Effect of Dumbbell Exercise on Arteriovenous Fistula in Patients With Hemodialysis

Effect of Dumbbell Exercise on Arteriovenous Fistula in Patients With Hemodialysis：A Prospective Randomized,Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Arteriovenous Fistula
• Intervention / Treatment: Behavioral: The handgrip exercise; Behavioral: The dumbbell exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 10, 2018
• Primary Completion (Anticipated): February 28, 2019
• Study Completion (Anticipated): February 28, 2019

Study Registration Dates

• First Submitted: October 28, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: GDREC2016329H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No