Arteriovenous FistulaNCT03741985
Effect of Dumbbell Exercise on Arteriovenous Fistula in Patients With Hemodialysis
A study testing The handgrip exercise and The dumbbell exercise in people with Arteriovenous Fistula, run by Guangdong Provincial People's Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- The handgrip exercise and The dumbbell exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong
xinling Liang, MD,PhD, 86-13808819770, xinlingliang_ggh@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Arteriovenous Fistula
- Being tested
- The handgrip exercise, The dumbbell exercise
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The handgrip exerciseBehavioural
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 exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: The dumbbell exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from Baseline to 3 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: from Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start10 Nov 2018 (estimated)
- Primary completion28 Feb 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741985
- Sponsor's protocol ID
- GDREC2016329H
- Status last verified
- Sep 2018
- First submitted
- 28 Oct 2018
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36184076
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dumbbell Exercise on Arteriovenous Fistula in Patients With Hemodialysis：A Prospective Randomized,Controlled Trial
- ClinicalTrials.gov ID
- NCT03741985
- Acronym / sponsor ID
- GDREC2016329H
- Conditions
- Arteriovenous Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 10 Nov 2018 (estimated)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The handgrip exercise | Placebo comparator | Behavioral: The handgrip exercisePatients 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 | Experimental | Behavioral: The dumbbell exercisePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The handgrip exerciseThe 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. | Behavioural | The handgrip exercise |
| The dumbbell exerciseThe 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. | Behavioural | The dumbbell exercise |
Primary outcome
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.
5 secondary outcomes
Changes in diameter of AVF draining vein
Time frame: from Baseline to 3 months
The ratio of pre-pump arterial pressure and blood flow
Time frame: from Baseline to 3 months
Adverse event
Time frame: from Baseline to 3 months
Changes in blood flow of AVF proximal artery
Time frame: from Baseline to 3 months
Changes in blood flow of brachial artery
Time frame: from Baseline to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Derived from this study: PubMed 36184076Nantakool 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The handgrip exercise and The dumbbell exercise in people with Arteriovenous Fistula, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood flow of AVF draining vein (time frame: from Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03741985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.