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

NCT06960304 | Recruiting

• 1 other identifier: 035 / 24 CE
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

For patients living with Chronic Kidney Disease who are preparing to start hemodialysis, having a well-functioning arteriovenous fistula (AVF) is essential. Although the AVF is considered the best type of vascular access, its maturation process does not always go as expected-studies show that in 28% to 53% of cases, the fistula does not mature properly, making effective dialysis more difficult. There is growing interest in using physical exercise as a way to support AVF maturation. International guidelines even recommend arm exercises for this purpose. However, there is still no clear agreement on what type of exercise, how often, or how intense it should be. This study aims to evaluate whether a structured exercise program focused on the AVF arm can help improve the fistula's development and overall function.

Conditions

Chronic Kidney Disease Requiring Hemodialysis

Keywords

physical exercise; chronic kidney disease; hemodialysis; fistula maturation

Outcome Measures

Primary Outcomes (4)

• Evaluation of AVF maturation using clinical and ultrasound criteria: Diameter of the drainage vein (mm)

  -Diameter of the drainage vein (mm). Eight weeks after the application of a physical exercise program, patients in the intervention and control groups will be evaluated through a physical examination (presence of thrill and continuous murmur, increased venous diameter, absence of complications such as stenosis or thrombosis) and ultrasound examination.

  8 weeks

• Evaluation of AVF maturation using clinical and ultrasound criteria: Venous wall thickness (mm)

  \- Venous wall thickness (mm). Eight weeks after the application of a physical exercise program, patients in the intervention and control groups will be evaluated through a physical examination (presence of thrill and continuous murmur, increased venous diameter, absence of complications such as stenosis or thrombosis) and ultrasound examination.

  8 weeks

• Evaluation of AVF maturation using clinical and ultrasound criteria: Blood velocity (cm/sec)

  \- Blood Velocity (cm/sec). Eight weeks after the application of a physical exercise program, patients in the intervention and control groups will be evaluated through a physical examination (presence of thrill and continuous murmur, increased venous diameter, absence of complications such as stenosis or thrombosis) and ultrasound examination.

  8 weeks

• Evaluation of AVF maturation using clinical and ultrasound criteria: Blood flow volume in the humeral artery (mL/min)

  \- Blood flow volume in the humeral artery (mL/min). Eight weeks after the application of a physical exercise program, patients in the intervention and control groups will be evaluated through a physical examination (presence of thrill and continuous murmur, increased venous diameter, absence of complications such as stenosis or thrombosis) and ultrasound examination.

  8 weeks

Secondary Outcomes (5)

• Evaluation of the impact of each physical parameters in FAV maturation: Change in Handgrip Strength (kg)

  8 weeks

• Evaluation of the impact of each physical parameters in FAV maturation: Change in Forearm and Upper Arm Circumference (cm)

  8 weeks

• Evaluation of the impact of each physical parameters in FAV maturation: Change in Rate of AVF Complications (%)

  8 weeks

• Evaluation of the impact of each physical parameters in FAV maturation: Change in Blood Flow Velocity in the Humeral Artery (mL/min)

  8 weeks

• Evaluation of adherence Rate to the Exercise Program for the AVF Limb (%)

  Within 7 weeks

Study Arms (2)

Exercised group

EXPERIMENTAL

The participants in this group follow a structured physical exercise program for the arm with the Arteriovenous Fistula (AVF), including progressive exercises using weights and therapeutic balls. The goal is to assess the impact of this intervention on AVF maturation and functionality.

Other: Physical exercise program

Control Group

NO INTERVENTION

The participants in this group do not follow the exercise program and only receive the usual recommendations on AVF care (standard of care).

Interventions

Physical exercise program OTHER

Evaluation of AVF maturation using clinical and ultrasound criteria, after applying a structured physical exercise program.

Exercised group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• AVF in the upper limb
• No cognitive decline and ability to follow instructions

You may not qualify if:

• History of previous dysfunctional ipsilateral AVF
• History of injury/condition causing pain or loss of function in the AVF limb
• Musculoskeletal conditions/osteoarticular pathology (e.g., myopathy, rheumatoid arthritis)
• Neurological conditions/cardiovascular events (e.g., stroke, peripheral neuropathy

Sponsors & Collaborators

• Unidade Local de Saúde de Coimbra, EPE: lead

Study Sites (1)

Unidade Local de Saude de Coimbra

Coimbra, Coimbra District, 3004-561, Portugal

RECRUITING

MeSH Terms

Conditions

Motor Activity; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Behavior; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

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

  Unidade Local de Saude de Coimbra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+351 239 400 400; ricardoferreira@ulscoimbra.min-saude.pt

Clinical Trials Unit Unidade Local de Saude de Coimbra

CONTACT

+351 239 400 400; ctu-cacc@ulscoimbra.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology Nurse Ricardo Ferreira

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 7, 2025
• Study Start: January 16, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)