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| ID | Type | Description | Link |
|---|---|---|---|
| Macdonald 07/4 | Other Identifier | R & D Reference No |
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| Name | Class |
|---|---|
| Betsi Cadwaladr University Health Board | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Handgrip exercise | Experimental | Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program |
|
| Treatment as usual | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post operative progressive handgrip exercise | Other | As soon as possible post operation the patient will commence an eight week progressive handgrip training intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Handgrip Strength | 3 months | |
| Handgrip Endurance | 3 months | |
| Forearm Muscle Cross Sectional Area |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust | Bangor | Gwynedd | LL57 2PW | United Kingdom |
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Patients with stage four and five CKD attending two renal units in North Wales, UK were invited to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Handgrip Exercise | Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program |
| FG001 | Treatment as Usual |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Handgrip Exercise | Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program |
| BG001 | Treatment as Usual |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | mm | 3 months |
|
8 weeks
Including joint, muscle or wound pain was recorded by the patient and also collected actively by the researcher during each weekly phone call to the patient. Other unexpected and serious (fatal, life threatening, or resulted in hospitalization) harms were collected passively as they occurred and during the trial period only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Handgrip Exercise | Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jamie Macdonald | UWalesBangor | +441248383272 | j.h.macdonald@bangor.ac.uk |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D009043 | Motor Activity |
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual | Other | Continue routine care, with removal of exercise information given to patients(if anye.g. do not give out squeeze balls) |
|
| 3 months |
| Withdrawal by Subject |
|
| Unable to exercise following surgery |
|
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Treatment as Usual |
|
|
| Secondary | Maximum Handgrip Strength | Not Posted | 3 months |
| Secondary | Handgrip Endurance | Not Posted | 3 months |
| Secondary | Forearm Muscle Cross Sectional Area | Not Posted | 3 months |
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | Treatment as Usual | 0 | 9 | 0 | 9 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |