Exercise and Vascular Function in Haemodialysis Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Queen Margaret University
Sponsor:
Collaborator:
British Kidney Patients Association
Information provided by (Responsible Party):
Sean Prescott, Queen Margaret University
ClinicalTrials.gov Identifier:
NCT01591876
First received: April 30, 2012
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Chronic Kidney Disease Stage 5
Other: Intradialytic aerobic exercise
Other: Progressive Muscle relaxation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Queen Margaret University:

Primary Outcome Measures:
  • Brachial artery flow mediated dilatation [ Time Frame: Baseline and 12 week follow-up ] [ Designated as safety issue: No ]
    Brachial artery diameter is measured using vascular ultrasound. A cuff similar to that used for blood pressure is then inflated around the forearm for 5 minutes. Following cuff release vascular ultrasound is used to measure arterial dilation in response to reactive hyperaemia. Relative change in diameter provides a measure of endothelial function. Images are recorded over a period of 4-5 minutes post cuff release.


Secondary Outcome Measures:
  • Aortic pulse wave velocity [ Time Frame: Baseline and three month follow-up ] [ Designated as safety issue: No ]
    Aortic pulse wave velocity is measured using a Vicorder (Skidmore Medical, Bristol UK). Briefly the Vicorder measures the time taken for a pulse wave to travel between a pressure cuff located on the carotid artery and another at the site of the femoral artery. The calculated velocity of the pulse wave is a measure of central arterial stiffness.

  • Maximal aerobic power [ Time Frame: Baseline and three months ] [ Designated as safety issue: No ]
    Peak aerobic power is assessed using a graded exercise test with respiratory gas analysis. An Astrand protocol will be used with cycle ergometry. Participants continue until volitional exhaustion or the test is terminated by the investigator. An oxygen uptake figure in ml/kg/min is a measure of peak aerobic power (VO2peak)

  • Timed up-and-go [ Time Frame: Baseline and three month follow-up ] [ Designated as safety issue: No ]
    The time taken to stand up from a chair, walk three metres and return is recorded. This is a functional measure of mobility with a threshold time related to falls and fractures.

  • Sit-to-stand 5 [ Time Frame: Baseline and 3 month follow-up ] [ Designated as safety issue: No ]
    The time taken to stand up from a chair five times without using upper limb assistance is recorded. This is a surrogate measure of lower limb power with a threshold that is related to balance and risk of falls.

  • Non exercise questionnaire [ Time Frame: Baseline and 3 month follow-up ] [ Designated as safety issue: No ]
    A non-exercise questionnaire utilising anthropometry, gender and self reported physical activity will be used to estimate aerobic fitness. This method carries minimal burden compared to physical performance tests and is a useful screening tool for health counselling.

  • Physical activity [ Time Frame: Baseline and 3 month follow-up ] [ Designated as safety issue: No ]
    Physical activity over a seven day period will be measured using an Actigraph accelerometer. The monitor measures body movement as activity counts which may be categorised according to level of intensity using established cut-points.

  • Kidney Disease Quality of Life Short Form (KDQOL) [ Time Frame: Baseline and 3 month follow-up ] [ Designated as safety issue: No ]
    The KDQOL is a self-administered questionnaire designed to measure generic health related quality life as well as condition specific items. Higher scores indicate better quality of life.

  • Duke Activity Status Index [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    This self administered 12 item questionnaire provides a self reported measure of physical capacity. Higher scores indicate higher fitness and ability to perform activities of daily living.

  • Leicester Uraemic Symptom Scale (LUSS) [ Time Frame: Baseline and 3 month follow-up ] [ Designated as safety issue: No ]
    The LUSS provides a measure of condition related symptom burden. it records the number of symptoms, frequency and their level of intrusiveness.


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Progressive muscle relaxation
As well as usual care participants in the control arm will receive instruction in progressive muscle relaxation.
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.
Active Comparator: Aerobic exercise
Intervention -moderate intensity aerobic exercise.
Other: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591876

Contacts
Contact: Sean Prescott, MSc +447980338486 sprescott@qmu.ac.uk

Locations
United Kingdom
Monklands Hospital Recruiting
Airdrie, United Kingdom, ML6 0JS
Contact: Jamie Traynor, MD    +44 1236748748      
Sub-Investigator: Jamie Traynor, MD         
Sponsors and Collaborators
Queen Margaret University
British Kidney Patients Association
Investigators
Study Director: Tom Mercer, Professor Queen Margaret University
  More Information

No publications provided

Responsible Party: Sean Prescott, PhD Research Student, Queen Margaret University
ClinicalTrials.gov Identifier: NCT01591876     History of Changes
Other Study ID Numbers: 12/WS/0129
Study First Received: April 30, 2012
Last Updated: February 28, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen Margaret University:
exercise
kidney disease
vascular function
haemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 18, 2014