- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07507981
Effects of Exercise in Hemodialysis
Effects of an Intradialytic Aerobic Exercise Program on Echocardiographic Findings in Patients With End-Stage Chronic Kidney Disease on Hemodialysis
Objective: To evaluate the effects of a six-month intradialytic aerobic exercise program on left ventricular ejection fraction in patients with end-stage kidney disease undergoing maintenance hemodialysis.
Materials and Methods Design: Open-label, single-center, quasi-experimental, single-group study with pre- and post-intervention measurements.
Study setting: the outpatient hemodialysis unit of the National Institute of Medical Sciences and Nutrition Salvador Zubirán.
Participants: Patients aged ≥18 years with chronic kidney disease on hemodialysis for at least three months, who are at their dry weight.
Procedures: An echocardiogram will be performed post-hemodialysis. Subsequently, patients will undergo a 30-minute intradialytic aerobic exercise program at submaximal intensity during the second hour of dialysis, three times per week for six months. At the end of the six-month period, a post-hemodialysis echocardiogram will be repeated.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mexico City, Mexico, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged ≥18 years
- Receiving hemodialysis with a stable prescription for at least 3 months
- At their prescribed dry weight
- Provision of written informed consent
Exclusion Criteria:
- Active cardiovascular disease within the past 3 months
- Left ventricular ejection fraction <40%
- Physical and/or cognitive impairment precluding exercise
- Blood pressure >160/110 mmHg
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients on hemodialysis who will perform intradialytic aerobic exercise
Patients on hemodialysis who will perform intradialytic aerobic exercise for six months
|
A six-month intradialytic aerobic exercise program consisting of 30-minute sessions at submaximal intensity, performed during the second hour of hemodialysis three times per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Left ventricular ejection fraction
Time Frame: From study enrollment to the initiation of the exercise program (within a maximum of 6 weeks), and subsequently from completion of the exercise program to up to 6 weeks thereafter
|
Left ventricular ejection fraction measured by transthoracic echocardiogram
|
From study enrollment to the initiation of the exercise program (within a maximum of 6 weeks), and subsequently from completion of the exercise program to up to 6 weeks thereafter
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NMM-5123-24-25-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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