Clinical trial NCT05493046: Interactive Hand Exercise Game on Grip Strength and Vascular Maturation
Official title: Effects of Interactive Hand Exercise Game on Grip Strength and Vascular Maturation in Patients Undergoing Arteriovenous Fistula Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Muscle Weakness
Angiogenesis
Keywords: Hand-grip Strength
Hemodialysis
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Mackay Memorial Hospital
First posted: 2022-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in vein diameter
timeFrame: The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula surgery
measure: Changes in the depth of the fistula from the epidermis
timeFrame: The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.
measure: Changes in brachial artery blood flow rate
timeFrame: The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.
Secondary outcomes:
measure: Changes in grip strength
timeFrame: The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Hsiao-Yean Chiu
Study officials:
affiliation: Taipei Medical University
name: Chiu Hsiao-Yean, PhD
role: PRINCIPAL_INVESTIGATOR
References: