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临床试验/NCT05493046
NCT05493046已完成不适用

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

Taipei Medical University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年8月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Changes in the depth of the fistula from the epidermis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes assessor will be unaware of the treatment assignment before the completion of the study

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Interactive Hand Exercise Game

Experimental

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

干预措施: Interactive Hand Exercise Game (Behavioral)

Soft ball exercise ( routine care)

Active Comparator

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

干预措施: Soft ball exercise ( routine care) (Behavioral)

结局指标

主要结局

Changes in the depth of the fistula from the epidermis

时间窗: 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.

Changes in vein diameter

时间窗: 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.

Changes in brachial artery blood flow rate

时间窗: 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.

次要结局

  • Changes in grip strength(The 1th week, the 4th weeks and the 8th weeks after the autologous arteriovenous fistula operation.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsiao-Yean Chiu

Associate Professor

Taipei Medical University

研究点 (2)

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