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

March 9, 2023 updated by: Chia Jung Hsieh, National Taipei University of Nursing and Health Sciences

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
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
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.
Other: Control group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, pre-intervention (T0)
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
Baseline and Weeks 2 (T1)
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
Baseline and Weeks 4 (T2)
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
Baseline and Weeks 8 (T3)
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.
Baseline, post-intervention(T1)
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.
Baseline and Weeks 4(T2)
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.
Baseline and Weeks 8(T3)
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.
Baseline, two weeks after intervention(T1)
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.
Baseline and Weeks 4(T2)
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.
Baseline and Weeks 8(T3)
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.
Baseline, before exercise intervention(T0)
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.
Baseline and Weeks 2 (T1)
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.
Baseline and Weeks 4(T2)
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.
Baseline and Weeks 8 (T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, two weeks after intervention(T1)
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.
Baseline and Weeks 4(T2)
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.
Baseline and Weeks 8(T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taipei University of Nursing and Health Sciences

Collaborators

Taipei Veterans General Hospital, Taiwan
Taiwan Nurses Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

November 24, 2022

First Submitted That Met QC Criteria

January 8, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTUNHS-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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