistent hypotension with pre dialysis systolic blood pressures \<100mgHg.
  • Episodic treatment induced hypotension with frequent drops in intradialytic systolic blood pressure \>30mmgHg
  • Unstable medical condition
  • Currently taking medication affecting urea or creatinine generation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renal unit, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board

Bangor, Gwynedd, LL57 2PW, United Kingdom

RECRUITING

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

Renal Insufficiency, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal 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

  • Jamie H Macdonald, PhD

    Bangor University

    STUDY DIRECTOR

Central Study Contacts

Jamie H Macdonald, PhD

CONTACT

0044 1248 383272j.h.macdonald@bangor.ac.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2011

First Posted

November 29, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 29, 2011

Record last verified: 2011-11

Locations

GB(1)