NCT02753868

Brief Summary

The purpose of this study is to examine the effect of cycling at mild to moderate intensity during hemodialysis treatment on cardiovascular function in a crossover design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

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

February 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

February 27, 2016

Last Update Submit

March 5, 2017

Conditions

Kidney Failure

Keywords

Intradialytic exerciseCardiac and arterial function

Outcome Measures

Primary Outcomes (2)

  • Serial change in brachial blood pressure (mmHg) from start to end of a dialysis treatment

    Systolic and diastolic blood pressure will be measured using an automated blood pressure cuff attached to the clinic dialysis machine

    Every 15 minutes throughout each dialysis treatment (approximately 4 hours)

  • Changes in cardiac output (mL/min) measured by thoracic impedance technique

    Cardiac output will be estimated continuously using thoracic impedance with electrodes placed around the chest.

    Continous throughout a dialysis treatment (approximately 4 hours)

Secondary Outcomes (2)

  • Changes in total peripheral resistance estimated by peripheral blood pressure via a finger plethysmography and cardiac output via thoracic impedance (Task Force Monitor)

    Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a week

  • Hypotensive event assessment measured by a symptom questionnaire

    Throughout and up to 5 hours after completion of a dialysis treatment

Study Arms (3)

Standard Hemodialysis

EXPERIMENTAL

Participants will be monitored during their normal hemodialysis treatment with no intervention administered

Procedure: Hemodialysis treatment

Hemodialysis with Exercise (1-st hr)

EXPERIMENTAL

Participants will be monitored during a normal dialysis treatment in which they cycle at mild to moderate intensity for 30 minutes during 1-st hour into treatment

Behavioral: exerciseProcedure: Hemodialysis treatment

Hemodialysis with Exercise (3-rd hr)

EXPERIMENTAL

Participants will be monitored during a normal dialysis treatment in which they cycle at mild to moderate intensity for 30 minutes during 3-rd hour into treatment

Behavioral: exerciseProcedure: Hemodialysis treatment

Interventions

exerciseBEHAVIORAL

Participants will be asked to cycle at mild to moderate intensity for 30 minutes during either 1-st hour of 3-rd hour into treatment

Hemodialysis with Exercise (1-st hr)Hemodialysis with Exercise (3-rd hr)
Hemodialysis treatmentPROCEDURE

Participants will receive a standard hemodialysis treatment during the study period

Hemodialysis with Exercise (1-st hr)Hemodialysis with Exercise (3-rd hr)Standard Hemodialysis

Eligibility Criteria

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

You may qualify if:

  • Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists

You may not qualify if:

  • Patients with established contraindications to exercise including lower-limb amputation, advanced chronic obstructive pulmonary disease and decompensated chronic heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

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

Renal Insufficiency

Interventions

Exercise

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kenneth Wilund, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 27, 2016

First Posted

April 28, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

March 7, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)