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Effect of Dumbbell Exercise on Arteriovenous Fistula in Patients With Hemodialysis

Primary Purpose

Arteriovenous Fistula

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The handgrip exercise
The dumbbell exercise
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arteriovenous Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangdong General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

The handgrip exercise

The dumbbell exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
The ratio of pre-pump arterial pressure and blood flow
The ratio of pre-pump arterial pressure and blood flow during the hemodialysis treatment.
Adverse event
The incidence of adverse event(puncture site hematoma,hemorrhage,aneurysm,heart failure,joint sprain,falls,anastomotic rupture,etc).
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.
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.

Full Information

First Posted
October 28, 2018
Last Updated
November 14, 2018
Sponsor
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03741985
Brief Title
Effect of Dumbbell Exercise on Arteriovenous Fistula in Patients With Hemodialysis
Official Title
Effect of Dumbbell Exercise on Arteriovenous Fistula in Patients With Hemodialysis:A Prospective Randomized,Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2018 (Anticipated)
Primary Completion Date
February 28, 2019 (Anticipated)
Study Completion Date
February 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The handgrip exercise
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
The dumbbell exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The handgrip exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The dumbbell exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in blood flow of AVF draining vein
Description
The blood flow measurement was repeated three times at a location 5 cm proximal to the anastomosis in the draining vein by Doppler ultrasound.
Time Frame
from Baseline to 3 months
Secondary Outcome Measure Information:
Title
Changes in diameter of AVF draining vein
Description
The diameter measurement was repeated three times at a location 5 cm proximal to the anastomosis in the draining vein by Doppler ultrasound.
Time Frame
from Baseline to 3 months
Title
The ratio of pre-pump arterial pressure and blood flow
Description
The ratio of pre-pump arterial pressure and blood flow during the hemodialysis treatment.
Time Frame
from Baseline to 3 months
Title
Adverse event
Description
The incidence of adverse event(puncture site hematoma,hemorrhage,aneurysm,heart failure,joint sprain,falls,anastomotic rupture,etc).
Time Frame
from Baseline to 3 months
Title
Changes in blood flow of AVF proximal artery
Description
The blood flow measurement was repeated three times at a location 5 cm proximal to the anastomosis in the proximal artery by Doppler ultrasound.
Time Frame
from Baseline to 3 months
Title
Changes in blood flow of brachial artery
Description
The blood flow measurement was repeated three times at a location 2 cm above the elbow in the brachial artery by Doppler ultrasound.
Time Frame
from Baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have established arteriovenous fistula 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 Patients who provided informed consent. Exclusion Criteria: Left ventricular cardiac ejection fraction <30%; Using a arteriovenous graft or a long-term catheter as a permanent access; The diameter of the aneurysm is greater than 2 cm or the aneurysm has a risk of rupture; Participation in other clinical trials at the same time; Severe cardiovascular diseases and other organ complications,malignant tumors, mental illnesses, etc.
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xinling Liang, MD,PhD
Phone
86-13808819770
Email
xinlingliang_ggh@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36184076
Citation
Nantakool S, Reanpang T, Prasannarong M, Pongtam S, Rerkasem K. Upper limb exercise for arteriovenous fistula maturation in people requiring permanent haemodialysis access. Cochrane Database Syst Rev. 2022 Oct 3;10(10):CD013327. doi: 10.1002/14651858.CD013327.pub2.
Results Reference
derived

Learn more about this trial

Effect of Dumbbell Exercise on Arteriovenous Fistula in Patients With Hemodialysis

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