Clinical trial NCT01591876: Exercise and Vascular Function in Haemodialysis Patients
Official title: The Effect of an Intra-dialytic Aerobic Exercise Intervention on Vascular Function in People Undergoing Maintenance Haemodialysis Therapy for Chronic Kidney Disease Stage 5. An Exploratory Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Kidney Disease Stage 5
Keywords: exercise
kidney disease
vascular function
haemodialysis
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
Collaborators: name: British Kidney Patients Association
First posted: 2012-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate whether a three month intra-dialytic exercise programme improves arterial function.

Detailed description: Life expectancies in haemodialysis patients are significantly shorter than the general population due to higher cardiovascular disease risk. This is mediated by higher prevalence of cardiovascular risk factors associated with chronic kidney disease and the haemodialysis procedure. Consequently ageing of the arterial system is accelerated in this condition leading to higher prevalence of arterial plaques and increased arterial stiffness.

Higher physical activity and fitness are associated with lower cardiovascular disease and all-cause mortality in haemodialysis patients and the general population. Moreover, physical inactivity is associated with increased arterial stiffness and plaques which narrow heart arteries. Worryingly the haemodialysis population is on average highly inactive with low fitness.

Current research demonstrates that exercise which improves fitness improves arterial health. Increased bloodflow during exercise stimulates the release of nitric oxide causing arteries to dilate. Regular exercise is believed to lead to beneficial remodelling of arteries and lower arterial stiffness. Exercise is reported to improve arterial function across a range of conditions. However published research regarding the possible benefits of long term aerobic exercise on arterial health in this population is conflicting. Limitations in study design, moderately high participant dropout rates and low statistical power hamper a definitive conclusion. Importantly a gold standard measure of arterial function has not been used in previously published studies.

There is ample evidence that exercise programmes in people on dialysis improve fitness, physical function, and quality of life. It is also clear that a state of higher physical activity and fitness is associated with better arterial function in the general population. It would be advantageous for reasons of health counselling to determine whether the process of improving physical fitness and activity levels may also improve arterial health in haemodialysis patients.

Eligibility criteria: Inclusion Criteria:

* Stage 5 CKD patients (GFR \<15 mL/min) receiving maintenance haemodialysis therapy
* Male or female
* Aged \>18 years
* Written informed consent

Exclusion Criteria:

* Pregnancy
* Unstable cardiovascular conditions
* Recent cerebrovascular event
* Excess inter-dialytic weight gain
* Use of corticosteroids, anabolic therapies,
* Co-morbid catabolic conditions
* Serum potassium regularly \>6mmol/L
* Recent pulmonary thromboembolism
* Psychiatric illness including anxiety, mood and untreated eating disorders
* Infection or course of antibiotics within one month of study period.
* Dementia or severe cognitive impairment.

Primary outcomes:
measure: Brachial artery flow mediated dilatation
timeFrame: Baseline and 12 week follow-up
Secondary outcomes:
measure: Aortic pulse wave velocity
timeFrame: Baseline and three month follow-up
measure: Maximal aerobic power
timeFrame: Baseline and three months
measure: Timed up-and-go
timeFrame: Baseline and three month follow-up
measure: Sit-to-stand 5
timeFrame: Baseline and 3 month follow-up
measure: Non exercise questionnaire
timeFrame: Baseline and 3 month follow-up
measure: Physical activity
timeFrame: Baseline and 3 month follow-up
measure: Kidney Disease Quality of Life Short Form (KDQOL)
timeFrame: Baseline and 3 month follow-up
measure: Duke Activity Status Index
timeFrame: Baseline and 3 months
measure: Leicester Uraemic Symptom Scale (LUSS)
timeFrame: Baseline and 3 month follow-up
Other outcomes:
Locations:
city: Airdrie
country: United Kingdom
facility: Monklands Hospital
Study officials:
affiliation: Queen Margaret University
name: Tom Mercer, Professor
role: STUDY_DIRECTOR
References: