Clinical trial NCT05686200: The Effect of Intelligent Exercise on Vascular Function, Grip Strength and Adherence in Patients With AVF After Surgery
Official title: The Effect of Intelligent Forearm Isometric Exercise on Vascular Function, Hand Grip Strength and Adherence in Patients With First Autologous Arteriovenous Fistula After Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arteriovenous Fistula
Isometric Exercise
Keywords: vascular function
muscle strength
adherence
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
name: Taiwan Nurses Association
First posted: 2023-01-17
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group Parallel Assignment
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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%.

Primary outcomes:
measure: Vascular function in postoperative arteriovenous fistula
timeFrame: Baseline, pre-intervention (T0)
measure: Change from Baseline Vascular function in postoperative arteriovenous fistula at two weeks
timeFrame: Baseline and Weeks 2 (T1)
measure: Change from Baseline Vascular function in postoperative arteriovenous fistula at four weeks
timeFrame: Baseline and Weeks 4 (T2)
measure: Change from Baseline Vascular function in postoperative arteriovenous fistula at eight weeks
timeFrame: Baseline and Weeks 8 (T3)
measure: Clinical assessment of arteriovenous fistula maturity
timeFrame: Baseline, post-intervention(T1)
measure: Change from Baseline Clinical assessment of arteriovenous fistula maturity at four weeks
timeFrame: Baseline and Weeks 4(T2)
measure: Change from Baseline Clinical assessment of arteriovenous fistula maturity at eight weeks
timeFrame: Baseline and Weeks 8(T3)
measure: Ultrasonic evaluation of arteriovenous fistula maturity
timeFrame: Baseline, two weeks after intervention(T1)
measure: Change from Baseline Ultrasonic evaluation of arteriovenous fistula maturity at four weeks
timeFrame: Baseline and Weeks 4(T2)
measure: Change from Baseline Ultrasonic evaluation of arteriovenous fistula maturity at eight weeks
timeFrame: Baseline and Weeks 8(T3)
measure: Hand Grip Strength
timeFrame: Baseline, before exercise intervention(T0)
measure: Change from Baseline Hand Grip Strength at two weeks
timeFrame: Baseline and Weeks 2 (T1)
measure: Change from Baseline Hand Grip Strength at four weeks
timeFrame: Baseline and Weeks 4(T2)
measure: Change from Baseline Hand Grip Strength at eight weeks
timeFrame: Baseline and Weeks 8 (T3)
Secondary outcomes:
measure: Rate of participants' exercise adherence
timeFrame: Baseline, two weeks after intervention(T1)
measure: Change from Baseline Rate of Adherence at four weeks
timeFrame: Baseline and Weeks 4(T2)
measure: Change from Baseline Rate of Adherence at eight weeks
timeFrame: Baseline and Weeks 8(T3)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taipei University of Nursing and Health Sciences
state: Taipei City
Study officials:
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