Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06960304

Effect of a Structured Physical Exercise Program on Arteriovenous Fistula Maturation for Hemodialysis in Chronic Kidney Disease Patients

Led by Unidade Local de Saúde de Coimbra, EPE · Updated on 2025-05-07

128

Participants Needed

1

Research Sites

25 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are examining whether a structured physical exercise program can improve the maturation and function of arteriovenous fistulas (AVFs) in patients with stage 5 Chronic Kidney Disease (CKD) who are preparing to start hemodialysis. AVFs are considered the best vascular access for hemodialysis, but in 28% to 53% of cases, they do not mature properly, which can complicate effective dialysis. Exercise is known to promote vascular changes, and international guidelines recommend arm exercises for AVF maturation, though the best type, intensity, and frequency are still unclear. The study randomly assigns participants to either an exercise group, which follows a structured physical exercise program focused on the AVF arm that includes progressive weight and therapeutic ball exercises, or a control group, which receives usual care recommendations without the exercise program. The intervention lasts for eight weeks, with participants in the exercise group receiving a follow-up booklet to track their sessions, sensations, and any difficulties. Both groups undergo evaluations at the start and end of the study period. Participants attend two in-person visits for data collection, including questionnaires, grip strength tests, arm circumference measurements, and clinical and ultrasound assessments of the AVF. The study measures AVF maturation through vein diameter, venous wall thickness, blood velocity, and blood flow volume in the humeral artery. Researchers also assess changes in handgrip strength, arm circumference, AVF complications, and adherence to the exercise program. The goal is to increase functional AVFs and reduce complications over the 24-month study duration.

CONDITIONS

Brief Title

Effect of a Structured Physical Exercise Program on Arteriovenous Fistula Maturation for Hemodialysis in Chronic Kidney Disease Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Presence of an arteriovenous fistula (AVF) in the upper limb
  • No cognitive decline and able to follow instructions
Not Eligible

You will not qualify if you...

  • History of previous dysfunctional arteriovenous fistula (AVF) on the same arm
  • History of injury or condition causing pain or loss of function in the AVF limb
  • Presence of musculoskeletal conditions or osteoarticular pathology (e.g., myopathy, rheumatoid arthritis)
  • Presence of neurological conditions or cardiovascular events (e.g., stroke, peripheral neuropathy)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants in the exercise group follow a structured physical exercise program for the arm with the arteriovenous fistula (AVF) for 8 weeks, while control group participants receive usual care recommendations.

2 visits (both in-person; one at start and one at 8 weeks)

Trial Site Locations

Total: 1 location

1

Unidade Local de Saude de Coimbra

Coimbra, Coimbra District, Portugal, 3004-561

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Research Team

R

Ricardo A. S. Ferreira, Bachelor's degree in Nursing

C

Clinical Trials Unit Unidade Local de Saude de Coimbra

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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