NCT02874521

Brief Summary

The purpose of the trial is to compare the effects of intra-dialytic low-frequency electrical muscle stimulation and intra-dialytic cycling, with usual care haemodialysis without exercise training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
Last Updated

August 22, 2016

Status Verified

August 1, 2016

Enrollment Period

1.5 years

First QC Date

August 17, 2016

Last Update Submit

August 17, 2016

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

  • Peak oxygen uptake (VO2peak)

    Cardiopulmonary exercise test

    Baseline, 10 weeks

Secondary Outcomes (4)

  • Muscular strength

    Baseline, 10 weeks

  • Arterial remodelling

    Baseline, 10 weeks

  • Cardiac remodelling

    Baseline, 10 weeks

  • Health related quality of life

    Baseline, 10 weeks

Study Arms (3)

Intra-dialytic LF-EMS

EXPERIMENTAL

Performed twice weekly whilst seated on a standard dialysis chair. Delivered by adhesive electrodes in a neoprene garment, applied bilaterally to the quadriceps and hamstrings. Cardiovascular stimulus via rapid, rhythmical, sub-tetanic contractions. Short bursts of four pulses repeatedly delivered by stimulator at a frequency of 4Hz. Current amplitude adjustable from 40 - 200 mA with inbuilt controller. Conducted for one hour at the maximum tolerable intensity. Five minute warm-up and cool down at a lower frequency (3 Hz).

Other: Intra-dialytic LF-EMS

Intra-dialytic cycle training

EXPERIMENTAL

Semi-recumbent cycling performed twice weekly whilst seated on a standard dialysis chair. Performed for up to one hour per session, initially at a workload (Watts) equivalent to that achieved at 40-60% VO2 reserve during cardiopulmonary exercise test. Exercise intensity regulated using a combination of heart rate and rating of perceived exertion (12-14). Workload adjusted weekly and controlled with a combination of pedal resistance and cadence to provide a personalised exercise prescription. Five minute warm-up and cool down each session.

Other: Intra-dialytic cycle training

Usual care

NO INTERVENTION

Continuation of dialysis treatment without the addition of an intra-dialytic exercise intervention.

Interventions

Intra-dialytic LF-EMSOTHER

Electrical muscle stimulation during haemodialysis

Also known as: Electrical muscle stimulation
Intra-dialytic LF-EMS
Intra-dialytic cycle trainingOTHER

Cycle training during haemodialysis

Intra-dialytic cycle training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • On haemodialysis for at least 3months
  • On 3 times 4 hours of dialysis per week
  • Urea reduction rate of at least 65% during the three months before enrolment
  • Age 18 years or older
  • Able to complete the exercise test and exercise training
  • Able to provide informed consent
  • Life expectancy of more than 6 months according to clinical assessment

You may not qualify if:

  • Clinically significant valvular insufficiency
  • Clinically significant dysrythmia
  • Uncontrolled blood pressure: systolic \> 160, diastolic \>95 during the months before enrolment
  • Excessive fluid accumulation between dialysis sessions (\>3 liters), more than twice pulmonary edema over 3 months before enrolment deemed to be due to excess fluid intake
  • Haemoglobin unstable and below 9.0
  • Ischemic cardiac event or intervention in the last 3 months
  • Clinically significant, still active inflammatory or malignant process
  • Pacemaker or cardiac device (contraindicated for bioelectrical impedance)
  • Planned kidney transplant during study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Coventry, CV2 2DX, United Kingdom

Location

Related Publications (7)

  • 2021 exceptional surveillance of chronic kidney disease (NICE guideline NG203) [Internet]. London: National Institute for Health and Care Excellence (NICE); 2021 Aug 25. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK576880/

    PMID: 35077091BACKGROUND

  • Heiwe S, Jacobson SH. Exercise training for adults with chronic kidney disease. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD003236. doi: 10.1002/14651858.CD003236.pub2.

    PMID: 21975737BACKGROUND

  • Bowen TS, Schuler G, Adams V. Skeletal muscle wasting in cachexia and sarcopenia: molecular pathophysiology and impact of exercise training. J Cachexia Sarcopenia Muscle. 2015 Sep;6(3):197-207. doi: 10.1002/jcsm.12043. Epub 2015 Jun 3.

    PMID: 26401465BACKGROUND

  • Koufaki P, Mercer TH, Naish PF. Effects of exercise training on aerobic and functional capacity of end-stage renal disease patients. Clin Physiol Funct Imaging. 2002 Mar;22(2):115-24. doi: 10.1046/j.1365-2281.2002.00405.x.

    PMID: 12005153BACKGROUND

  • Cheema B, Abas H, Smith B, O'Sullivan A, Chan M, Patwardhan A, Kelly J, Gillin A, Pang G, Lloyd B, Fiatarone Singh M. Randomized controlled trial of intradialytic resistance training to target muscle wasting in ESRD: the Progressive Exercise for Anabolism in Kidney Disease (PEAK) study. Am J Kidney Dis. 2007 Oct;50(4):574-84. doi: 10.1053/j.ajkd.2007.07.005.

    PMID: 17900457BACKGROUND

  • Smart NA, Dieberg G, Giallauria F. Functional electrical stimulation for chronic heart failure: a meta-analysis. Int J Cardiol. 2013 Jul 15;167(1):80-6. doi: 10.1016/j.ijcard.2011.12.019. Epub 2012 Jan 10.

    PMID: 22236510BACKGROUND

  • 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, 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

  • Godon S McGregor, PhD

    UHCW NHS Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 22, 2016

Study Start

March 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

August 22, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)