Chronic Kidney Disease
Conditions
Keywords
Exercise; arteriovenous fistula; chronic kidney disease
Brief 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.
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.
Interventions
OTHERPost operative progressive handgrip exercise
As soon as possible post operation the patient will commence an eight week progressive handgrip training intervention
OTHERTreatment as usual
Continue routine care, with removal of exercise information given to patients(if anye.g. do not give out squeeze balls)
Sponsors
Betsi Cadwaladr University Health Board
Bangor University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stage 4-5 chronic kidney disease, attending for arteriovenous fistula creation in forearm
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Venous Diameter. | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Handgrip Strength | 3 months |
| Handgrip Endurance | 3 months |
| Forearm Muscle Cross Sectional Area | 3 months |
Countries
United Kingdom
Participant flow
Recruitment details
Patients with stage four and five CKD attending two renal units in North Wales, UK were invited to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| Handgrip Exercise Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program | 16 |
| Treatment as Usual | 15 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Badiocephalic fistula failed | 3 | 2 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Unable to exercise following surgery | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Treatment as Usual | Handgrip Exercise | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 16 Participants | 31 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 11 | 52 years STANDARD_DEVIATION 14 | 56 years STANDARD_DEVIATION 12 |
| Region of Enrollment United Kingdom | 15 participants | 16 participants | 31 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 |
Outcome results
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).
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Handgrip Exercise | Venous Diameter. | 5.78 mm | Standard Deviation 0.51 |
| Treatment as Usual | Venous Diameter. | 6.42 mm | Standard Deviation 0.89 |
Secondary
Forearm Muscle Cross Sectional Area
Time frame: 3 months
Secondary
Handgrip Endurance
Time frame: 3 months
Secondary
Maximum Handgrip Strength
Time frame: 3 months