Arteriovenous FistulaNCT05686200

The Effect of Intelligent Exercise on Vascular Function, Grip Strength and Adherence in Patients With AVF After Surgery

A study testing Forearm isometric exercise intervention program in people with Arteriovenous Fistula and Isometric Exercise, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 years and older
Conditions the study is for: Arteriovenous Fistula, Isometric Exercise
What is being tested?: Forearm isometric exercise intervention program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteTaiwan
Study dates: 8 Mar 2023to 9 Apr 2025
Phase: Interventional
Are there results?: None posted in the registry

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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 20 years old
Regular follow-up in the nephrology clinic
Diagnosed with chronic kidney disease at stage 5 (or 5D)
Expect to do the first autologous arteriovenous fistula surgery

Who cannot join

Not the first autologous arteriovenous fistula surgery
Have undergone percutaneous transluminal angioplasty in the arm receiving autologous arteriovenous fistula
Have undergone orthopedic disease-related surgery in the arm receiving autologous arteriovenous fistula
Have been cardiovascular events within the past 3 months
Have been heart function Left ventricular ejection fraction within the past 3 months <30%.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Taipei University of Nursing and Health Sciences
Taipei, Taipei City, 112303

Other trials in Taiwan

About this study

Official title: The Effect of Intelligent Forearm Isometric Exercise on Vascular Function, Hand Grip Strength and Adherence in Patients With First Autologous Arteriovenous Fistula After Surgery

Isometric exercise can effectively promote the vascular function of arteriovenous fistula and increase hand grip strength, but patients needs to perform isometric exercises patiently. The purpose of this study want investigate the effect of using individual intelligent devices for forearm isometric exercise training on the increase of arteriovenous fistula vascular function and hand grip strength, and the improvement of patients' adherence with forearm isometric exercise.

Read the detailed description

An arteriovenous fistula(AVF) is the most preferred and safe vascular access for long-term hemodialysis patients. Isometric exercise can effectively promote the vascular function of AVF and increase hand grip strength, but patients needs to perform isometric exercises patiently. However, the patient's disease factors, muscle soreness caused by the exercise process, etc., may easily prevent the patient from effectively performing isometric exercise every day.This study will be the first isometric exercise training intervention program for eight weeks after AVF surgery with an intelligent device in Taiwan. Investigators expect to promote the vascular function of AVF and increase hand grip strength, as well as improve participant' adherence performance after the re-intervention protocol. To construct an intelligent forearm isometric exercise, as a reference for clinical care guidance.

Conditions: Arteriovenous Fistula, Isometric Exercise
Being tested: Forearm isometric exercise intervention program
Keywords: vascular function, muscle strength, adherence
Medical subject headings: Arteriovenous Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Forearm isometric exercise intervention programBehavioural
Experimental group using the intelligent gripper for forearm isometric exercise in the 3rd to 8th participants after operation, and using the smart mobile phone to install the forearm isometric exercise training game program software to provides an interactive and real- time exercise grip strength feedback mechanism, which are uses the interest of the participant to complete the forearm isometric exercise every day, and can implement the isometric exercise training for fistulization. Study nurses will track exercise adherence with telephone interviews 2, 4 and 8 participants after participant exercise intervention.

Study groups in NCT05686200
Study group	Role	What they receive
Experimental group	Experimental	Participants performed wrist-forearm exercise training within 2 weeks after the operation, that is, from 24 hours to 2 weeks after the operation, twice a day in the morning and evening, 3 groups each time, and each single item was repeated 5 times in each group (maintain for 5 seconds). Exercise for 40 minutes a day, use the mobile phone to install the forearm isometric exercise software program within the 3rd to 8th week, use the Bluetooth device to connect the hand-held gripper to perform the forearm isometric exercise, 2 times a day, morning and evening, and train 3 groups each time, 20 times each time , hand grip strength for 3 seconds each time, increase by 1 second per week, and rest for 90 seconds between groups. Receives: Behavioral: Forearm isometric exercise intervention program
Control group	Other	The control group began to use soft rubber balls for isometric contraction exercise from the 2nd day to the 8th week after operation. 2 times a day in the morning and evening, 3 groups of training each time, each group holds the ball for 5 minutes, and rests for 90 seconds between groups. Each grip training must be completed 20 times within 1 minute (keep 3 seconds each time in the first week) , increase by 2 seconds every week, and keep each grasping time for 10 seconds from the 5th to the 8th week. Receives: Behavioral: Forearm isometric exercise intervention program

What is being measured

The primary outcome is the main question the study is designed to answer.

Vascular function in postoperative arteriovenous fistula
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Measured: Baseline, pre-intervention (T0)
Change from Baseline Vascular function in postoperative arteriovenous fistula at two weeks
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Measured: Baseline and Weeks 2 (T1)
Change from Baseline Vascular function in postoperative arteriovenous fistula at four weeks
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Measured: Baseline and Weeks 4 (T2)
Change from Baseline Vascular function in postoperative arteriovenous fistula at eight weeks
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Measured: Baseline and Weeks 8 (T3)
Clinical assessment of arteriovenous fistula maturity
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels >10 cm line.
Measured: Baseline, post-intervention(T1)
Change from Baseline Clinical assessment of arteriovenous fistula maturity at four weeks
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels >10 cm line.
Measured: Baseline and Weeks 4(T2)
Change from Baseline Clinical assessment of arteriovenous fistula maturity at eight weeks
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels >10 cm line.
Measured: Baseline and Weeks 8(T3)
Ultrasonic evaluation of arteriovenous fistula maturity
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. <6mm, whether the inner diameter of the outflow brachiocephalic vein is >6mm, whether the brachial artery flow rate is >600 mL/min, and record the measured values.
Measured: Baseline, two weeks after intervention(T1)
Change from Baseline Ultrasonic evaluation of arteriovenous fistula maturity at four weeks
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. <6mm, whether the inner diameter of the outflow brachiocephalic vein is >6mm, whether the brachial artery flow rate is >600 mL/min, and record the measured values.
Measured: Baseline and Weeks 4(T2)
Change from Baseline Ultrasonic evaluation of arteriovenous fistula maturity at eight weeks
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. <6mm, whether the inner diameter of the outflow brachiocephalic vein is >6mm, whether the brachial artery flow rate is >600 mL/min, and record the measured values.
Measured: Baseline and Weeks 8(T3)
Hand Grip Strength
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Measured: Baseline, before exercise intervention(T0)
Change from Baseline Hand Grip Strength at two weeks
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Measured: Baseline and Weeks 2 (T1)
Change from Baseline Hand Grip Strength at four weeks
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Measured: Baseline and Weeks 4(T2)
Change from Baseline Hand Grip Strength at eight weeks
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Measured: Baseline and Weeks 8 (T3)

Secondary outcomes (3)

Rate of participants' exercise adherence
Participants began to self-register daily exercise times, each exercise group, each exercise frequency, and self-assessed daily exercise effort scores in the exercise log on the second day after the operation, and the end of the 8th week of exercise post-compute rate of adherence.
Measured: Baseline, two weeks after intervention(T1)
Change from Baseline Rate of Adherence at four weeks
Participants began to self-register daily exercise times, each exercise group, each exercise frequency, and self-assessed daily exercise effort scores in the exercise log on the second day after the operation, and the end of the 8th week of exercise post-compute rate of adherence.
Measured: Baseline and Weeks 4(T2)
Change from Baseline Rate of Adherence at eight weeks
Participants began to self-register daily exercise times, each exercise group, each exercise frequency, and self-assessed daily exercise effort scores in the exercise log on the second day after the operation, and the end of the 8th week of exercise post-compute rate of adherence.
Measured: Baseline and Weeks 8(T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Mar 20239 Apr 2025

First posted17 Jan 2023
Study start8 Mar 2023
Primary completion31 Dec 2024
Study completion9 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Arteriovenous FistulaStudies 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two-group Parallel Assignment
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05686200
Sponsor's protocol ID: NTUNHS-012
Status last verified: Dec 2025
First submitted: 24 Nov 2022
Last updated: 10 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alikari V, Tsironi M, Matziou V, Tzavella F, Stathoulis J, Babatsikou F, Fradelos E, Zyga S. The impact of education on knowledge, adherence and quality of life among patients on haemodialysis. Qual Life Res. 2019 Jan;28(1):73-83. doi: 10.1007/s11136-018-1989-y. Epub 2018 Sep 3.
PubMed 30178430
Andrade FP, Benvenutti H, da Silva KC, Rovedder PME. Effects of upper limb exercise programs on the arteriovenous fistula in patients on hemodialysis: A systematic review and meta-analysis. J Vasc Access. 2022 Sep;23(5):770-777. doi: 10.1177/11297298211001166. Epub 2021 Apr 27.
PubMed 33904355
Bohannon RW. Muscle strength: clinical and prognostic value of hand-grip dynamometry. Curr Opin Clin Nutr Metab Care. 2015 Sep;18(5):465-70. doi: 10.1097/MCO.0000000000000202.
PubMed 26147527
Collado-Mateo D, Lavin-Perez AM, Penacoba C, Del Coso J, Leyton-Roman M, Luque-Casado A, Gasque P, Fernandez-Del-Olmo MA, Amado-Alonso D. Key Factors Associated with Adherence to Physical Exercise in Patients with Chronic Diseases and Older Adults: An Umbrella Review. Int J Environ Res Public Health. 2021 Feb 19;18(4):2023. doi: 10.3390/ijerph18042023.
PubMed 33669679
Cronin J, Lawton T, Harris N, Kilding A, McMaster DT. A Brief Review of Handgrip Strength and Sport Performance. J Strength Cond Res. 2017 Nov;31(11):3187-3217. doi: 10.1519/JSC.0000000000002149.
PubMed 28820854
Fontsere N, Mestres G, Yugueros X, Lopez T, Yuguero A, Bermudez P, Gomez F, Riambau V, Maduell F, Campistol JM. Effect of a postoperative exercise program on arteriovenous fistula maturation: A randomized controlled trial. Hemodial Int. 2016 Apr;20(2):306-14. doi: 10.1111/hdi.12376. Epub 2015 Oct 20.
PubMed 26486682
Hawley-Hague H, Horne M, Skelton DA, Todd C. Review of how we should define (and measure) adherence in studies examining older adults' participation in exercise classes. BMJ Open. 2016 Jun 23;6(6):e011560. doi: 10.1136/bmjopen-2016-011560.
PubMed 27338884
Ibeas J, Roca-Tey R, Vallespin J, Moreno T, Monux G, Marti-Monros A, Del Pozo JL, Gruss E, Ramirez de Arellano M, Fontsere N, Arenas MD, Merino JL, Garcia-Revillo J, Caro P, Lopez-Espada C, Gimenez-Gaibar A, Fernandez-Lucas M, Valdes P, Fernandez-Quesada F, de la Fuente N, Hernan D, Arribas P, Sanchez de la Nieta MD, Martinez MT, Barba A; por el Grupo Espanol Multidisciplinar del Acceso Vascular (GEMAV). Spanish Clinical Guidelines on Vascular Access for Haemodialysis. Nefrologia. 2017 Nov;37 Suppl 1:1-191. doi: 10.1016/j.nefro.2017.11.004. English, Spanish.
PubMed 29248052
Kumar A/L S Katheraveloo K, Suryani Safri L, Guo Hou L, Hafiz Maliki A, Md Idris MA, Harunarashid H. Effect of isometric handgrip exercise on the size of cephalic veins in patients with stage 3 and 4 chronic kidney disease: A randomized controlled trial. J Vasc Access. 2020 May;21(3):372-378. doi: 10.1177/1129729819879314. Epub 2019 Oct 4.
PubMed 31581898
Kong S, Lee KS, Kim J, Jang SH. The effect of two different hand exercises on grip strength, forearm circumference, and vascular maturation in patients who underwent arteriovenous fistula surgery. Ann Rehabil Med. 2014 Oct;38(5):648-57. doi: 10.5535/arm.2014.38.5.648. Epub 2014 Oct 30.
PubMed 25379494
Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, Allon M, Asif A, Astor BC, Glickman MH, Graham J, Moist LM, Rajan DK, Roberts C, Vachharajani TJ, Valentini RP; National Kidney Foundation. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020 Apr;75(4 Suppl 2):S1-S164. doi: 10.1053/j.ajkd.2019.12.001. Epub 2020 Mar 12.
PubMed 32778223
Nantakool S, Srisuwan T, Reanpang T, Rerkasem K, Prasannarong M. A randomized controlled trial of the effect of postoperative hand exercise training on arteriovenous fistula maturation in patients with chronic kidney disease. J Vasc Surg. 2022 Jan;75(1):230-237. doi: 10.1016/j.jvs.2021.07.124. Epub 2021 Jul 24.
PubMed 34314831
Oprea A, Molnar A, Vladutiu D, Scridon T, Trifan C, Sacui D, Sasarman V, Mircea PA. Correlation between preoperative vein and artery diameters and arteriovenous fistula outcome in patients with end-stage renal disease. Clujul Med. 2018 Oct;91(4):399-407. doi: 10.15386/cjmed-1080. Epub 2018 Oct 30.
PubMed 30564015
Rothuizen TC, Wong C, Quax PH, van Zonneveld AJ, Rabelink TJ, Rotmans JI. Arteriovenous access failure: more than just intimal hyperplasia? Nephrol Dial Transplant. 2013 May;28(5):1085-92. doi: 10.1093/ndt/gft068. Epub 2013 Mar 29.
PubMed 23543595
Salimi F, Majd Nassiri G, Moradi M, Keshavarzian A, Farajzadegan Z, Saleki M, Nikpoor A, Ghane M. Assessment of effects of upper extremity exercise with arm tourniquet on maturity of arteriovenous fistula in hemodialysis patients. J Vasc Access. 2013 Jul-Sep;14(3):239-44. doi: 10.5301/jva.5000123. Epub 2013 Jan 3.
PubMed 23283645

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Intelligent Forearm Isometric Exercise on Vascular Function, Hand Grip Strength and Adherence in Patients With First Autologous Arteriovenous Fistula After Surgery
ClinicalTrials.gov ID: NCT05686200
Acronym / sponsor ID: NTUNHS-012
Conditions: Arteriovenous Fistula, Isometric Exercise
Keywords: vascular function, muscle strength, adherence
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: National Taipei University of Nursing and Health SciencesUniversity, hospital or other
Collaborators: Taipei Veterans General Hospital, Taiwan, Taiwan Nurses Association
Study start: 8 Mar 2023 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 9 Apr 2025 (actual)
First posted: 17 Jan 2023 (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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
Model description: Two-group Parallel Assignment

Arm	Type	Receives
Experimental group	Experimental	Behavioral: Forearm isometric exercise intervention programParticipants performed wrist-forearm exercise training within 2 weeks after the operation, that is, from 24 hours to 2 weeks after the operation, twice a day in the morning and evening, 3 groups each time, and each single item was repeated 5 times in each group (maintain for 5 seconds). Exercise for 40 minutes a day, use the mobile phone to install the forearm isometric exercise software program within the 3rd to 8th week, use the Bluetooth device to connect the hand-held gripper to perform the forearm isometric exercise, 2 times a day, morning and evening, and train 3 groups each time, 20 times each time , hand grip strength for 3 seconds each time, increase by 1 second per week, and rest for 90 seconds between groups.
Control group	Other	Behavioral: Forearm isometric exercise intervention programThe control group began to use soft rubber balls for isometric contraction exercise from the 2nd day to the 8th week after operation. 2 times a day in the morning and evening, 3 groups of training each time, each group holds the ball for 5 minutes, and rests for 90 seconds between groups. Each grip training must be completed 20 times within 1 minute (keep 3 seconds each time in the first week) , increase by 2 seconds every week, and keep each grasping time for 10 seconds from the 5th to the 8th week.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥ 20 years old
Regular follow-up in the nephrology clinic
Diagnosed with chronic kidney disease at stage 5 (or 5D)
Expect to do the first autologous arteriovenous fistula surgery

Key exclusion criteria (5 listed)

Not the first autologous arteriovenous fistula surgery
Have undergone percutaneous transluminal angioplasty in the arm receiving autologous arteriovenous fistula
Have undergone orthopedic disease-related surgery in the arm receiving autologous arteriovenous fistula
Have been cardiovascular events within the past 3 months
Have been heart function Left ventricular ejection fraction within the past 3 months <30%.

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
Forearm isometric exercise intervention programExperimental group using the intelligent gripper for forearm isometric exercise in the 3rd to 8th participants after operation, and using the smart mobile phone to install the forearm isometric exercise training game program software to provides an interactive and real- time exercise grip strength feedback mechanism, which are uses the interest of the participant to complete the forearm isometric exercise every day, and can implement the isometric exercise training for fistulization. Study nurses will track exercise adherence with telephone interviews 2, 4 and 8 participants after participant exercise intervention.	Behavioural	Control group, Experimental group

Primary outcome

Vascular function in postoperative arteriovenous fistula
Time frame: Baseline, pre-intervention (T0)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Change from Baseline Vascular function in postoperative arteriovenous fistula at two weeks
Time frame: Baseline and Weeks 2 (T1)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Change from Baseline Vascular function in postoperative arteriovenous fistula at four weeks
Time frame: Baseline and Weeks 4 (T2)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Change from Baseline Vascular function in postoperative arteriovenous fistula at eight weeks
Time frame: Baseline and Weeks 8 (T3)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Clinical assessment of arteriovenous fistula maturity
Time frame: Baseline, post-intervention(T1)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels >10 cm line.
Change from Baseline Clinical assessment of arteriovenous fistula maturity at four weeks
Time frame: Baseline and Weeks 4(T2)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels >10 cm line.
Change from Baseline Clinical assessment of arteriovenous fistula maturity at eight weeks
Time frame: Baseline and Weeks 8(T3)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels >10 cm line.
Ultrasonic evaluation of arteriovenous fistula maturity
Time frame: Baseline, two weeks after intervention(T1)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. <6mm, whether the inner diameter of the outflow brachiocephalic vein is >6mm, whether the brachial artery flow rate is >600 mL/min, and record the measured values.
Change from Baseline Ultrasonic evaluation of arteriovenous fistula maturity at four weeks
Time frame: Baseline and Weeks 4(T2)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. <6mm, whether the inner diameter of the outflow brachiocephalic vein is >6mm, whether the brachial artery flow rate is >600 mL/min, and record the measured values.
Change from Baseline Ultrasonic evaluation of arteriovenous fistula maturity at eight weeks
Time frame: Baseline and Weeks 8(T3)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. <6mm, whether the inner diameter of the outflow brachiocephalic vein is >6mm, whether the brachial artery flow rate is >600 mL/min, and record the measured values.
Hand Grip Strength
Time frame: Baseline, before exercise intervention(T0)
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Change from Baseline Hand Grip Strength at two weeks
Time frame: Baseline and Weeks 2 (T1)
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Change from Baseline Hand Grip Strength at four weeks
Time frame: Baseline and Weeks 4(T2)
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Change from Baseline Hand Grip Strength at eight weeks
Time frame: Baseline and Weeks 8 (T3)
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.

3 secondary outcomes

Rate of participants' exercise adherence
Time frame: Baseline, two weeks after intervention(T1)
Change from Baseline Rate of Adherence at four weeks
Time frame: Baseline and Weeks 4(T2)
Change from Baseline Rate of Adherence at eight weeks
Time frame: Baseline and Weeks 8(T3)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
Background: PubMed 30178430Alikari V, Tsironi M, Matziou V, Tzavella F, Stathoulis J, Babatsikou F, Fradelos E, Zyga S. The impact of education on knowledge, adherence and quality of life among patients on haemodialysis. Qual Life Res. 2019 Jan;28(1):73-83. doi: 10.1007/s11136-018-1989-y. Epub 2018 Sep 3.
Background: PubMed 33904355Andrade FP, Benvenutti H, da Silva KC, Rovedder PME. Effects of upper limb exercise programs on the arteriovenous fistula in patients on hemodialysis: A systematic review and meta-analysis. J Vasc Access. 2022 Sep;23(5):770-777. doi: 10.1177/11297298211001166. Epub 2021 Apr 27.
Background: PubMed 26147527Bohannon RW. Muscle strength: clinical and prognostic value of hand-grip dynamometry. Curr Opin Clin Nutr Metab Care. 2015 Sep;18(5):465-70. doi: 10.1097/MCO.0000000000000202.
Background: PubMed 33669679Collado-Mateo D, Lavin-Perez AM, Penacoba C, Del Coso J, Leyton-Roman M, Luque-Casado A, Gasque P, Fernandez-Del-Olmo MA, Amado-Alonso D. Key Factors Associated with Adherence to Physical Exercise in Patients with Chronic Diseases and Older Adults: An Umbrella Review. Int J Environ Res Public Health. 2021 Feb 19;18(4):2023. doi: 10.3390/ijerph18042023.
Background: PubMed 28820854Cronin J, Lawton T, Harris N, Kilding A, McMaster DT. A Brief Review of Handgrip Strength and Sport Performance. J Strength Cond Res. 2017 Nov;31(11):3187-3217. doi: 10.1519/JSC.0000000000002149.
Background: PubMed 26486682Fontsere N, Mestres G, Yugueros X, Lopez T, Yuguero A, Bermudez P, Gomez F, Riambau V, Maduell F, Campistol JM. Effect of a postoperative exercise program on arteriovenous fistula maturation: A randomized controlled trial. Hemodial Int. 2016 Apr;20(2):306-14. doi: 10.1111/hdi.12376. Epub 2015 Oct 20.
Background: PubMed 27338884Hawley-Hague H, Horne M, Skelton DA, Todd C. Review of how we should define (and measure) adherence in studies examining older adults' participation in exercise classes. BMJ Open. 2016 Jun 23;6(6):e011560. doi: 10.1136/bmjopen-2016-011560.
Background: PubMed 29248052Ibeas J, Roca-Tey R, Vallespin J, Moreno T, Monux G, Marti-Monros A, Del Pozo JL, Gruss E, Ramirez de Arellano M, Fontsere N, Arenas MD, Merino JL, Garcia-Revillo J, Caro P, Lopez-Espada C, Gimenez-Gaibar A, Fernandez-Lucas M, Valdes P, Fernandez-Quesada F, de la Fuente N, Hernan D, Arribas P, Sanchez de la Nieta MD, Martinez MT, Barba A; por el Grupo Espanol Multidisciplinar del Acceso Vascular (GEMAV). Spanish Clinical Guidelines on Vascular Access for Haemodialysis. Nefrologia. 2017 Nov;37 Suppl 1:1-191. doi: 10.1016/j.nefro.2017.11.004. English, Spanish.
Background: PubMed 31581898Kumar A/L S Katheraveloo K, Suryani Safri L, Guo Hou L, Hafiz Maliki A, Md Idris MA, Harunarashid H. Effect of isometric handgrip exercise on the size of cephalic veins in patients with stage 3 and 4 chronic kidney disease: A randomized controlled trial. J Vasc Access. 2020 May;21(3):372-378. doi: 10.1177/1129729819879314. Epub 2019 Oct 4.
Background: PubMed 25379494Kong S, Lee KS, Kim J, Jang SH. The effect of two different hand exercises on grip strength, forearm circumference, and vascular maturation in patients who underwent arteriovenous fistula surgery. Ann Rehabil Med. 2014 Oct;38(5):648-57. doi: 10.5535/arm.2014.38.5.648. Epub 2014 Oct 30.
Background: PubMed 32778223Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, Allon M, Asif A, Astor BC, Glickman MH, Graham J, Moist LM, Rajan DK, Roberts C, Vachharajani TJ, Valentini RP; National Kidney Foundation. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020 Apr;75(4 Suppl 2):S1-S164. doi: 10.1053/j.ajkd.2019.12.001. Epub 2020 Mar 12.
Background: PubMed 34314831Nantakool S, Srisuwan T, Reanpang T, Rerkasem K, Prasannarong M. A randomized controlled trial of the effect of postoperative hand exercise training on arteriovenous fistula maturation in patients with chronic kidney disease. J Vasc Surg. 2022 Jan;75(1):230-237. doi: 10.1016/j.jvs.2021.07.124. Epub 2021 Jul 24.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Dec 2025. 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 Taiwan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vascular function in postoperative arteriovenous fistula (time frame: Baseline, pre-intervention (T0)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05686200, which also lists 24 linked publications.

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 10 Dec 2025.