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Effect of Dumbbell Exercise on Arteriovenous Fistula in Patients With Hemodialysis

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ClinicalTrials.gov Identifier: NCT03741985
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Guangdong General Hospital

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.

Condition or disease Intervention/treatment Phase
Arteriovenous Fistula Behavioral: The handgrip exercise Behavioral: The dumbbell exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Dumbbell Exercise on Arteriovenous Fistula in Patients With Hemodialysis:A Prospective Randomized,Controlled Trial
Estimated Study Start Date : November 10, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: The 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.
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.

Experimental: The 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Changes in blood flow of AVF draining vein [ Time Frame: from Baseline to 3 months ]
    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 :
  1. Changes in diameter of AVF draining vein [ Time Frame: from Baseline to 3 months ]
    The diameter measurement was repeated three times at a location 5 cm proximal to the anastomosis in the draining vein by Doppler ultrasound.

  2. The ratio of pre-pump arterial pressure and blood flow [ Time Frame: from Baseline to 3 months ]
    The ratio of pre-pump arterial pressure and blood flow during the hemodialysis treatment.

  3. Adverse event [ Time Frame: from Baseline to 3 months ]
    The incidence of adverse event(puncture site hematoma,hemorrhage,aneurysm,heart failure,joint sprain,falls,anastomotic rupture,etc).

  4. Changes in blood flow of AVF proximal artery [ Time Frame: from Baseline to 3 months ]
    The blood flow measurement was repeated three times at a location 5 cm proximal to the anastomosis in the proximal artery by Doppler ultrasound.

  5. Changes in blood flow of brachial artery [ Time Frame: from Baseline to 3 months ]
    The blood flow measurement was repeated three times at a location 2 cm above the elbow in the brachial artery by Doppler ultrasound.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741985


Locations
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China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China
Contact: xinling Liang, MD,PhD    86-13808819770    xinlingliang_ggh@163.com   
Sponsors and Collaborators
Guangdong General Hospital

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Responsible Party: Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT03741985     History of Changes
Other Study ID Numbers: GDREC2016329H
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fistula
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities