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

NCT ID: NCT05686200

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-08

Study Completion Date

2025-04-09

Brief Summary

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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.

Detailed Description

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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

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Arteriovenous Fistula Isometric Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-group Parallel Assignment
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Forearm isometric exercise intervention program

Intervention Type 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

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.

Group Type OTHER

Forearm isometric exercise intervention program

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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%.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

Taiwan Nurses Association

OTHER

Sponsor Role collaborator

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Chia Jung Hsieh

Ph.D., RN, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Taipei University of Nursing and Health Sciences

Taipei, Taipei City, Taiwan

Site Status

Countries

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Taiwan

References

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Other Identifiers

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NTUNHS-012

Identifier Type: -

Identifier Source: org_study_id

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