End Stage Kidney DiseaseNCT01877863
The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients
A study testing exercise in people with End Stage Kidney Disease, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this study is to explore the impact of an intradialytic exercise program on functional capacity, aerobic capacity, strength, quality of life, depression, hospitalizations and intradialytic episodes of hypotension. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- End Stage Kidney Disease
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Dec 2013
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Cardiac and hemodynamic stability
- Absence of severe musculoskeletal impairment
- Increased musculoskeletal weakness
- Vital signs within normal range for exercise
- Desire/motivated to exercise
- Clearance from nephrologist and Kinesiologist
Who cannot join
- Compromised cardiac profiles
- Hemodynamic instability
- Severe bone disease
- Medical conditions which contraindicate exercise
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore the impact of an intradialytic exercise program on functional capacity, aerobic capacity, strength, quality of life, depression, hospitalizations and intradialytic episodes of hypotension. The investigators would also like to look at the impact of exercise training over twelve weeks on hemoglobin levels as well as the clearance of potassium, phosphate and urea. Our hypothesis is that the above mentioned outcomes will positively improve over the twelve week intervention.
- Conditions
- End Stage Kidney Disease
- Being tested
- exercise
- Keywords
- intradialytic exercise, hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Also called intradialytic exercise, intradialytic biking, biking on hemodialysis
12 weeks of intradialytic biking at Borg intensity 3 - 4 for 15 to 60 minutes on each dialysis run
| Study group | Role | What they receive |
|---|---|---|
| intradialytic exercise | Experimental | baseline data prior to starting exercise program will be obtained and then compared to the data after 12 weeks of an intradialtyic biking program Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
Functional capacity is measured by the DASI score which gives an estimated V02 peak in ml/min/kg. The difference between the mean score at baseline and 12 weeks will be determined.
Measured: 12 weeks
Secondary outcomes (10)
Aerobic capacity
Aerobic capacity is measured as a function of the DASI score
Measured: 12 weeks
Strength
Strength is determined as bilateral hand grip strength (measured in kg) as well as by the 30 second sit to stand test(the number of repetitions achieved in 30 seconds). These measures are obtained at baseline and again at 12 weeks.
Measured: 12 weeks
Quality of life
The KDQOL- SF36 will be used to measure the quality of life at baseline and again at 12 weeks.
Measured: 12 weeks
Hospitalizations
The number and rate of hospitalizations will be determined prior to exercise start and during the 12 week exercise program. Length of stay is also tracked.
Measured: 12 weeks
Hypotension
Intradialytic hypotension, defined as a drop in systolic blood pressure (SBP) of 20 mmHg for patients with pre-dialysis blood pressure > 100 mmHg or a drop in SBP of 10 mmHg for patients with pre-dialysis blood pressure < = 90 mmHg. IDH with patient symptoms and nursing interventions will be obtained as well.
Measured: 12 weeks
Hemoglobin levels
The baseline hemoglobin and hemoglobin at 12 weeks will be tracked.
Measured: 12 weeks
Potassium levels
The baseline potassium and potassium at 12 weeks as well as the K gradient (pre -dialysis - dialysate K level)will be monitored.
Measured: 12 weeks
Urea removal
The baseline and 12 week pre and post dialysis urea levels will be monitored.
Measured: 12 weeks
Phosphate levels
The baseline and 12 week pre-dialysis phosphate levels will be tracked.
Measured: 12 weeks
Bioimpedance derived volume and body mass determinations
In a small subset of patients (n=10) the bioimpedance derived fluid compartments (ECF, ICF, E:I ratio) and fat free body mass will be determined at both baseline and 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jennifer MacRae, University of Calgary
- Investigators
- Jennifer MacRae, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877863
- Sponsor's protocol ID
- E-25253
- Status last verified
- Mar 2014
- First submitted
- 27 May 2013
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intradialytic Exercise on the Functional Capacity of Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01877863
- Acronym / sponsor ID
- E-25253
- Conditions
- End Stage Kidney Disease
- Keywords
- intradialytic exercise, hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- First posted
- 14 Jun 2013 (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 purpose of this study is to explore the impact of an intradialytic exercise program on functional capacity, aerobic capacity, strength, quality of life, depression, hospitalizations and intradialytic episodes of hypotension. The investigators would also like to look at the impact of exercise training over twelve weeks on hemoglobin levels as well as the clearance of potassium, phosphate and urea. Our hypothesis is that the above mentioned outcomes will positively improve over the twelve week intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intradialytic exercise | Experimental | Other: exercisebaseline data prior to starting exercise program will be obtained and then compared to the data after 12 weeks of an intradialtyic biking program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Cardiac and hemodynamic stability
- Absence of severe musculoskeletal impairment
- Increased musculoskeletal weakness
- Vital signs within normal range for exercise
- Desire/motivated to exercise
Key exclusion criteria (4 listed)
- Compromised cardiac profiles
- Hemodynamic instability
- Severe bone disease
- Medical conditions which contraindicate exercise
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 |
|---|---|---|
| exerciseAlso: intradialytic exercise, intradialytic biking, biking on hemodialysis12 weeks of intradialytic biking at Borg intensity 3 - 4 for 15 to 60 minutes on each dialysis run | Other | intradialytic exercise |
Primary outcome
Functional Capacity
Time frame: 12 weeks
Functional capacity is measured by the DASI score which gives an estimated V02 peak in ml/min/kg. The difference between the mean score at baseline and 12 weeks will be determined.
10 secondary outcomes
Aerobic capacity
Time frame: 12 weeks
Strength
Time frame: 12 weeks
Quality of life
Time frame: 12 weeks
Hospitalizations
Time frame: 12 weeks
Hypotension
Time frame: 12 weeks
Hemoglobin levels
Time frame: 12 weeks
Potassium levels
Time frame: 12 weeks
Urea removal
Time frame: 12 weeks
Phosphate levels
Time frame: 12 weeks
Bioimpedance derived volume and body mass determinations
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
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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.
Jennifer MacRae principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with End Stage Kidney Disease, run by University of Calgary at 1 site in Canada.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 20 Mar 2014. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity (time frame: 12 weeks). 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 20 Mar 2014.