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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04877041




Registration number
NCT04877041
Ethics application status
Date submitted
3/05/2021
Date registered
7/05/2021

Titles & IDs
Public title
Exercise and Cardiac Stunning During HD
Scientific title
Trial of Intradialytic Cycling as Kidney Exercise Rehabilitation for Cardiac Stunning in Hemodialysis (TICKERS-HD)
Secondary ID [1] 0 0
HS24857 (B2021:039)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-stage Kidney Disease 0 0
Hemodialysis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Intradialytic Cycling

Experimental: Exercise (Intradialytic Cycling) - Participants will receive a standardized baseline exercise counseling session as per control and then participate in a supervised intradialytic cycling program for 12-weeks

No intervention: Usual Care - Participants will receive a standardized baseline exercise counseling session. Participants in the control group will not undergo formal exercise intervention, but will not be prohibited from participating in exercise outside of hemodialysis. They will be asked to not to participate in intradialytic cycling during the study (16 weeks total).


BEHAVIORAL: Intradialytic Cycling
This intervention will consist of intradialytic cycling for 60 minutes 3 times per week for a total of 12 weeks.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 12 weeks measured using echocardiography
Timepoint [1] 0 0
Baseline to 12 weeks
Secondary outcome [1] 0 0
Change in post-hemodialysis high sensitivity Troponin T level from baseline to 12 weeks
Timepoint [1] 0 0
Baseline to 12 weeks
Secondary outcome [2] 0 0
Change in difference between pre-hemodialysis and post-hemodialysis Troponin T from baseline to 12 weeks
Timepoint [2] 0 0
Baseline to 12 weeks
Secondary outcome [3] 0 0
Change in severity of post-hemodialysis fatigue
Timepoint [3] 0 0
Baseline to 12 weeks
Secondary outcome [4] 0 0
Change in Symptom Burden
Timepoint [4] 0 0
Baseline to 12 weeks
Secondary outcome [5] 0 0
Change in Exercise Capacity
Timepoint [5] 0 0
Baseline to 12 weeks
Secondary outcome [6] 0 0
Change in Physical Activity Behaviour Patterns
Timepoint [6] 0 0
Baseline to 12 weeks
Secondary outcome [7] 0 0
Change in number of regional wall motion abnormalities at peak HD stress
Timepoint [7] 0 0
Baseline to 1 week
Secondary outcome [8] 0 0
Change in number of regional wall motion abnormalities at peak HD stress
Timepoint [8] 0 0
Baseline to 16 weeks
Secondary outcome [9] 0 0
Feasiblity - Recruitment
Timepoint [9] 0 0
Baseline to 12 weeks
Secondary outcome [10] 0 0
Feasibility - Eligibility
Timepoint [10] 0 0
Baseline to 12 weeks
Secondary outcome [11] 0 0
Feasibility - Adherence
Timepoint [11] 0 0
Baseline to 16 weeks
Secondary outcome [12] 0 0
Feasibility - Exercise Adherence: Proportion of exercise sessions completed
Timepoint [12] 0 0
Baseline to 12 weeks
Secondary outcome [13] 0 0
Feasibility - Exercise Adherence: Total minutes of exercise
Timepoint [13] 0 0
Baseline to 12 weeks
Secondary outcome [14] 0 0
Change in Cognitive Function
Timepoint [14] 0 0
Baseline to 12 weeks

Eligibility
Key inclusion criteria
* Adults > or equal to 18 years old (no upper age limit); who are > 3 months after starting maintenance hemodialysis
* No expected change in dialysis modality, elective surgery or relocation outside of study site during the intervention period (16 weeks)
* Assessed to be safe and able to exercise by the hemodialysis unit nephrologist
* Able to communicate in English and provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Acute coronary syndrome in the past 3 months
* Unstable arrhythmia
* Shortness of breath at rest or with minimal activity (NYHA Class 4)
* Symptomatic hypoglycemia (>2x/week in week prior to enrolment)
* Participating in clinical intradialytic cycling program in last 3 months (if a clinical program exists)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of South Australia - Adelaide
Recruitment postcode(s) [1] 0 0
5001 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Manitoba
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
University of Manitoba
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clara Bohm, MD, MPH
Address 0 0
University of Manitoba
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clara Bohm, MD, MPH
Address 0 0
Country 0 0
Phone 0 0
204-631-3834
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04877041