The Effect of Intelligent Forearm Isometric Exercise on Vascular Function, Hand Grip Strength and Adherence in Patients With First Autologous Arteriovenous Fistula After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change from Baseline Ultrasonic evaluation of arteriovenous fistula maturity at eight weeks
研究概览
简要总结
Isometric exercise can effectively promote the vascular function of arteriovenous fistula and increase hand grip strength, but patients needs to perform isometric exercises patiently. The purpose of this study want investigate the effect of using individual intelligent devices for forearm isometric exercise training on the increase of arteriovenous fistula vascular function and hand grip strength, and the improvement of patients' adherence with forearm isometric exercise.
详细描述
An arteriovenous fistula(AVF) is the most preferred and safe vascular access for long-term hemodialysis patients. Isometric exercise can effectively promote the vascular function of AVF and increase hand grip strength, but patients needs to perform isometric exercises patiently. However, the patient's disease factors, muscle soreness caused by the exercise process, etc., may easily prevent the patient from effectively performing isometric exercise every day.This study will be the first isometric exercise training intervention program for eight weeks after AVF surgery with an intelligent device in Taiwan. Investigators expect to promote the vascular function of AVF and increase hand grip strength, as well as improve participant' adherence performance after the re-intervention protocol. To construct an intelligent forearm isometric exercise, as a reference for clinical care guidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years old
- •Regular follow-up in the nephrology clinic
- •Diagnosed with chronic kidney disease at stage 5 (or 5D)
- •Expect to do the first autologous arteriovenous fistula surgery
排除标准
- •Not the first autologous arteriovenous fistula surgery
- •Have undergone percutaneous transluminal angioplasty in the arm receiving autologous arteriovenous fistula
- •Have undergone orthopedic disease-related surgery in the arm receiving autologous arteriovenous fistula
- •Have been cardiovascular events within the past 3 months
- •Have been heart function Left ventricular ejection fraction within the past 3 months <30%.
结局指标
主要结局
Change from Baseline Ultrasonic evaluation of arteriovenous fistula maturity at eight weeks
时间窗: Baseline and Weeks 8(T3)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. \<6mm, whether the inner diameter of the outflow brachiocephalic vein is \>6mm, whether the brachial artery flow rate is \>600 mL/min, and record the measured values.
Vascular function in postoperative arteriovenous fistula
时间窗: Baseline, pre-intervention (T0)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Change from Baseline Vascular function in postoperative arteriovenous fistula at four weeks
时间窗: Baseline and Weeks 4 (T2)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Change from Baseline Vascular function in postoperative arteriovenous fistula at eight weeks
时间窗: Baseline and Weeks 8 (T3)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Change from Baseline Ultrasonic evaluation of arteriovenous fistula maturity at four weeks
时间窗: Baseline and Weeks 4(T2)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. \<6mm, whether the inner diameter of the outflow brachiocephalic vein is \>6mm, whether the brachial artery flow rate is \>600 mL/min, and record the measured values.
Clinical assessment of arteriovenous fistula maturity
时间窗: Baseline, post-intervention(T1)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels \>10 cm line.
Change from Baseline Clinical assessment of arteriovenous fistula maturity at eight weeks
时间窗: Baseline and Weeks 8(T3)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels \>10 cm line.
Ultrasonic evaluation of arteriovenous fistula maturity
时间窗: Baseline, two weeks after intervention(T1)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, the vascular radiologist used the ultrasound equipment of the Philips ClearVue 550 ultrasound system (ClearVue 550, USA) to assess whether the participant's arteriovenous fistula was far from the skin. \<6mm, whether the inner diameter of the outflow brachiocephalic vein is \>6mm, whether the brachial artery flow rate is \>600 mL/min, and record the measured values.
Change from Baseline Clinical assessment of arteriovenous fistula maturity at four weeks
时间窗: Baseline and Weeks 4(T2)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, senior hemodialysis nurses assessed whether there were palpable tremors in the blood vessels of the arteriovenous fistula, and whether there were obvious visible veins and arteriovenous in the arteriovenous fistula. Fistula with or without visible vessels \>10 cm line.
Change from Baseline Vascular function in postoperative arteriovenous fistula at two weeks
时间窗: Baseline and Weeks 2 (T1)
After the participants rested for 5 minutes at the temperature of the ultrasound room set at 25°C, professional radiology technicians used ultrasonic instruments to check and record the inner diameter of the blood vessel and the peak blood flow velocity of the drainage vein of the participant's arteriovenous fistula
Hand Grip Strength
时间窗: Baseline, before exercise intervention(T0)
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0\~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Change from Baseline Hand Grip Strength at two weeks
时间窗: Baseline and Weeks 2 (T1)
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0\~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Change from Baseline Hand Grip Strength at four weeks
时间窗: Baseline and Weeks 4(T2)
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0\~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
Change from Baseline Hand Grip Strength at eight weeks
时间窗: Baseline and Weeks 8 (T3)
Grip Strength Assessment using a hydraulic hand-held dynamometer (Takei Hand Grip Dynamometer, Japan), the arm muscle strength of the participants in the non-dominant hand was assessed. The participants sits on a chair with a backrest, with the hips bent 90 degrees, feet flat on the ground, shoulders adducted, elbows bent 90 degrees, the non-dominant arm is in a neutral position, the wrist is maintained at an extension angle of 0-30 degrees, and the ulnar side is biased. Move 0\~15 degrees. A total of three measurements will be taken with a one-minute rest in between, and measurements were made in kilograms (Kg). In addition, on the 15th day after the operation, the experimental group started to use the smart grip device for forearm isometric exercise and recorded the data after grip strength training.
次要结局
- Rate of participants' exercise adherence(Baseline, two weeks after intervention(T1))
- Change from Baseline Rate of Adherence at eight weeks(Baseline and Weeks 8(T3))
- Change from Baseline Rate of Adherence at four weeks(Baseline and Weeks 4(T2))
研究者
Chia Jung Hsieh
Ph.D., RN, Associate Professor
National Taipei University of Nursing and Health Sciences