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Exercise and Vascular Function in Haemodialysis Patients

Primary Purpose

Chronic Kidney Disease Stage 5

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Intradialytic aerobic exercise
Progressive Muscle relaxation
Sponsored by
Queen Margaret University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Stage 5 focused on measuring exercise, kidney disease, vascular function, haemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Monklands HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Progressive muscle relaxation

Aerobic exercise

Arm Description

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

Intervention -moderate intensity aerobic exercise.

Outcomes

Primary Outcome Measures

Brachial artery flow mediated dilatation
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
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
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
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
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
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
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)
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
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)
The LUSS provides a measure of condition related symptom burden. it records the number of symptoms, frequency and their level of intrusiveness.

Full Information

First Posted
April 30, 2012
Last Updated
February 28, 2013
Sponsor
Queen Margaret University
Collaborators
British Kidney Patients Association
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1. Study Identification

Unique Protocol Identification Number
NCT01591876
Brief Title
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

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Margaret University
Collaborators
British Kidney Patients Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 5
Keywords
exercise, kidney disease, vascular function, haemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Progressive muscle relaxation
Arm Type
Sham Comparator
Arm Description
As well as usual care participants in the control arm will receive instruction in progressive muscle relaxation.
Arm Title
Aerobic exercise
Arm Type
Active Comparator
Arm Description
Intervention -moderate intensity aerobic exercise.
Intervention Type
Other
Intervention Name(s)
Intradialytic aerobic exercise
Intervention Description
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
Intervention Name(s)
Progressive Muscle relaxation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brachial artery flow mediated dilatation
Description
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.
Time Frame
Baseline and 12 week follow-up
Secondary Outcome Measure Information:
Title
Aortic pulse wave velocity
Description
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.
Time Frame
Baseline and three month follow-up
Title
Maximal aerobic power
Description
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)
Time Frame
Baseline and three months
Title
Timed up-and-go
Description
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.
Time Frame
Baseline and three month follow-up
Title
Sit-to-stand 5
Description
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.
Time Frame
Baseline and 3 month follow-up
Title
Non exercise questionnaire
Description
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.
Time Frame
Baseline and 3 month follow-up
Title
Physical activity
Description
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.
Time Frame
Baseline and 3 month follow-up
Title
Kidney Disease Quality of Life Short Form (KDQOL)
Description
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.
Time Frame
Baseline and 3 month follow-up
Title
Duke Activity Status Index
Description
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.
Time Frame
Baseline and 3 months
Title
Leicester Uraemic Symptom Scale (LUSS)
Description
The LUSS provides a measure of condition related symptom burden. it records the number of symptoms, frequency and their level of intrusiveness.
Time Frame
Baseline and 3 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean Prescott, MSc
Phone
+447980338486
Email
sprescott@qmu.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Mercer, Professor
Organizational Affiliation
Queen Margaret University
Official's Role
Study Director
Facility Information:
Facility Name
Monklands Hospital
City
Airdrie
ZIP/Postal Code
ML6 0JS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Traynor, MD
Phone
+44 1236748748
First Name & Middle Initial & Last Name & Degree
Jamie Traynor, MD

12. IPD Sharing Statement

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Exercise and Vascular Function in Haemodialysis Patients

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