Kidney Failure, ChronicNCT00492362
Trial of Aerobic Exercise in Patients Undergoing Outpatient Hemodialysis
A study testing ergometer exercise during hemodialysis and pedometer activity outside of hemodialysis in people with Kidney Failure, Chronic, run by University of Manitoba at 4 sites in Canada.
Trial summary
Randomized controlled trial comparing effects of ergometer exercise during hemodialysis to effects of pedometer use outside of hemodialysis on exercise capacity, functional status, quality of life and adequacy of hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- ergometer exercise during hemodialysis and pedometer activity outside of hemodialysis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesCanada
- Study dates
- Jul 2007to May 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult (>18 years old) patients
- Treated with hemodialysis for > 3 months
- Hemoglobin > 100 g/L over the previous 2 months
- Kt/V > 1.2 for last month and no history of shortened dialysis due to hemodialysis access issues or frequent alarming during dialysis due to poor access will be eligible for the study.
- Study patients must also be likely able to complete 12 consecutive weeks of exercise (i.e. no travel, change of modality, elective surgery planned) and must be able to comprehend instructions in English.
Who cannot join
- Acute medical illness in last month
- Unstable hemodialysis with frequent hypotension over the past month
- Active cardiovascular disease (stroke or acute coronary syndrome, unstable angina) in last 3 months
- Lower extremity amputation with no prosthesis (inability to pedal a bike)
- Spine compression fractures
- Severe musculoskeletal pain at rest or with minimal activity
Show all 9Show fewer
- Inability to sit, stand or walk unassisted (walking devices such as cane will be allowed)
- Shortness of breath at rest or with activities of daily living (NYHA Class IV)
- Labile glycemic control with hypoglycaemic episodes > 1x/week.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Sherbrook Dialysis Unit
Winnipeg, Manitoba, R3A1M2
Central Dialysis Unit, Health Sciences Centre
Winnipeg, Manitoba, R3A1R9
Seven Oaks General Hospital
Winnipeg, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba
About this study
Official title: A Randomized Controlled Trial of Aerobic Exercise in Patients With End Stage Renal Disease During Outpatient Hemodialysis
Randomized controlled trial comparing effects of ergometer exercise during hemodialysis to effects of pedometer use outside of hemodialysis on exercise capacity, functional status, quality of life and adequacy of hemodialysis.
Read the detailed description
Study Design:
Prospective, randomized, controlled trial of chronic hemodialysis outpatients within the Manitoba Renal Program.
Potential patients include any individual receiving chronic outpatient hemodialysis in Winnipeg (Seven Oaks, Sherbrook, Central and St. Boniface dialysis units) and the Brandon hemodialysis unit.
Exercise Interventions:
Patients will be block randomized to one of the following 2 interventions:
Group A: Cycling on an ergometer GOAL 60 minutes 3 times per week on hemodialysis for 24 weeks A cycling ergometer will be placed on the floor in front of the patient's dialysis chair or at the foot of the bed (if there are only beds available in that unit). The patient will be allowed to exercise anytime during the first half of each dialysis treatment. Goal frequency will be 3 times per week during their usual scheduled hemodialysis treatments.
Group B: Pedometers This group will each receive a pedometer (StepsCount®) at the onset of the study following exercise testing. They will be educated regarding the technical use of the pedometer and will receive the handout entitled "Pedometer Information Sheet: Get Physically Active One Step at a Time!" They will also receive verbal education regarding use of the pedometer and goal activity levels from the exercise study supervisor.
- Conditions
- Kidney Failure, Chronic
- Being tested
- ergometer exercise during hemodialysis, pedometer activity outside of hemodialysis
- Keywords
- hemodialysis, exercise, physical fitness, dialysis adequacy
- Medical subject headings
- Kidney Failure, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ergometer exercise during hemodialysisBehavioural
pedometer activity outside of hemodialysisBehavioural
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Ergometer during hemodialysis Receives: Behavioral: ergometer exercise during hemodialysis |
| B | Active comparator | Pedometer use outside of hemodialysis Receives: Behavioral: pedometer activity outside of hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic exercise capacity as measured by VO2 peak
Measured: 3 and 6 months
physical function as measured by sit to stand to sit; sit and reach and 6 minute walk test
Measured: 3 and 6 months
Secondary outcomes (2)
quality of life measured by SF36
Measured: 3 and 6 months
dialysis adequacy as measured by ktV
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- Clara J Bohm, MD, Principal investigator, University of Manitoba; Manitoba Renal Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492362
- Sponsor's protocol ID
- B2007:067
- Status last verified
- Jun 2008
- First submitted
- 26 Jun 2007
- Last updated
- 4 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
PubMed 35018639
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Aerobic Exercise in Patients With End Stage Renal Disease During Outpatient Hemodialysis
- ClinicalTrials.gov ID
- NCT00492362
- Acronym / sponsor ID
- B2007:067
- Conditions
- Kidney Failure, Chronic
- Keywords
- hemodialysis, exercise, physical fitness, dialysis adequacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 27 Jun 2007 (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.
Randomized controlled trial comparing effects of ergometer exercise during hemodialysis to effects of pedometer use outside of hemodialysis on exercise capacity, functional status, quality of life and adequacy of hemodialysis.
Detailed description
Study Design:
Prospective, randomized, controlled trial of chronic hemodialysis outpatients within the Manitoba Renal Program.
Potential patients include any individual receiving chronic outpatient hemodialysis in Winnipeg (Seven Oaks, Sherbrook, Central and St. Boniface dialysis units) and the Brandon hemodialysis unit.
Exercise Interventions:
Patients will be block randomized to one of the following 2 interventions:
Group A: Cycling on an ergometer GOAL 60 minutes 3 times per week on hemodialysis for 24 weeks A cycling ergometer will be placed on the floor in front of the patient's dialysis chair or at the foot of the bed (if there are only beds available in that unit). The patient will be allowed to exercise anytime during the first half of each dialysis treatment. Goal frequency will be 3 times per week during their usual scheduled hemodialysis treatments.
Group B: Pedometers This group will each receive a pedometer (StepsCount®) at the onset of the study following exercise testing. They will be educated regarding the technical use of the pedometer and will receive the handout entitled "Pedometer Information Sheet: Get Physically Active One Step at a Time!" They will also receive verbal education regarding use of the pedometer and goal activity levels from the exercise study supervisor.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: ergometer exercise during hemodialysisErgometer during hemodialysis |
| B | Active comparator | Behavioral: pedometer activity outside of hemodialysisPedometer use outside of hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All adult (>18 years old) patients
- Treated with hemodialysis for > 3 months
- Hemoglobin > 100 g/L over the previous 2 months
- Kt/V > 1.2 for last month and no history of shortened dialysis due to hemodialysis access issues or frequent alarming during dialysis due to poor access will be eligible for the study.
- Study patients must also be likely able to complete 12 consecutive weeks of exercise (i.e. no travel, change of modality, elective surgery planned) and must be able to comprehend instructions in English.
Key exclusion criteria (9 listed)
- Acute medical illness in last month
- Unstable hemodialysis with frequent hypotension over the past month
- Active cardiovascular disease (stroke or acute coronary syndrome, unstable angina) in last 3 months
- Lower extremity amputation with no prosthesis (inability to pedal a bike)
- Spine compression fractures
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 |
|---|---|---|
| ergometer exercise during hemodialysis | Behavioural | A |
| pedometer activity outside of hemodialysis | Behavioural | B |
Primary outcome
Aerobic exercise capacity as measured by VO2 peak
Time frame: 3 and 6 months
physical function as measured by sit to stand to sit; sit and reach and 6 minute walk test
Time frame: 3 and 6 months
2 secondary outcomes
quality of life measured by SF36
Time frame: 3 and 6 months
dialysis adequacy as measured by ktV
Time frame: 3 and 6 months
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 4 Jun 2008.
- Derived from this study: PubMed 35018639Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
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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.
Clara J Bohm, MD principal investigator
University of Manitoba; Manitoba Renal Program
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ergometer exercise during hemodialysis and pedometer activity outside of hemodialysis in people with Kidney Failure, Chronic, run by University of Manitoba at 4 sites 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 5 inclusion and 9 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 4 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Aerobic exercise capacity as measured by VO2 peak (time frame: 3 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00492362, which also lists 1 linked publication.
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 4 Jun 2008.