Renal FailureNCT03787589
Exercise in Patients With End Stage Kidney Disease
A study testing Exercise Prescription in people with Renal Failure, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
This study will be conducted over a 3 year time period. This is a trial of an exercise intervention vs. standard of care in patients receiving chronic dialysis. The specific aims will be to determine feasibility of patient recruitment, adherence to the exercise program, and efficacy of the intervention on patient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- Exercise Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2019to 15 Sep 2025
- 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 ambulatory adult patients with end stage kidney disease
- Treatment with peritoneal dialysis or hemodialysis for greater than six months
- Able to understand English or French
- Abuse to use Nordic Walking poles
- Able and willing to provide informed consent
Who cannot join
- Any absolute contraindication to exercise [unstable angina, uncontrolled hypertension (systolic or diastolic blood pressure greater than 180 mmHg (millimeters of mercury) or greater than 110 mmHg, respectively), deemed not suitable for exercise by the treating physician]
- Baseline step count greater than 8000 steps a day
- Planned living donor kidney transplant
- Potential for recovery of renal function
- Patients who feel unsafe using Nordic walking poles in place of their mobility aid
- Participation in another interventional trial that may affect the results of this study
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Ottawa Hospital
Ottawa, Ontario, K1H 1A2
Deborah Zimmerman, MD, MSc
About this study
Official title: A Simple Exercise Program for Patients With End Stage Kidney Disease to Improve Strength and Quality of Life: A Feasibility Study
This study will be conducted over a 3 year time period. This is a trial of an exercise intervention vs. standard of care in patients receiving chronic dialysis. The specific aims will be to determine feasibility of patient recruitment, adherence to the exercise program, and efficacy of the intervention on patient important outcomes.
The exercise intervention will be delivered to randomized participants for 12 months, and consist of the prescribed use of Nordic Walking poles, online resources for exercise in the home, regular use of a pedometer to monitor progress, and regular verbal encouragement to exercise (monthly) by dialysis unit staff. Both groups will receive the same standard of care co-interventions including individualized dialysis prescriptions and health-care interactions according to practices at their centre.
- Conditions
- Renal Failure
- Being tested
- Exercise Prescription
- Keywords
- Renal Failure, Hemodialysis, Peritoneal Dialysis, Exercise
- Medical subject headings
- Renal Insufficiency, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise PrescriptionBehavioural
Participants in the intervention group will be given an exercise prescription to increase their baseline steps by 1200 and 2000 steps per day at least 3 days a week over the first 3 months. If tolerated and accepted, the participants will increase their step counts by an additional 600 to 1000 steps per day at least 3 days a week for the next 3 months.This will be followed by a 6-month maintenance phase. The research coordinator will instruct the participants on the proper use of the Nordic walking poles which can be used to help participants achieve their prescribed number of steps.
All participants will be encouraged to wear the pedometer throughout the trial in order to follow the step-count prescription and monitor adherence.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Participants in this arm will receive standard of care along with the exercise prescription intervention Receives: Behavioral: Exercise Prescription |
| Standard of Care | No intervention | This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
The investigators will assess at each centre the number of participants receiving dialysis, approached for participation, eligible to participate and any reasons for non-participation.
Measured: 30 months
Adherence
Two-week step counts with a pedometer will be monitored monthly in the treatment group, and at baseline, 6 and 12 months in the control group.
Measured: 12 months
Secondary outcomes (7)
Hand Grip Strength
The investigators will measure hand grip strength at baseline, 6, and 12 months using a handgrip dynamometer in the dominant hand or in the non-arteriovenous fistula arm (best of two efforts in kgs)
Measured: 12 months
Quality of Life using Vitality Subscale
Energy will be measured with the Medical Outcomes Study 36 Item Short Form Survey Instrument - Vitality Subscale (Score 0 (lowest) -100 (highest, more energy)
Measured: 12 months
Sleep Quality
Sleep will be measured with the Pittsburgh Sleep Quality Index (Score 0-21; lower scores reflect better sleep).
Measured: 12 months
Hospitalizations
The number of hospitalizations per patient year
Measured: 12 months
Hospital Length of Stay
Average number of days spent in hospital
Measured: 12 months
Change in Living Status
Including full care (admission to a long-term care facility), need for assistance such as housekeeping, meals, bathing
Measured: 12 months
Safety of the Exercise Program
Safety will be measured by monitoring serious adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start15 Apr 2019
- Primary completion31 Jan 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
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 Renal FailureStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Deborah Zimmerman, MD, MSc, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787589
- Sponsor's protocol ID
- 618
- Status last verified
- Jun 2024
- First submitted
- 1 Oct 2018
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, manual of operations and consent form will be made available by contacting the corresponding author. De-identified patient data will be available from 12 months to 3 years after manuscript publication to researchers with methodologically sound proposals approved by the principal investigator.
Publications
Suri RS, Moist L, Lok C, Clase CM, Harris J, Reid RD, Ramsay T, Zimmerman D. A Simple Exercise Program for Patients With End-Stage Kidney Disease to Improve Strength and Quality of Life: Clinical Research Protocol. Can J Kidney Health Dis. 2023 Oct 26;10:20543581231205160. doi: 10.1177/20543581231205160. eCollection 2023.
PubMed 37901358
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Exercise Program for Patients With End Stage Kidney Disease to Improve Strength and Quality of Life: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03787589
- Acronym / sponsor ID
- 618
- Conditions
- Renal Failure
- Keywords
- Renal Failure, Hemodialysis, Peritoneal Dialysis, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 26 Dec 2018 (actual)
- 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.
This study will be conducted over a 3 year time period. This is a trial of an exercise intervention vs. standard of care in patients receiving chronic dialysis. The specific aims will be to determine feasibility of patient recruitment, adherence to the exercise program, and efficacy of the intervention on patient important outcomes.
The exercise intervention will be delivered to randomized participants for 12 months, and consist of the prescribed use of Nordic Walking poles, online resources for exercise in the home, regular use of a pedometer to monitor progress, and regular verbal encouragement to exercise (monthly) by dialysis unit staff. Both groups will receive the same standard of care co-interventions including individualized dialysis prescriptions and health-care interactions according to practices at their centre.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Exercise PrescriptionParticipants in this arm will receive standard of care along with the exercise prescription intervention |
| Standard of Care | No intervention | –This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff. |
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 ambulatory adult patients with end stage kidney disease
- Treatment with peritoneal dialysis or hemodialysis for greater than six months
- Able to understand English or French
- Abuse to use Nordic Walking poles
- Able and willing to provide informed consent
Key exclusion criteria (6 listed)
- Any absolute contraindication to exercise [unstable angina, uncontrolled hypertension (systolic or diastolic blood pressure greater than 180 mmHg (millimeters of mercury) or greater than 110 mmHg, respectively), deemed not suitable for exercise by the treating physician]
- Baseline step count greater than 8000 steps a day
- Planned living donor kidney transplant
- Potential for recovery of renal function
- Patients who feel unsafe using Nordic walking poles in place of their mobility aid
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 |
|---|---|---|
| Exercise PrescriptionParticipants in the intervention group will be given an exercise prescription to increase their baseline steps by 1200 and 2000 steps per day at least 3 days a week over the first 3 months. If tolerated and accepted, the participants will increase their step counts by an additional 600 to 1000 steps per day at least 3 days a week for the next 3 months.This will be followed by a 6-month maintenance phase. The research coordinator will instruct the participants on the proper use of the Nordic walking poles which can be used to help participants achieve their prescribed number of steps. All participants will be encouraged to wear the pedometer throughout the trial in order to follow the step-count prescription and monitor adherence. | Behavioural | Exercise Intervention |
Primary outcome
Recruitment Feasibility
Time frame: 30 months
The investigators will assess at each centre the number of participants receiving dialysis, approached for participation, eligible to participate and any reasons for non-participation.
Adherence
Time frame: 12 months
Two-week step counts with a pedometer will be monitored monthly in the treatment group, and at baseline, 6 and 12 months in the control group.
7 secondary outcomes
Hand Grip Strength
Time frame: 12 months
Quality of Life using Vitality Subscale
Time frame: 12 months
Sleep Quality
Time frame: 12 months
Hospitalizations
Time frame: 12 months
Hospital Length of Stay
Time frame: 12 months
Change in Living Status
Time frame: 12 months
Safety of the Exercise Program
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Derived from this study: PubMed 37901358Suri RS, Moist L, Lok C, Clase CM, Harris J, Reid RD, Ramsay T, Zimmerman D. A Simple Exercise Program for Patients With End-Stage Kidney Disease to Improve Strength and Quality of Life: Clinical Research Protocol. Can J Kidney Health Dis. 2023 Oct 26;10:20543581231205160. doi: 10.1177/20543581231205160. eCollection 2023.
- Individual participant dataSharing planned: Yes. The study protocol, manual of operations and consent form will be made available by contacting the corresponding author. De-identified patient data will be available from 12 months to 3 years after manuscript publication to researchers with methodologically sound proposals approved by the principal investigator.
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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.
Deborah Zimmerman, MD, MSc principal investigator
Ottawa Hospital Research Institute
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 Prescription in people with Renal Failure, run by Ottawa Hospital Research Institute 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 5 inclusion and 6 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 26 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deborah Zimmerman, MD, MSc (613-738-8400 ext. 82534, dzimmerman@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: 30 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 NCT03787589, 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 26 Jun 2024.