Exercise and Vascular Function in Haemodialysis Patients

Queen Margaret University

Status and phase: Unknown; Phase 2

Conditions: Chronic Kidney Disease Stage 5

Treatments: Other: Intradialytic aerobic exercise; Other: Progressive Muscle relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT01591876

12/WS/0129

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Progressive muscle relaxation

Sham Comparator group

Description:

As well as usual care participants in the control arm will receive instruction in progressive muscle relaxation.

Treatment:

Other: Progressive Muscle relaxation

Aerobic exercise

Active Comparator group

Description:

Intervention -moderate intensity aerobic exercise.

Treatment:

Other: Intradialytic aerobic exercise