End-stage Renal DiseaseNCT02234232
The Feasibility and Safety of an Intradialytic Exercise Program: DIALY-SIZE
A study testing Exercise in people with End-stage Renal Disease, run by University of Alberta at 1 site in Canada.
Trial summary
The primary aim of this pilot study is to evaluate the feasibility and safety of four different types of intradialytic exercise (exercise performed during dialysis) programs: resistance, aerobic, combined resistance and aerobic, and flexibility (attention control). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Dec 2014
- 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
- adult (age ≥18)
- dialysis dependent for ≥ 3 consecutive months
- receiving ≥ 3 dialysis treatments per week
- mobile (any distance and can be with the assistance of an aid)
- at least one non-prosthetic and functional limb
- stable during hemodialysis treatment (assessed by hemodialysis unit staff and the study physician)
- capable of providing consent
Who cannot join
- currently enrolled in a clinical trial
- missing an average of more than 2 shifts per month
- planned move or modality change within the next 4 months
- currently enrolled in a structured exercise program
- scheduled hospitalization for > 1 week
- any uncontrolled medical condition that would preclude participation in a low/moderate intensity exercise program (e.g. unstable angina, uncontrolled hypertension, severe valvular heart disease)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta Hospital, outpatient dialysis unit
Edmonton, Alberta, T6G 2P4
About this study
Official title: Exercise in the Dialysis Unit: a Randomized Factorial Pilot Study on the Feasibility and Safety of Intradialytic Exercise
The primary aim of this pilot study is to evaluate the feasibility and safety of four different types of intradialytic exercise (exercise performed during dialysis) programs: resistance, aerobic, combined resistance and aerobic, and flexibility (attention control). The secondary aim of the study is to estimate the effect of aerobic and resistance exercise, each compared with the attention control on: health-related quality of life, tests of physical performance, strength, and physical activity outside of the dialysis unit. The results of this study will be used to inform the planning of a full-scale efficacy study.
Read the detailed description
Recruitment: participants will be recruited by a study coordinator during their regular hemodialysis shift. This is a quaternary outpatient dialysis unit serving approximately 110 patients.
Randomization and allocation: we will use a permuted block design with randomly varied block sizes of eight and twelve. The randomization sequence will be computer generated and randomization to one of the 4 groups will be on a 1:1:1:1 ratio. Allocation is concealed in serially numbered, opaque, sealed envelopes.
Data collection: demographic data, length of time of hemodialysis, cause of ESRD, access type, comorbidities, number of medications, functional status, comorbidities, and dialysis prescription will be collected. The laboratory values and dialysis prescription will be collected from the dialysis unit chart using the most recent monthly blood-work and from the provincial laboratory repository. The amount and intensity of exercise that was performed as well as the participant's heart rate and blood pressure during the exercise session will be recorded at each exercise session. The exercise forms from each participant's dialysis session will be reviewed weekly for missing data. Forms with any empty field will be classified as incomplete and where possible, the appropriate staff will be asked to verify the query.
The occurrence of adverse events will be collected from all four randomization groups.The hemodialysis run-sheet, nursing notes, and exercise data collection form will be reviewed weekly for the occurence of adverse events. Hemodialysis unit staff and the exercise trainer have been instructed to report adverse events (defined a priori) as they occur. In addition, prior to each exercise session, participants will be asked if they have had any new health problems or symptoms since their last exercise session.
Missing data: conditional on the participant's consent, outcome data will be collected from all participants who drop out. For those participants who do not wish to be followed or who have missing data, baseline data will be carried forward.
Safety: due to the short duration and small size of this study, a formal safety and trial management board will not be established. A nephrologist who is not affiliated with the study will review all SAEs as they occur. The nephrologist will then determine if the SAE was associated with the intervention and whether the individual's participation requires modification or discontinuation.
Statistical analysis plan: descriptive statistics will be used to compare the clinical characteristics of the four groups at baseline. All analyses will follow the intention to treat principle.
Safety: in a primary analysis, adverse events will be reported as the number of events directly related to the intervention compared to control, by randomization group. In a secondary analysis, all adverse events that occurred during the study will be analyzed. The frequency of events will be compared using ANOVA or Kruskal-Wallis where appropriate, and with appropriate post-hoc tests to detect differences between randomization groups.
To explore the effect of aerobic and resistance exercise on components of HRQOL we will estimate the absolute change in score at 12 weeks relative to baseline in the physical component summary score (PCS), the mental component summary score (MCS), and the kidney-disease specific score (KDCS). We will report the absolute change in sub-scores for each of the component summary scores. We will use the same method to estimate the difference in scores on the tests of physical performance and strength. Assuming there is no statistical interaction (no indication in the literature), we will estimate the efficacy of the aerobic intervention by comparing all participants who received aerobic exercise with all groups that did not (aerobic and combined exercise groups versus resistance and control exercise groups) and similarly for the resistance-training group. Final scores will be compared using analysis of covariance (ANCOVA) adjusting for the baseline scores and both main effect terms. The final score will be presented as the adjusted difference in the means. To correct for multiple comparisons in the combined exercise group, based on the Bonferroni procedure a significance level of less than 0.025 will be considered significant. The same method will be used to analyze differences in the tests of physical functioning and strength. The interaction will be estimated in a secondary analysis. Due to the small sample size, no subgroup analysis will be performed.
- Conditions
- End-stage Renal Disease
- Being tested
- Exercise
- Keywords
- Hemodialysis, Exercise, aerobic, Exercise, resistance, Intradialytic, Randomized Controlled Trial, Safety, Quality of life, Physical performance
- 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.
ExerciseBehavioural
Also called Monark ergometers, TherapyTrainer ergometers, TheraBand Stretch Strap, The Cuff ankle weights
Each exercise will be performed during the first 2.5 hours of the participant's hemodialysis session. Exercises are semi supervised: the kinesiologist will supervise the initial three exercise sessions, any session that requires a change to the exercise prescription and on a minimum of a weekly basis.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | Cycling-participants will exercise for 15 minutes at the initial session followed by a weekly increase of 2 min and 3 seconds over 12 weeks. Participants will exercise 3 times per week and an intensity of "somewhat hard" (12-14 on the Borg scale). All exercises will be performed during hemodialysis. Receives: Behavioral: Exercise |
| Resistance | Experimental | Resistance training of lower limbs using ankle weights. Participants will complete 10-15 repetitions of 4 lower limb exercises: knee extension, straight leg raise, hip abduction, and hip flexion. Exercises will progress from 1 set of each exercise up to 3 sets of each exercise and with weight. Participants will exercise 3 times per week and an intensity of "somewhat hard" (12-14 on the Borg scale). All exercises will be performed during hemodialysis. Receives: Behavioral: Exercise |
| Combined aerobic and resistance | Experimental | Participants will complete both the aerobic (cycling) and resistance (ankle weights) exercise prescriptions. Receives: Behavioral: Exercise |
| Flexibility | Active comparator | A non-progressive flexibility regimen using a stretch band. Participants will perform 2 sets of the following exercises: seated pelvic tilt, seated calf stretch, supine hamstring stretch, and supine gluteal stretch. Participants will exercise 3 times per week and an intensity of "very light" (9 on the Borg scale). All exercises will be performed during hemodialysis. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with an adverse event
among each of the intervention groups, the number of participants with and type of adverse events will be compared to control. Adverse events are defined a priori and classified as either i. Serious adverse events (cardiac event e.g. arrhythmia, myocardial infarction; death; hospitalization; disability; any life threatening event) or ii. Adverse events (musculoskeletal injury; hypoglycemia; hypotension, defined as a decrease in systolic blood pressure by ≥20 mm Hg with symptoms or requiring an intervention during exercise; hypertension, define as a sustained elevation in blood pressure of >200 mmHg systolic or >110 diastolic; dialysis access complications (e.g. re-needling, hematosis, thrombosis); and any staff intervention beyond minimum ultrafiltration.
Measured: Change from baseline to 12 weeks
Adherence to the exercise protocol
To indicate the willingness of participants to engage in intradialytic exercise, adherence will be reported as the proportion of exercise sessions that were initiated out of the total number of sessions prescribed (defined as ≥ 70% of exercise sessions). To measure the amount of exercise that was actually performed, adherence will be defined as the number of sessions that were completed out of the total number of sessions prescribed (defined as ≥ 70% of exercise sessions). Adherence will be reported according to randomization groups.
Measured: At 12 weeks
The number of dropouts
A dropout is defined as a participant who leaves the study for any reason prior to completing the 12-week (36 session) exercise program. All reasons for drop out will be reported.
Measured: At the end of the study, 6 months
Human activity profile
To evaluate if an exercise program would influence the level of daily physical activity in this population, the difference in the amount of daily physical activity performed outside of the HD unit at baseline and at 12 weeks will be measured.
Measured: Change from baseline to 12 weeks
The number of participants who adopted the other group's exercise
Due the open nature of the dialysis unit, participants are aware of other participant's exercise assignments. To measure the effect of contamination, we will obtain this information from participants at the end of the study through an anonymized questionnaire.
Measured: Change from baseline and 12 weeks
The proportion of patients that would continue their current intradialytic exercise program after the study is over.
Defined as ≥50% of participants reporting that they would like to continue their current intradialytic exercise program after the study is over. This information will be collected at the end of the study using an anonymized questionnaire
Measured: At the end of the study, 6 months.
Secondary outcomes (5)
Health-related quality of life
Using the KDQOL SF-36, the change in the summary and component scores.
Measured: Change from baseline to 12 weeks
Physical performance
The Short Physical Performance Battery
Measured: Change from baseline to 12 weeks
The six minute walk test
Measured: Change from baseline to 12 weeks
Number of chair stands completed in 30 seconds
Measured: Change from baseline to 12 weeks
Strength, one repetition maximum
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions
- Responsible party
- Sponsor
- Investigators
- Stephanie Thompson, MD, Principal investigator, University of AlbertaScott Klarenbach, MD, Principal investigator, University of AlbertaMarcello Tonelli, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234232
- Sponsor's protocol ID
- RES0016810
- Other IDs
- RES0018218
- Status last verified
- Apr 2015
- First submitted
- 2 Sep 2014
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Thompson S, Klarenbach S, Molzahn A, Lloyd A, Gabrys I, Haykowsky M, Tonelli M. Randomised factorial mixed method pilot study of aerobic and resistance exercise in haemodialysis patients: DIALY-SIZE! BMJ Open. 2016 Sep 6;6(9):e012085. doi: 10.1136/bmjopen-2016-012085.
PubMed 27601500Bernier-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 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in the Dialysis Unit: a Randomized Factorial Pilot Study on the Feasibility and Safety of Intradialytic Exercise
- ClinicalTrials.gov ID
- NCT02234232
- Acronym / sponsor ID
- RES0016810
- Conditions
- End-stage Renal Disease
- Keywords
- Hemodialysis, Exercise, aerobic, Exercise, resistance, Intradialytic, Randomized Controlled Trial, Safety, Quality of life, Physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Sep 2014 (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 primary aim of this pilot study is to evaluate the feasibility and safety of four different types of intradialytic exercise (exercise performed during dialysis) programs: resistance, aerobic, combined resistance and aerobic, and flexibility (attention control). The secondary aim of the study is to estimate the effect of aerobic and resistance exercise, each compared with the attention control on: health-related quality of life, tests of physical performance, strength, and physical activity outside of the dialysis unit. The results of this study will be used to inform the planning of a full-scale efficacy study.
Detailed description
Recruitment: participants will be recruited by a study coordinator during their regular hemodialysis shift. This is a quaternary outpatient dialysis unit serving approximately 110 patients.
Randomization and allocation: we will use a permuted block design with randomly varied block sizes of eight and twelve. The randomization sequence will be computer generated and randomization to one of the 4 groups will be on a 1:1:1:1 ratio. Allocation is concealed in serially numbered, opaque, sealed envelopes.
Data collection: demographic data, length of time of hemodialysis, cause of ESRD, access type, comorbidities, number of medications, functional status, comorbidities, and dialysis prescription will be collected. The laboratory values and dialysis prescription will be collected from the dialysis unit chart using the most recent monthly blood-work and from the provincial laboratory repository. The amount and intensity of exercise that was performed as well as the participant's heart rate and blood pressure during the exercise session will be recorded at each exercise session. The exercise forms from each participant's dialysis session will be reviewed weekly for missing data. Forms with any empty field will be classified as incomplete and where possible, the appropriate staff will be asked to verify the query.
The occurrence of adverse events will be collected from all four randomization groups.The hemodialysis run-sheet, nursing notes, and exercise data collection form will be reviewed weekly for the occurence of adverse events. Hemodialysis unit staff and the exercise trainer have been instructed to report adverse events (defined a priori) as they occur. In addition, prior to each exercise session, participants will be asked if they have had any new health problems or symptoms since their last exercise session.
Missing data: conditional on the participant's consent, outcome data will be collected from all participants who drop out. For those participants who do not wish to be followed or who have missing data, baseline data will be carried forward.
Safety: due to the short duration and small size of this study, a formal safety and trial management board will not be established. A nephrologist who is not affiliated with the study will review all SAEs as they occur. The nephrologist will then determine if the SAE was associated with the intervention and whether the individual's participation requires modification or discontinuation.
Statistical analysis plan: descriptive statistics will be used to compare the clinical characteristics of the four groups at baseline. All analyses will follow the intention to treat principle.
Safety: in a primary analysis, adverse events will be reported as the number of events directly related to the intervention compared to control, by randomization group. In a secondary analysis, all adverse events that occurred during the study will be analyzed. The frequency of events will be compared using ANOVA or Kruskal-Wallis where appropriate, and with appropriate post-hoc tests to detect differences between randomization groups.
To explore the effect of aerobic and resistance exercise on components of HRQOL we will estimate the absolute change in score at 12 weeks relative to baseline in the physical component summary score (PCS), the mental component summary score (MCS), and the kidney-disease specific score (KDCS). We will report the absolute change in sub-scores for each of the component summary scores. We will use the same method to estimate the difference in scores on the tests of physical performance and strength. Assuming there is no statistical interaction (no indication in the literature), we will estimate the efficacy of the aerobic intervention by comparing all participants who received aerobic exercise with all groups that did not (aerobic and combined exercise groups versus resistance and control exercise groups) and similarly for the resistance-training group. Final scores will be compared using analysis of covariance (ANCOVA) adjusting for the baseline scores and both main effect terms. The final score will be presented as the adjusted difference in the means. To correct for multiple comparisons in the combined exercise group, based on the Bonferroni procedure a significance level of less than 0.025 will be considered significant. The same method will be used to analyze differences in the tests of physical functioning and strength. The interaction will be estimated in a secondary analysis. Due to the small sample size, no subgroup analysis will be performed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Behavioral: ExerciseCycling-participants will exercise for 15 minutes at the initial session followed by a weekly increase of 2 min and 3 seconds over 12 weeks. Participants will exercise 3 times per week and an intensity of "somewhat hard" (12-14 on the Borg scale). All exercises will be performed during hemodialysis. |
| Resistance | Experimental | Behavioral: ExerciseResistance training of lower limbs using ankle weights. Participants will complete 10-15 repetitions of 4 lower limb exercises: knee extension, straight leg raise, hip abduction, and hip flexion. Exercises will progress from 1 set of each exercise up to 3 sets of each exercise and with weight. Participants will exercise 3 times per week and an intensity of "somewhat hard" (12-14 on the Borg scale). All exercises will be performed during hemodialysis. |
| Combined aerobic and resistance | Experimental | Behavioral: ExerciseParticipants will complete both the aerobic (cycling) and resistance (ankle weights) exercise prescriptions. |
| Flexibility | Active comparator | Behavioral: ExerciseA non-progressive flexibility regimen using a stretch band. Participants will perform 2 sets of the following exercises: seated pelvic tilt, seated calf stretch, supine hamstring stretch, and supine gluteal stretch. Participants will exercise 3 times per week and an intensity of "very light" (9 on the Borg scale). All exercises will be performed during hemodialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adult (age ≥18)
- dialysis dependent for ≥ 3 consecutive months
- receiving ≥ 3 dialysis treatments per week
- mobile (any distance and can be with the assistance of an aid)
- at least one non-prosthetic and functional limb
Key exclusion criteria (6 listed)
- currently enrolled in a clinical trial
- missing an average of more than 2 shifts per month
- planned move or modality change within the next 4 months
- currently enrolled in a structured exercise program
- scheduled hospitalization for > 1 week
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: Monark ergometers, TherapyTrainer ergometers, TheraBand Stretch Strap, The Cuff ankle weightsEach exercise will be performed during the first 2.5 hours of the participant's hemodialysis session. Exercises are semi supervised: the kinesiologist will supervise the initial three exercise sessions, any session that requires a change to the exercise prescription and on a minimum of a weekly basis. | Behavioural | Aerobic exercise, Combined aerobic and resistance, Flexibility, Resistance |
Primary outcome
The number of participants with an adverse event
Time frame: Change from baseline to 12 weeks
among each of the intervention groups, the number of participants with and type of adverse events will be compared to control. Adverse events are defined a priori and classified as either i. Serious adverse events (cardiac event e.g. arrhythmia, myocardial infarction; death; hospitalization; disability; any life threatening event) or ii. Adverse events (musculoskeletal injury; hypoglycemia; hypotension, defined as a decrease in systolic blood pressure by ≥20 mm Hg with symptoms or requiring an intervention during exercise; hypertension, define as a sustained elevation in blood pressure of >200 mmHg systolic or >110 diastolic; dialysis access complications (e.g. re-needling, hematosis, thrombosis); and any staff intervention beyond minimum ultrafiltration.
Adherence to the exercise protocol
Time frame: At 12 weeks
To indicate the willingness of participants to engage in intradialytic exercise, adherence will be reported as the proportion of exercise sessions that were initiated out of the total number of sessions prescribed (defined as ≥ 70% of exercise sessions). To measure the amount of exercise that was actually performed, adherence will be defined as the number of sessions that were completed out of the total number of sessions prescribed (defined as ≥ 70% of exercise sessions). Adherence will be reported according to randomization groups.
The number of dropouts
Time frame: At the end of the study, 6 months
A dropout is defined as a participant who leaves the study for any reason prior to completing the 12-week (36 session) exercise program. All reasons for drop out will be reported.
Human activity profile
Time frame: Change from baseline to 12 weeks
To evaluate if an exercise program would influence the level of daily physical activity in this population, the difference in the amount of daily physical activity performed outside of the HD unit at baseline and at 12 weeks will be measured.
The number of participants who adopted the other group's exercise
Time frame: Change from baseline and 12 weeks
Due the open nature of the dialysis unit, participants are aware of other participant's exercise assignments. To measure the effect of contamination, we will obtain this information from participants at the end of the study through an anonymized questionnaire.
The proportion of patients that would continue their current intradialytic exercise program after the study is over.
Time frame: At the end of the study, 6 months.
Defined as ≥50% of participants reporting that they would like to continue their current intradialytic exercise program after the study is over. This information will be collected at the end of the study using an anonymized questionnaire
5 secondary outcomes
Health-related quality of life
Time frame: Change from baseline to 12 weeks
Physical performance
Time frame: Change from baseline to 12 weeks
The six minute walk test
Time frame: Change from baseline to 12 weeks
Number of chair stands completed in 30 seconds
Time frame: Change from baseline to 12 weeks
Strength, one repetition maximum
Time frame: Change from baseline to 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 19 Jul 2022.
- Results publication: PubMed 27601500Thompson S, Klarenbach S, Molzahn A, Lloyd A, Gabrys I, Haykowsky M, Tonelli M. Randomised factorial mixed method pilot study of aerobic and resistance exercise in haemodialysis patients: DIALY-SIZE! BMJ Open. 2016 Sep 6;6(9):e012085. doi: 10.1136/bmjopen-2016-012085.
- 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.
Stephanie Thompson, MD principal investigator
University of Alberta
Scott Klarenbach, MD principal investigator
University of Alberta
Marcello Tonelli, MD 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 Renal Disease, run by University of Alberta 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 7 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: finished, as of the sponsor's last update on 19 Jul 2022. 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?
The number of participants with an adverse event (time frame: Change from baseline to 12 weeks). The study lists 6 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 NCT02234232, which also lists 2 linked publications.
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 19 Jul 2022.