NCT05493046

Brief Summary

Hemodialysis is currently the most commonly used renal replacement therapy. Compared with arteriovenous graft, central venous catheter, and autologous arteriovenous fistula, the possibility of postoperative re-dredging is low and there are few complications, so isometric hand exercise training is the first choice for hemodialysis strategy. The intervention of smart technology has greatly improved the treatment effect and quality of life of patients, and it has unique advantages when applied to health care or behavior change intervention programs. This study expects to enhance hand grip strength through interactive hand exercise games combined with grip strength equipment, thereby increasing the vascular maturity of patients with postoperative autologous arteriovenous fistula, and enhancing the motivation of patients to participate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

2.3 years

First QC Date

August 4, 2022

Last Update Submit

August 12, 2025

Conditions

Keywords

Hand-grip StrengthHemodialysis

Outcome Measures

Primary Outcomes (3)

  • Changes in vein diameter

    This will be measured by using duplex ultrasound. The maturation of autologous arteriovenous fistula is defined as a cross-sectional luminal diameter of the draining vein \>6 mm.

    The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula surgery

  • Changes in the depth of the fistula from the epidermis

    The depth of the fistula from the epidermis is measured using duplex ultrasound. The maturation of autologous arteriovenous fistula should be \<0.6 cm from the epidermis.

    The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.

  • Changes in brachial artery blood flow rate

    The flow rate is measured using duplex ultrasound. The maturation of autologous arteriovenous fistula is defined as a flow velocity in the artery \>600 ml/min.

    The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.

Secondary Outcomes (1)

  • Changes in grip strength

    The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.

Study Arms (2)

Interactive Hand Exercise Game

EXPERIMENTAL

Participants will receive an Interactive Hand Exercise Game for 30 minutes every day for consecutive two months.

Behavioral: Interactive Hand Exercise Game

Soft ball exercise ( routine care)

ACTIVE COMPARATOR

Participants will receive a soft ball exercise for 30 minutes every day for consecutive two months.

Behavioral: Soft ball exercise ( routine care)

Interventions

Interactive Hand Exercise Game to Improve Vascular Maturity and Grip Strength in Patients undergoing Arteriovenous Fistula Surgery

Interactive Hand Exercise Game

Soft ball exercise ( routine care)

Soft ball exercise ( routine care)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of chronic renal failure stage 4 to 5 (before dialysis) and stage 5 (patients who have started hemodialysis).
  • Newly established surgical patients with autologous arteriovenous fistula.
  • Aged between 20 and 70 years old.
  • Having clear consciousness and being able to communicate in Chinese.

You may not qualify if:

  • Previous dysfunction of an autologous arteriovenous fistula in the same arm.
  • Injury to the fistula extremity.
  • Neuromusculoskeletal abnormalities.
  • Upper extremity arthritis.
  • Peripheral neuropathy.
  • Peripheral arterial dysfunction.
  • Venous disease.
  • Rheumatic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hsiao-Yean Chiu

Taipei, 110, Taiwan

Location

Related Publications (1)

  • Luo YC, Han PH, Chen YY, Wu PC, Wu IW, Fan YC, Chiu HY. Effects of Interactive Handgrip Game on Vascular Maturation and Grip Strength in Patients Undergoing Arteriovenous Fistula Surgery: A Feasibility Randomized Controlled Trial. Hemodial Int. 2026 Jan 1. doi: 10.1111/hdi.70045. Online ahead of print.

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Chiu Hsiao-Yean, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor will be unaware of the treatment assignment before the completion of the study
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 9, 2022

Study Start

August 10, 2022

Primary Completion

November 20, 2024

Study Completion

November 20, 2024

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations