NCT06428773

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2024

Completed
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

May 9, 2024

Last Update Submit

June 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Baseline Vessel Diameter (mm)

    12 weeks

Study Arms (2)

Exercise Group

ACTIVE COMPARATOR

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.

Other: Exercise

control group

EXPERIMENTAL

The control group did not engage in any exercise.

Other: Exercise

Interventions

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.

Exercise Groupcontrol group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, Kırşehir, 40100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pilot Project Manager Lecturer Doctor.

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 24, 2024

Study Start

May 5, 2024

Primary Completion

September 10, 2024

Study Completion

November 12, 2024

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations