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

NCT05686200 | Completed

• 1 other identifier: NTUNHS-012
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Isometric Exercise; Arteriovenous Fistula

Keywords

vascular function; muscle strength; adherence

Outcome Measures

Primary Outcomes (14)

• 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

  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

  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

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline and Weeks 8 (T3)

Secondary Outcomes (3)

• Rate of participants' exercise adherence

  Baseline, two weeks after intervention(T1)

• Change from Baseline Rate of Adherence at four weeks

  Baseline and Weeks 4(T2)

• Change from Baseline Rate of Adherence at eight weeks

  Baseline and Weeks 8(T3)

Study Arms (2)

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.

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.

Behavioral: Forearm isometric exercise intervention program

Interventions

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.

Control group; Experimental group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Taiwan Nurses Association: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, Taipei City, 112303, Taiwan

Location

Related Publications (24)

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MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., RN, Associate Professor

Model Details: Two-group Parallel Assignment

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: January 17, 2023
• Study Start: March 8, 2023
• Primary Completion: December 31, 2024
• Study Completion: April 9, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)