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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03741985
Other study ID # GDREC2016329H
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 10, 2018
Est. completion date February 28, 2019

Study information

Verified date September 2018
Source Guangdong General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Isometric exercise has been shown to increase the diameter and the blood flow rate of forearm veins.At present, more studies focus on the perioperative period to promote the maturation of arteriovenous fistula(AVF), while there are few reports on functional maintenance measures for the patients with maintenance hemodialysis.This study aims to explore the effect of dumbbell exercise on AVF,and evaluate whether patients can carry a 6-pound item with the fistula limb in a reasonable way.


Description:

Autologous arteriovenous fistula (AVF) is the preferred vascular access for maintenance hemodialysis patients. It is estimated that AVF accounts for 85-90% of the permanent vascular access in Chinese hemodialysis patients. With the prolongation of dialysis time, aging, and the increase of diabetes incidence, the complications of AVF are more and more common, which affect the lifetime of AVF. Therefore,self-maintenance of AVF is essential. Among them, exercise should be used throughout the entire process of AVF use for the reason that it is economical, easy to operate, and highly repeatable.The most common isometric exercise is handgrip exercise. However, there are some deficiencies in this exercise, such as lack of quantitative standards and burnout of repeated actions. As a result, this study uses quantitative dumbbells as a training tool to explore the effect of dumbbell exercise on the maintenance of AVF, and further evaluates and breaks the nursing routine of "no lifting weights" of fistula limb.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date February 28, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Patients who have established arteriovenous fistula

2. Patients whose muscle strength of the fistula limb is graded 4-5, which can overcome the 6-pound gravity and external resistance to complete the range of joint activity

3. Patients who provided informed consent.

Exclusion Criteria:

1. Left ventricular cardiac ejection fraction <30%;

2. Using a arteriovenous graft or a long-term catheter as a permanent access;

3. The diameter of the aneurysm is greater than 2 cm or the aneurysm has a risk of rupture;

4. Participation in other clinical trials at the same time;

5. Severe cardiovascular diseases and other organ complications,malignant tumors, mental illnesses, etc.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
The handgrip exercise
The control group was given routine dialysis treatment and daily handgrip exercise .Patients are asked to squeeze a rubber ring 30 times per min for altogether 20 minutes on non-dialysis days.The 20-minute exercise can be divided into 3 parts according to individual circumstances.
The dumbbell exercise
The experimental group was given routine dialysis treatment and daily dumbbell exercise .Patients are asked to hold 6-pound dumbbells to exercise 30 times per min for altogether 20 minutes on non-dialysis days.The 20-minute exercise can be divided into 3 parts according to individual circumstances.

Locations

Country Name City State
China Guangdong General Hospital Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in blood flow of AVF draining vein The blood flow measurement was repeated three times at a location 5 cm proximal to the anastomosis in the draining vein by Doppler ultrasound. from Baseline to 3 months
Secondary Changes in diameter of AVF draining vein The diameter measurement was repeated three times at a location 5 cm proximal to the anastomosis in the draining vein by Doppler ultrasound. from Baseline to 3 months
Secondary The ratio of pre-pump arterial pressure and blood flow The ratio of pre-pump arterial pressure and blood flow during the hemodialysis treatment. from Baseline to 3 months
Secondary Adverse event The incidence of adverse event(puncture site hematoma,hemorrhage,aneurysm,heart failure,joint sprain,falls,anastomotic rupture,etc). from Baseline to 3 months
Secondary Changes in blood flow of AVF proximal artery The blood flow measurement was repeated three times at a location 5 cm proximal to the anastomosis in the proximal artery by Doppler ultrasound. from Baseline to 3 months
Secondary Changes in blood flow of brachial artery The blood flow measurement was repeated three times at a location 2 cm above the elbow in the brachial artery by Doppler ultrasound. from Baseline to 3 months
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