Chronic Kidney Disease Requiring HemodialysisPEFAVNCT06960304
Effect of a Structured Physical Exercise Program on Arteriovenous Fistula Maturation for Hemodialysis in Chronic Kidney Disease Patients
A study testing Physical exercise program in people with Chronic Kidney Disease Requiring Hemodialysis, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Hemodialysis
- What is being tested?
- Physical exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePortugal
- Study dates
- 16 Jan 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- AVF in the upper limb
- No cognitive decline and ability to follow instructions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ricardo A. S. Ferreira, Bachelor's degree in Nursing contact
Clinical Trials Unit Unidade Local de Saude de Coimbra contact
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saude de Coimbra
Coimbra, Coimbra District, 3004-561
Clinical Trials Unit Unidade Local de Saude de Coimbra, +351 239 400 400 ext. 8408, ctu-cacc@ulscoimbra.min-saude.pt
About this study
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.
Read the detailed description
To undergo Hemodialysis (HD), it is essential for the patient to have Vascular Access (VA) for HD, with priority given to the creation of an Arteriovenous Fistula (AVF). The AVF is considered the ideal VA for HD due to its advantages over other types of access. However, to become functional, the AVF must go through a maturation process. Initial AVF maturation is a complex process of vascular adaptation and remodeling, driven by a significant increase in arterial blood flow into the vein. This requires dilation and structural changes in the blood vessel walls.
One of the main issues related to AVFs is primary maturation failure. It is estimated that between 28% and 53% of AVFs experience compromised maturation, which can hinder or even prevent effective long-term cannulation for hemodialysis treatment.
It is well recognized that physical exercise promotes vascular remodeling, as shown by increased capillarity in active muscles, the development of adjacent blood vessels, increased muscle strength, and greater diameter and prominence of veins. Due to its positive influence on vascular remodeling, exercise involving the AVF limb is frequently recommended by international best practice guidelines, and it has the potential to improve the AVF maturation process. However, current scientific evidence does not yet offer a consensus on the most effective type, duration, or intensity of exercise.
Nevertheless, intentional, repetitive, and sustained physical exercise has been shown to lead to vascular remodeling, which may positively impact the functional maturation of an AVF. In this context, the aim is to conduct a quantitative, experimental, and randomized study to evaluate the effect of implementing a Physical Exercise Program for the AVF limb (PEFAV), designed by a rehabilitation nursing specialist, on the AVF maturation process.
As part of the development of the research project titled "Effect of a Structured Physical Exercise Program on Arteriovenous Fistula Maturation", the research team intends to conduct a quantitative, experimental, and randomized study with an expected duration of twenty-four months. The main objective is to evaluate the effect of implementing a Physical Exercise Program for the AVF limb (PEFAV) on the maturation process of the AVF in individuals with stage 5 Chronic Kidney Disease (CKD) who have an upper limb AVF.
Participant recruitment will take place during the specialized nursing clinics for individuals with AV for HD at CHUC - HUC Campus, using a non-probability convenience sampling method. To ensure anonymity and data confidentiality, participants will be randomly assigned to either the Exercise Group (EG) or the Control Group (CG) through a computer-generated randomization sequence using the RedCap software, with a 1:1 allocation ratio.
Two in-person appointments with the participants will be required, both taking place at the specialized nursing clinics for CKD patients with AV for HD at CHUC - HUC Campus. During the first visit, participants will be provided with information about the study's objectives and procedures, and informed consent will be obtained. Following consent, data collection instruments and procedures will be applied. Participants in the EG will receive training and instruction on how to carry out the PEFAV, while those in the CG will receive only the usual recommendations regarding AVF care.
Each participant in the EG will receive a "PEFAV Follow-up Booklet," which will include illustrations and descriptions of the exercises, the number of sets and repetitions, and a section called the "Exercise Log," where participants will be asked to record, after each session, any sensations, perceived changes, or complications related to the AVF, as well as any difficulties performing the exercises.
At the second in-person visit (eight weeks after the first), data collection instruments and procedures will be applied again, and the EG's adherence to the PEFAV will be assessed.
Data collection will include: a questionnaire; grip strength testing and measurements of forearm and arm circumference; and data from the specialized nursing consultation report (physical examination and ultrasound criteria) at CHUC - HUC Campus.
All data collection procedures will follow formal and ethical research standards, ensuring that all informed participants voluntarily, anonymously, consent to take part in the study, with confidentiality maintained and no costs or harm to participants.
The ultimate goal is to increase the number of functional and clinically viable AVFs while reducing associated complications.
- Being tested
- Physical exercise program
- Keywords
- physical exercise, chronic kidney disease, hemodialysis, fistula maturation
- Medical subject headings
- Motor Activity, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise programOther
Evaluation of AVF maturation using clinical and ultrasound criteria, after applying a structured physical exercise program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (5)
Evaluation of the impact of each physical parameters in FAV maturation: Change in Handgrip Strength (kg)
The Change in Handgrip Strength will be measured: kg
Measured: 8 weeks
Evaluation of the impact of each physical parameters in FAV maturation: Change in Forearm and Upper Arm Circumference (cm)
The Change in Forearm and Upper Arm Circumference will be measured: cm
Measured: 8 weeks
Evaluation of the impact of each physical parameters in FAV maturation: Change in Rate of AVF Complications (%)
The Change in Rate of AVF Complications will be measured: %
Measured: 8 weeks
Evaluation of the impact of each physical parameters in FAV maturation: Change in Blood Flow Velocity in the Humeral Artery (mL/min)
The change in Blood Flow Velocity in the Humeral Artery will be measured: mL/min.
Measured: 8 weeks
Evaluation of adherence Rate to the Exercise Program for the AVF Limb (%)
The percentage of exercise group participants who consistently completed the program will be assessed, based on daily records and weekly phone contacts. Participants will be further classified according to different adherence levels to the physical program (low, moderate, and high), based on the number of entries in the tracking diary.
Measured: Within 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start16 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Requiring HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPE
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CTU-CACC, Unidade Local de Saúde de Coimbra, EPE
- Investigators
- Ricardo A. S. Ferreira, Bachelor's degree in Nursing, Principal investigator, Unidade Local de Saude de Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960304
- Sponsor's protocol ID
- 035 / 24 CE
- Acronym
- PEFAV
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be irreversibly anonymized and exclusively handled by researchers involved in the study.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Structured Physical Exercise Program on Arteriovenous Fistula Maturation for Hemodialysis in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT06960304
- Acronym / sponsor ID
- PEFAV / 035 / 24 CE
- Keywords
- physical exercise, chronic kidney disease, hemodialysis, fistula maturation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPEUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To undergo Hemodialysis (HD), it is essential for the patient to have Vascular Access (VA) for HD, with priority given to the creation of an Arteriovenous Fistula (AVF). The AVF is considered the ideal VA for HD due to its advantages over other types of access. However, to become functional, the AVF must go through a maturation process. Initial AVF maturation is a complex process of vascular adaptation and remodeling, driven by a significant increase in arterial blood flow into the vein. This requires dilation and structural changes in the blood vessel walls.
One of the main issues related to AVFs is primary maturation failure. It is estimated that between 28% and 53% of AVFs experience compromised maturation, which can hinder or even prevent effective long-term cannulation for hemodialysis treatment.
It is well recognized that physical exercise promotes vascular remodeling, as shown by increased capillarity in active muscles, the development of adjacent blood vessels, increased muscle strength, and greater diameter and prominence of veins. Due to its positive influence on vascular remodeling, exercise involving the AVF limb is frequently recommended by international best practice guidelines, and it has the potential to improve the AVF maturation process. However, current scientific evidence does not yet offer a consensus on the most effective type, duration, or intensity of exercise.
Nevertheless, intentional, repetitive, and sustained physical exercise has been shown to lead to vascular remodeling, which may positively impact the functional maturation of an AVF. In this context, the aim is to conduct a quantitative, experimental, and randomized study to evaluate the effect of implementing a Physical Exercise Program for the AVF limb (PEFAV), designed by a rehabilitation nursing specialist, on the AVF maturation process.
As part of the development of the research project titled "Effect of a Structured Physical Exercise Program on Arteriovenous Fistula Maturation", the research team intends to conduct a quantitative, experimental, and randomized study with an expected duration of twenty-four months. The main objective is to evaluate the effect of implementing a Physical Exercise Program for the AVF limb (PEFAV) on the maturation process of the AVF in individuals with stage 5 Chronic Kidney Disease (CKD) who have an upper limb AVF.
Participant recruitment will take place during the specialized nursing clinics for individuals with AV for HD at CHUC - HUC Campus, using a non-probability convenience sampling method. To ensure anonymity and data confidentiality, participants will be randomly assigned to either the Exercise Group (EG) or the Control Group (CG) through a computer-generated randomization sequence using the RedCap software, with a 1:1 allocation ratio.
Two in-person appointments with the participants will be required, both taking place at the specialized nursing clinics for CKD patients with AV for HD at CHUC - HUC Campus. During the first visit, participants will be provided with information about the study's objectives and procedures, and informed consent will be obtained. Following consent, data collection instruments and procedures will be applied. Participants in the EG will receive training and instruction on how to carry out the PEFAV, while those in the CG will receive only the usual recommendations regarding AVF care.
Each participant in the EG will receive a "PEFAV Follow-up Booklet," which will include illustrations and descriptions of the exercises, the number of sets and repetitions, and a section called the "Exercise Log," where participants will be asked to record, after each session, any sensations, perceived changes, or complications related to the AVF, as well as any difficulties performing the exercises.
At the second in-person visit (eight weeks after the first), data collection instruments and procedures will be applied again, and the EG's adherence to the PEFAV will be assessed.
Data collection will include: a questionnaire; grip strength testing and measurements of forearm and arm circumference; and data from the specialized nursing consultation report (physical examination and ultrasound criteria) at CHUC - HUC Campus.
All data collection procedures will follow formal and ethical research standards, ensuring that all informed participants voluntarily, anonymously, consent to take part in the study, with confidentiality maintained and no costs or harm to participants.
The ultimate goal is to increase the number of functional and clinically viable AVFs while reducing associated complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercised group | Experimental | Other: Physical exercise programThe 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- AVF in the upper limb
- No cognitive decline and ability to follow instructions
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercise programEvaluation of AVF maturation using clinical and ultrasound criteria, after applying a structured physical exercise program. | Other | Exercised group |
Primary outcome
Evaluation of AVF maturation using clinical and ultrasound criteria: Diameter of the drainage vein (mm)
Time frame: 8 weeks
-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.
Evaluation of AVF maturation using clinical and ultrasound criteria: Venous wall thickness (mm)
Time frame: 8 weeks
- 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.
Evaluation of AVF maturation using clinical and ultrasound criteria: Blood velocity (cm/sec)
Time frame: 8 weeks
- 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.
Evaluation of AVF maturation using clinical and ultrasound criteria: Blood flow volume in the humeral artery (mL/min)
Time frame: 8 weeks
- 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.
5 secondary outcomes
Evaluation of the impact of each physical parameters in FAV maturation: Change in Handgrip Strength (kg)
Time frame: 8 weeks
Evaluation of the impact of each physical parameters in FAV maturation: Change in Forearm and Upper Arm Circumference (cm)
Time frame: 8 weeks
Evaluation of the impact of each physical parameters in FAV maturation: Change in Rate of AVF Complications (%)
Time frame: 8 weeks
Evaluation of the impact of each physical parameters in FAV maturation: Change in Blood Flow Velocity in the Humeral Artery (mL/min)
Time frame: 8 weeks
Evaluation of adherence Rate to the Exercise Program for the AVF Limb (%)
Time frame: Within 7 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No. Data will be irreversibly anonymized and exclusively handled by researchers involved in the study.
Related trials for Chronic Kidney Disease Requiring Hemodialysis
Recruiting
DIALysis With EXpanded Solute Removal
Chronic Kidney Disease Requiring Hemodialysis, End-Stage Kidney Disease (ESKD)
Recruiting
Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients
Chronic Kidney Disease Requiring Hemodialysis
Recruiting
Benefits of a Renal Rehabilitation Program Adapted to Uremic Patients on Daily Hemodialysis at Low Dialysate Flow Rate.
Chronic Kidney Disease Requiring Hemodialysis, Sarcopenia
Recruiting
Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback.
Chronic Kidney Disease Requiring Hemodialysis
Active, not recruiting
Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access
Chronic Kidney Disease Requiring Hemodialysis, End Stage Renal Disease (ESRD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ricardo A. S. Ferreira, Bachelor's degree in Nursing contact
Clinical Trials Unit Unidade Local de Saude de Coimbra contact
Ricardo A. S. Ferreira, Bachelor's degree in Nursing principal investigator
Unidade Local de Saude de Coimbra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise program in people with Chronic Kidney Disease Requiring Hemodialysis, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo A. S. Ferreira, Bachelor's degree in Nursing (+351 239 400 400, ricardoferreira@ulscoimbra.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of AVF maturation using clinical and ultrasound criteria: Diameter of the drainage vein (mm) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.