Interactive Hand Exercise Game on Grip Strength and Vascular Maturation

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05493046
• Other study ID #: 22MMHIS083e
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2022
• Est. completion date: July 2026

Study information

• Verified date: August 2022
• Source: Taipei Medical University
• Contact: Chiu Hsiao-Yean, PhD
• Phone: +886-2-27361661
• Email: hychiu0315[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angiogenesis
• Muscle Weakness

Intervention

Behavioral:
• Interactive Hand Exercise Game
Interactive Hand Exercise Game to Improve Vascular Maturity and Grip Strength in Patients undergoing Arteriovenous Fistula Surgery
• Soft ball exercise ( routine care)
Soft ball exercise ( routine care)

Locations

Country	Name	City	State
Taiwan	Hsiao-Yean Chiu	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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	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.