Chronic Kidney Disease Stage 5Phase 2NCT01591876
Exercise and Vascular Function in Haemodialysis Patients
A Phase 2 study testing Intradialytic aerobic exercise and Progressive Muscle relaxation in people with Chronic Kidney Disease Stage 5, run by Queen Margaret University at 1 site in United Kingdom.
Trial summary
The aim of this study is to evaluate whether a three month intra-dialytic exercise programme improves arterial function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Stage 5
- What is being tested?
- Intradialytic aerobic exercise and Progressive Muscle relaxation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 5 CKD patients (GFR <15 mL/min) receiving maintenance haemodialysis therapy
- Male or female
- Aged >18 years
- Written informed consent
Who cannot join
- Pregnancy
- Unstable cardiovascular conditions
- Recent cerebrovascular event
- Excess inter-dialytic weight gain
- Use of corticosteroids, anabolic therapies,
- Co-morbid catabolic conditions
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Monklands Hospital
Airdrie, ML6 0JS
Jamie Traynor, MD, +44 1236748748
Jamie Traynor, MD
About this study
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
The aim of this study is to evaluate whether a three month intra-dialytic exercise programme improves arterial function.
Read the 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
- Being tested
- Intradialytic aerobic exercise, Progressive Muscle relaxation
- Keywords
- exercise, kidney disease, vascular function, haemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic aerobic exerciseOther
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.
Progressive Muscle relaxationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Progressive muscle relaxation | Sham comparator | As well as usual care participants in the control arm will receive instruction in progressive muscle relaxation. Receives: Other: Progressive Muscle relaxation |
| Aerobic exercise | Active comparator | Intervention -moderate intensity aerobic exercise. Receives: Other: Intradialytic aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 week follow-up
Secondary outcomes (9)
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.
Measured: Baseline and three month follow-up
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)
Measured: Baseline and three months
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.
Measured: Baseline and three month follow-up
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.
Measured: Baseline and 3 month follow-up
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.
Measured: Baseline and 3 month follow-up
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.
Measured: Baseline and 3 month follow-up
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.
Measured: Baseline and 3 month follow-up
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2013 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 5Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- British Kidney Patients Association
- Responsible party
- Principal investigator, Sean Prescott, Queen Margaret University
- Investigators
- Tom Mercer, Professor, Study director, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591876
- Sponsor's protocol ID
- 12/WS/0129
- Status last verified
- Feb 2013
- First submitted
- 30 Apr 2012
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01591876
- Acronym / sponsor ID
- 12/WS/0129
- Conditions
- Chronic Kidney Disease Stage 5
- Keywords
- exercise, kidney disease, vascular function, haemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- British Kidney Patients Association
- Study start
- Nov 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 4 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive muscle relaxation | Sham comparator | Other: Progressive Muscle relaxationAs well as usual care participants in the control arm will receive instruction in progressive muscle relaxation. |
| Aerobic exercise | Active comparator | Other: Intradialytic aerobic exerciseIntervention -moderate intensity aerobic exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage 5 CKD patients (GFR <15 mL/min) receiving maintenance haemodialysis therapy
- Male or female
- Aged >18 years
- Written informed consent
Key exclusion criteria (11 listed)
- Pregnancy
- Unstable cardiovascular conditions
- Recent cerebrovascular event
- Excess inter-dialytic weight gain
- Use of corticosteroids, anabolic therapies,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradialytic aerobic exerciseParticipants 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. | Other | Aerobic exercise |
| Progressive Muscle relaxationThis 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. | Other | Progressive muscle relaxation |
Primary outcome
Brachial artery flow mediated dilatation
Time frame: Baseline and 12 week follow-up
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.
9 secondary outcomes
Aortic pulse wave velocity
Time frame: Baseline and three month follow-up
Maximal aerobic power
Time frame: Baseline and three months
Timed up-and-go
Time frame: Baseline and three month follow-up
Sit-to-stand 5
Time frame: Baseline and 3 month follow-up
Non exercise questionnaire
Time frame: Baseline and 3 month follow-up
Physical activity
Time frame: Baseline and 3 month follow-up
Kidney Disease Quality of Life Short Form (KDQOL)
Time frame: Baseline and 3 month follow-up
Duke Activity Status Index
Time frame: Baseline and 3 months
Leicester Uraemic Symptom Scale (LUSS)
Time frame: Baseline and 3 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Mercer, Professor study director
Queen Margaret University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intradialytic aerobic exercise and Progressive Muscle relaxation in people with Chronic Kidney Disease Stage 5, run by Queen Margaret University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sean Prescott, MSc (+447980338486, sprescott@qmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery flow mediated dilatation (time frame: Baseline and 12 week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2013.