Interactive Hand Exercise Game on Grip Strength and Vascular Maturation

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

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Angiogenesis
• Intervention / Treatment: Behavioral: Interactive Hand Exercise Game; Behavioral: Soft ball exercise ( routine care)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Hsiao-Yean Chiu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interactive Hand Exercise Game; Participants will receive an Interactive Hand Exercise Game for 30 minutes every day for consecutive two months.	Behavioral: Interactive Hand Exercise Game; Interactive Hand Exercise Game to Improve Vascular Maturity and Grip Strength in Patients undergoing Arteriovenous Fistula Surgery
Active Comparator: Soft ball exercise ( routine care); Participants will receive a soft ball exercise for 30 minutes every day for consecutive two months.	Behavioral: Soft ball exercise ( routine care); Soft ball exercise ( routine care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in grip strength	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.	The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: Mackay Memorial Hospital
• Investigators: Principal Investigator: Chiu Hsiao-Yean, PhD, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): November 20, 2024
• Study Completion (Actual): November 20, 2024

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Hemodialysis; Hand-grip Strength
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Muscle Weakness
• Other Study ID Numbers: 22MMHIS083e

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
• product manufactured in and exported from the U.S.: No