Chronic Kidney DiseaseNCT01061008
Handgrip Exercise for Arteriovenous Fistula Maturation
A study testing Post operative progressive handgrip exercise and Treatment as usual in people with Chronic Kidney Disease, run by Bangor University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate whether post operative progressive forearm exercise is effective in improving arteriovenous fistula maturation in chronic kidney disease patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Post operative progressive handgrip exercise and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2008to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Stage 4-5 chronic kidney disease, attending for arteriovenous fistula creation in forearm
Who cannot join
- Are under the age of 18years;
- Not able to exercise forearm safely (as decided by the patients consultant)
- Have any other uncontrolled medical condition
- Unable to withstand transiently raised systolic blood pressure by 35 mmHg and diastolic by 25 mmHg
- Or are unable to give consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust
Bangor, Gwynedd, LL57 2PW
About this study
Official title: The Effects of Progressive Handgrip Exercise Training on Arteriovenous Fistula Maturation in Chronic Kidney Disease
The purpose of this study is to investigate whether post operative progressive forearm exercise is effective in improving arteriovenous fistula maturation in chronic kidney disease patients.
Read the detailed description
The arteriovenous fistula is considered to be the gold standard form of access for haemodialysis patients, however only 37% of haemodialysis patients have this form of access. A possible explanation for this could be the high fistula failure rate due to the lack of maturation. Therefore interventions aimed at enhancing fistula maturation are warranted. One such intervention could be forearm exercise, however this recommendation is not evidence based. Therefore, the purpose of this study is to investigate whether a program of post operative progressive hand grip exercise can improve fistula maturation.
- Conditions
- Chronic Kidney Disease
- Being tested
- Post operative progressive handgrip exercise, Treatment as usual
- Keywords
- Exercise; arteriovenous fistula; chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post operative progressive handgrip exerciseOther
As soon as possible post operation the patient will commence an eight week progressive handgrip training intervention
Treatment as usualOther
Continue routine care, with removal of exercise information given to patients(if anye.g. do not give out squeeze balls)
| Study group | Role | What they receive |
|---|---|---|
| Handgrip exercise | Experimental | Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program Receives: Other: Post operative progressive handgrip exercise |
| Treatment as usual | Active comparator | Not described Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous Diameter.
Measurements were made using duplex ultrasonagraphy. Measurements were made at predetermined distances 5 to 10 cm proximal to the anastomosis (dependent on wound dressings and turbulent flow around the anastomosis). The scanning position for each patient was traced using transparent sheets which allowed analogous measurement positions for all scans. Cross sectional vascular diameter measurements were made using conventional grey scale B Mode imaging. Diameters were measured from the inner edges of the vascular wall (Wiese \& Nonnast-Daniel, 2004).
Measured: 3 months
Secondary outcomes (3)
Maximum Handgrip Strength
Measured: 3 months
Handgrip Endurance
Measured: 3 months
Forearm Muscle Cross Sectional Area
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startJan 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangor University
- Sponsor type
- University, hospital or other
- Collaborators
- Betsi Cadwaladr University Health Board
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061008
- Sponsor's protocol ID
- REC No : 07/WNo01/4
- Other IDs
- Macdonald 07/4
- Status last verified
- Jun 2014
- First submitted
- 22 Jan 2010
- Last updated
- 15 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Progressive Handgrip Exercise Training on Arteriovenous Fistula Maturation in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01061008
- Acronym / sponsor ID
- REC No : 07/WNo01/4
- Conditions
- Chronic Kidney Disease
- Keywords
- Exercise; arteriovenous fistula; chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Bangor UniversityUniversity, hospital or other
- Collaborators
- Betsi Cadwaladr University Health Board
- Study start
- Jan 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Posted 15 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether post operative progressive forearm exercise is effective in improving arteriovenous fistula maturation in chronic kidney disease patients.
Detailed description
The arteriovenous fistula is considered to be the gold standard form of access for haemodialysis patients, however only 37% of haemodialysis patients have this form of access. A possible explanation for this could be the high fistula failure rate due to the lack of maturation. Therefore interventions aimed at enhancing fistula maturation are warranted. One such intervention could be forearm exercise, however this recommendation is not evidence based. Therefore, the purpose of this study is to investigate whether a program of post operative progressive hand grip exercise can improve fistula maturation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Handgrip exercise | Experimental | Other: Post operative progressive handgrip exerciseHandgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program |
| Treatment as usual | Active comparator | Other: Treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stage 4-5 chronic kidney disease, attending for arteriovenous fistula creation in forearm
Key exclusion criteria (5 listed)
- Are under the age of 18years;
- Not able to exercise forearm safely (as decided by the patients consultant)
- Have any other uncontrolled medical condition
- Unable to withstand transiently raised systolic blood pressure by 35 mmHg and diastolic by 25 mmHg
- Or are unable to give consent
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 |
|---|---|---|
| Post operative progressive handgrip exerciseAs soon as possible post operation the patient will commence an eight week progressive handgrip training intervention | Other | Handgrip exercise |
| Treatment as usualContinue routine care, with removal of exercise information given to patients(if anye.g. do not give out squeeze balls) | Other | Treatment as usual |
Primary outcome
Venous Diameter.
Time frame: 3 months
Measurements were made using duplex ultrasonagraphy. Measurements were made at predetermined distances 5 to 10 cm proximal to the anastomosis (dependent on wound dressings and turbulent flow around the anastomosis). The scanning position for each patient was traced using transparent sheets which allowed analogous measurement positions for all scans. Cross sectional vascular diameter measurements were made using conventional grey scale B Mode imaging. Diameters were measured from the inner edges of the vascular wall (Wiese \& Nonnast-Daniel, 2004).
3 secondary outcomes
Maximum Handgrip Strength
Time frame: 3 months
Handgrip Endurance
Time frame: 3 months
Forearm Muscle Cross Sectional Area
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post operative progressive handgrip exercise and Treatment as usual in people with Chronic Kidney Disease, run by Bangor University at 1 site in United Kingdom.
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 1 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: finished, as of the sponsor's last update on 15 Jul 2014. 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 United Kingdom. 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. 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?
Yes. Results are posted in the registry (first posted 15 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous Diameter. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2014.