- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06428773
Effect of Exercise on Vessel Diameter in Hemodialysis Patients
Study Overview
Detailed Description
Background: As it is known, many negative situations occur in CKD patients on hemodialysis. One of these is the problems seen in the vascular access. The prevention and management of vascular access complications may benefit from exercise The purpose of this study is to investigate the effect of exercise on the vessel diameter in HD patients.
Methods: Present study we were included 100 hemodialysis patients between the ages of 18-65.Participants were randomly divided into two groups: the exercise group and the control group. The exercise group performed moderate-intensity aerobic exercise on a stationary bicycle ergometer for 30 minutes during hemodialysis sessions, three days a week over 12 weeks. Additionally, the exercise group engaged in walking exercise for 30 minutes, three days a week outside of hemodialysis sessions, maintaining the heart rate between 50-60%. The exercise group also performed isolated exercises to expand wrist vessels, including wrist and elbow flexion, extension, and rotation, repeated 10 times, 2-3 days a week outside of hemodialysis sessions. And the vessel diameters of patients were measured by ultrasound at the beginning and after 12 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kırşehir, Turkey, 40100
- Kırşehir Ahi Evran University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between 18-65 years of age
- Undergoing hemodialysis treatment for at least 6 months
- Using arteriovenous fistula, arteriovenous graft, or permanent catheter as the vascular access type.
- Having no orthopedic, neurological, cardiac, or respiratory diseases that could hinder exercise
- Willingness to participate in exercise.
Exclusion Criteria:
- Access complications such as acute or chronic infections, inflammation, bleeding, aneurysms, stenosis, thrombosis, or any condition that hindered exercise,
- Acute or chronic cardiovascular complications such as cardiac arrhythmias, ischemia, heart failure.
- Hypertension, or hypotension that hindered exercise.
- Acute or chronic musculoskeletal injuries, pain, inflammation, or deformities that hindered exercise.
- Refusal to participate in exercise. were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Exercise Group
The exercise group performed moderate-intensity aerobic exercise on a stationary bicycle ergometer for 30 minutes during hemodialysis sessions, three days a week over 12 weeks.
Additionally, the exercise group engaged in walking exercise for 30 minutes, three days a week outside of hemodialysis sessions, maintaining the heart rate between 50-60%.
The exercise group also performed isolated exercises to expand wrist vessels, including wrist and elbow flexion, extension, and rotation, repeated 10 times, 2-3 days a week outside of hemodialysis sessions.
|
Participants were randomly divided into two groups: the exercise group and the control group.
The exercise group performed moderate-intensity aerobic exercise on a stationary bicycle ergometer for 30 minutes during hemodialysis sessions, three days a week over 12 weeks.
Additionally, the exercise group engaged in walking exercise for 30 minutes, three days a week outside of hemodialysis sessions, maintaining the heart rate between 50-60%.
The exercise group also performed isolated exercises to expand wrist vessels, including wrist and elbow flexion, extension, and rotation, repeated 10 times, 2-3 days a week outside of hemodialysis sessions.
|
|
Experimental: control group
The control group did not engage in any exercise.
|
Participants were randomly divided into two groups: the exercise group and the control group.
The exercise group performed moderate-intensity aerobic exercise on a stationary bicycle ergometer for 30 minutes during hemodialysis sessions, three days a week over 12 weeks.
Additionally, the exercise group engaged in walking exercise for 30 minutes, three days a week outside of hemodialysis sessions, maintaining the heart rate between 50-60%.
The exercise group also performed isolated exercises to expand wrist vessels, including wrist and elbow flexion, extension, and rotation, repeated 10 times, 2-3 days a week outside of hemodialysis sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Baseline Vessel Diameter (mm)
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-4/35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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