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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
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Scientific title
Trial of Intradialytic Cycling as Kidney Exercise Rehabilitation for Cardiac Stunning in Hemodialysis (TICKERS-HD)
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Secondary ID [1]
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HS24857 (B2021:039)
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
End-stage Kidney Disease
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Hemodialysis
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 12 weeks measured using echocardiography
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Assessment method [1]
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Using standard left ventricular apical 2-, 3-, and 4-chamber views and left ventricular parasternal short-axis views collected by the same trained operator at each site 3 times during the mid-week hemodialysis session at each assessment time point as follows: baseline (pre hemodialysis), post-cycling exercise (or mid-dialysis in controls) and at peak hemodialysis stress (\~30 min prior to end of hemodialysis). Echocardiogram image analysis will be performed in London, ON using automated speckle-tracking analysis (EchoPAC-PC software version 110.1.3; GE Healthcare).
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Timepoint [1]
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Baseline to 12 weeks
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Secondary outcome [1]
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Change in post-hemodialysis high sensitivity Troponin T level from baseline to 12 weeks
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Assessment method [1]
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Measured by Roche High-Sensitivity Troponin T assay at each site.
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Timepoint [1]
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Baseline to 12 weeks
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Secondary outcome [2]
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Change in difference between pre-hemodialysis and post-hemodialysis Troponin T from baseline to 12 weeks
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Assessment method [2]
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Measured by Roche High-Sensitivity Troponin T assay at each site.
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Timepoint [2]
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Baseline to 12 weeks
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Secondary outcome [3]
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Change in severity of post-hemodialysis fatigue
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Assessment method [3]
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Assessed by the self-reported answer (in minutes) to the question: "How long does it take you to recover from a dialysis session and resume your normal, usual activities?"
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Timepoint [3]
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Baseline to 12 weeks
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Secondary outcome [4]
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Change in Symptom Burden
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Assessment method [4]
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Measured using the Dialysis Symptom Index (DSI) Severity Score. Score 0 to 150 with 0 no symptoms and 150 most number and severity of symptoms
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Timepoint [4]
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Baseline to 12 weeks
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Secondary outcome [5]
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Change in Exercise Capacity
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Assessment method [5]
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Measured by the Incremental Shuttle Walk Test (ISWT)
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Timepoint [5]
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Baseline to 12 weeks
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Secondary outcome [6]
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Change in Physical Activity Behaviour Patterns
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Assessment method [6]
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Assessed using total active minutes per day as measure by multi-directional accelerometry
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Timepoint [6]
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Baseline to 12 weeks
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Secondary outcome [7]
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Change in number of regional wall motion abnormalities at peak HD stress
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Assessment method [7]
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Measured at each study time point to further assess how exercise training effects HD-related cardiac stunning over time
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Timepoint [7]
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Baseline to 1 week
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Secondary outcome [8]
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Change in number of regional wall motion abnormalities at peak HD stress
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Assessment method [8]
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Measured at each study time point to further assess how exercise training effects HD-related cardiac stunning over time
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Timepoint [8]
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Baseline to 16 weeks
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Secondary outcome [9]
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Feasiblity - Recruitment
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Assessment method [9]
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Proportion of individuals eligible for study that were recruited
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Timepoint [9]
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Baseline to 12 weeks
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Secondary outcome [10]
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Feasibility - Eligibility
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Assessment method [10]
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Proportion of individuals approached eligible for enrolment into study
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Timepoint [10]
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Baseline to 12 weeks
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Secondary outcome [11]
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Feasibility - Adherence
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Assessment method [11]
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Proportion of participants that completed the study
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Timepoint [11]
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Baseline to 16 weeks
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Secondary outcome [12]
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Feasibility - Exercise Adherence: Proportion of exercise sessions completed
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Assessment method [12]
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Proportion of total exercise sessions during study completed
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Timepoint [12]
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Baseline to 12 weeks
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Secondary outcome [13]
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Feasibility - Exercise Adherence: Total minutes of exercise
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Assessment method [13]
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Proportion of total possible minutes of intradialytic cycling completed during the study
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Timepoint [13]
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Baseline to 12 weeks
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Secondary outcome [14]
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Change in Cognitive Function
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Assessment method [14]
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Change in cognitive function score measured by Cambridge Brain Science testing
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Timepoint [14]
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Baseline to 12 weeks
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2025
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Actual
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Sample size
Target
160
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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University of South Australia - Adelaide
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Recruitment postcode(s) [1]
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5001 - Adelaide
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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Manitoba
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Country [3]
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Canada
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State/province [3]
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Ontario
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Manitoba
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine the effect of a 12-week cycling during hemodialysis program on hemodialysis-induced myocardial stunning in adult individuals receiving hemodialysis.
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Trial website
https://clinicaltrials.gov/study/NCT04877041
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clara Bohm, MD, MPH
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Address
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University of Manitoba
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Clara Bohm, MD, MPH
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Address
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Country
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Phone
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204-631-3834
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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