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Completed

NCT Number: NCT05686200

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

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Key information

Conditions

Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Isometric Exercise Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taipei University of Nursing and Health Sciences

Taipei, Taipei City, 112303, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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%.

Treatment and study plan

Forearm isometric exercise intervention program

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Secondary outcomes

  1. Rate of participants' exercise adherence

    Time frame: Baseline, two weeks after intervention(T1)

    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.

  2. Change from Baseline Rate of Adherence at four weeks

    Time frame: Baseline and Weeks 4(T2)

    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.

  3. Change from Baseline Rate of Adherence at eight weeks

    Time frame: Baseline and Weeks 8(T3)

    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.

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Collaborators

  • Taipei Veterans General Hospital, Taiwan
  • Taiwan Nurses Association

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 17, 2023
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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