Exercise and Vascular Function in Haemodialysis Patients

NCT ID: NCT01591876

Last Updated: 2013-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-02-28

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.

Conditions

Chronic Kidney Disease Stage 5

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Progressive muscle relaxation

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

Group Type: SHAM_COMPARATOR

Progressive Muscle relaxation

Intervention Type: OTHER

This is a sequence of stretching and relaxation of the major muscle groups of the body. Participants are initially given detailed information regarding the technique and then provided with a recorded version which they listen to for 30-40 minutes during dialysis sessions. Participants in this group are offered the exercise programme at the end of three months.

Aerobic exercise

Intervention -moderate intensity aerobic exercise.

Group Type: ACTIVE_COMPARATOR

Intradialytic aerobic exercise

Intervention Type: OTHER

Participants in the intervention group will undertake moderate intensity aerobic exercise. Exercise modality will be recumbent cycling during the first two hours of haemodialysis sessions. Exercise prescription is set using a graded exercise test and anchored to a perceived level of exertion using the BORG scale. Training stimulus is maintained by the participant by increasing the cycling resistance when perceived exertion drops by one point at the current resistance level. Adherence and training volume is recorded during the intervention period.

Interventions

Intradialytic aerobic exercise

Participants in the intervention group will undertake moderate intensity aerobic exercise. Exercise modality will be recumbent cycling during the first two hours of haemodialysis sessions. Exercise prescription is set using a graded exercise test and anchored to a perceived level of exertion using the BORG scale. Training stimulus is maintained by the participant by increasing the cycling resistance when perceived exertion drops by one point at the current resistance level. Adherence and training volume is recorded during the intervention period.

Intervention Type: OTHER

Progressive Muscle relaxation

This is a sequence of stretching and relaxation of the major muscle groups of the body. Participants are initially given detailed information regarding the technique and then provided with a recorded version which they listen to for 30-40 minutes during dialysis sessions. Participants in this group are offered the exercise programme at the end of three months.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British Kidney Patients Association

UNKNOWN

Sponsor Role: collaborator

Queen Margaret University

OTHER

Sponsor Role: lead

Responsible Party

Sean Prescott

PhD Research Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tom Mercer, Professor

Role: STUDY_DIRECTOR

Queen Margaret University

Locations

Monklands Hospital

Airdrie, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Sean Prescott, MSc

Role: CONTACT

sprescott@qmu.ac.uk

+447980338486

Facility Contacts

Jamie Traynor, MD

Role: primary

+44 1236748748

Other Identifiers

12/WS/0129

Identifier Type: -

Identifier Source: org_study_id