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Completed

NCT Number: NCT05493046

Interactive Hand Exercise Game on Grip Strength and Vascular Maturation

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hsiao-Yean Chiu

Taipei, 110, Taiwan

About this study

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 a postoperative autologous arteriovenous fistula, and enhancing the motivation of patients to participate.

The patients will be assigned to the experimental group and the control group by a simple random method, with 15 patients in each group. The experimental group was guided by the interactive hand exercise game program, while the control group received conventional softball exercise. Two groups of patients will start to perform hand exercises on the first day after returning home. The two groups need to perform 30 minutes each time, twice a day (once in the morning and once in the afternoon), for a total of two months. To assess the study outcomes (i.e., hand grip strength and maturation) will use self-structured questionnaires, Noblus ultrasonic machine and Jamar hydraulic grip. The measurement time points are the one week before, the first week, the fourth weeks and the eighth weeks after the autologous arteriovenous fistula operation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Interactive Hand Exercise Game

Behavioral

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

Soft ball exercise ( routine care)

Behavioral

Soft ball exercise ( routine care)

Primary outcomes

  1. Changes in vein diameter

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

    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.

  2. Changes in the depth of the fistula from the epidermis

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

    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.

  3. Changes in brachial artery blood flow rate

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

    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.

Secondary outcomes

  1. Changes in grip strength

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

    The grip strength is measured using the Jamar Grip. The size is set to 2 for women, 1 for those with smaller hands, and 3 for men.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Collaborators

  • Mackay Memorial Hospital

Registry information

Official study title

Effects of Interactive Hand Exercise Game on Grip Strength and Vascular Maturation in Patients Undergoing Arteriovenous Fistula Surgery: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2022
Registry last updated
Aug 15, 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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