NCT03741985

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

November 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

November 15, 2018

Status Verified

September 1, 2018

Enrollment Period

4 months

First QC Date

October 28, 2018

Last Update Submit

November 14, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Changes in diameter of AVF draining vein

    from Baseline to 3 months

  • The ratio of pre-pump arterial pressure and blood flow

    from Baseline to 3 months

  • Adverse event

    from Baseline to 3 months

  • Changes in blood flow of AVF proximal artery

    from Baseline to 3 months

  • Changes in blood flow of brachial artery

    from Baseline to 3 months

Study Arms (2)

The handgrip exercise

PLACEBO COMPARATOR

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 dumbbell exercise

EXPERIMENTAL

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

Interventions

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 handgrip 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.

The dumbbell exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2018

First Posted

November 15, 2018

Study Start

November 10, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

November 15, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations