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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06428773
Other study ID # 2021-4/35
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 5, 2023
Est. completion date November 12, 2023

Study information

Verified date May 2024
Source Kirsehir Ahi Evran Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, 100 hemodialysis patients aged between 18-65 were examined. Participants were randomly divided into two groups: the exercise group and the control group. The exercise group performed moderate-intensity aerobic exercises for 30 minutes three times a week during hemodialysis sessions. Additionally, they engaged in walking exercises for 30 minutes three times a week outside of hemodialysis sessions, maintaining their heart rate between 50-60%. The exercise group also performed isolated exercises to expand wrist vessels 2-3 days a week outside of hemodialysis sessions. The vessel diameters of the patients were measured by ultrasound at the beginning and after 12 weeks.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 12, 2023
Est. primary completion date September 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
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.

Locations

Country Name City State
Turkey Kirsehir Ahi Evran University Kirsehir

Sponsors (1)

Lead Sponsor Collaborator
Kirsehir Ahi Evran Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Baseline Vessel Diameter (mm) 12 weeks
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