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Exercise During Dialysis for Hemodialysis Patients
N/A
Recruiting
Led By Clara Bohm, MD, MPH
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 16 weeks
Awards & highlights
Study Summary
This trial will test if cycling during dialysis can reduce heart damage from dialysis in adults.
Who is the study for?
This trial is for adults over 18 who've been on hemodialysis for at least 3 months, with no major changes in their treatment expected. They must be cleared to exercise by a kidney doctor and able to communicate in English. People with recent heart issues, unstable heart rhythms, severe breathlessness, frequent low blood sugar episodes or those already doing similar cycling exercises can't join.Check my eligibility
What is being tested?
The study tests if cycling during dialysis sessions over 12 weeks affects the temporary weakening of the heart muscle that sometimes happens after hemodialysis (myocardial stunning). Participants will cycle while undergoing their regular dialysis treatments.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include muscle soreness, fatigue from exercise during dialysis sessions or exacerbation of existing health conditions due to physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 12 weeks measured using echocardiography
Secondary outcome measures
Change in Cognitive Function
Change in Exercise Capacity
Change in Physical Activity Behaviour Patterns
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise (Intradialytic Cycling)Experimental Treatment1 Intervention
Participants will receive a standardized baseline exercise counseling session as per control and then participate in a supervised intradialytic cycling program for 12-weeks
Group II: Usual CareActive Control1 Intervention
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).
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Who is running the clinical trial?
University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,366 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,257 Total Patients Enrolled
Clara Bohm, MD, MPHPrincipal InvestigatorUniversity of Manitoba
2 Previous Clinical Trials
132 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't plan any major changes like surgery or moving for the next 16 weeks.I am 18 or older and have been on maintenance hemodialysis for over 3 months.I have had low blood sugar symptoms more than twice a week recently.I had a heart attack or other heart issue in the last 3 months.I do not have an irregular heartbeat that changes often.I experience severe shortness of breath even when resting.You have been in a special exercise program during dialysis in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise (Intradialytic Cycling)
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are involved in this investigation?
"Affirmative. Clinicaltrials.gov records show that this medical research is presently looking for participants, with a first posting date of March 1st 2023 and most recent update on the 22nd of said month. In total, 160 individuals need to be recruited from 4 centres."
Answered by AI
Are there still available slots in this research project?
"Affirmative. Clinicaltrials' records demonstrate that this clinical trial is presently searching for participants, having been initially posted on March 1st 2023 and updated most recently on the 22nd of March 2023. This study requires 160 individuals to be enrolled across 4 medical sites."
Answered by AI
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