Osteoporotic FracturesB3ENCT01761084
Build Better Bones With Exercise
A study testing Exercise and behaviour change strategies in people with Osteoporotic Fractures and Spinal Fractures, run by University of Waterloo at 1 site in Canada.
Trial summary
The long-term goal of our research team is to conduct a large multicentre study to evaluate whether tailored home exercise can prevent fractures in high-risk individuals. The proposed project will address the feasibility of such a trial, but will also evaluate the effect of exercise on quality of life, posture and… Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Osteoporotic Fractures, Spinal Fractures
- What is being tested?
- Exercise and behaviour change strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Has a) a known or suspected vertebral fracture of non-traumatic etiology OR b) one of the following:
- documented height loss of ≥2cm
- historical height loss of ≥6cm
- visible hyperkyphosis
- age greater than or equal to 65 years of age
- able to understand instructions in english
- able to give informed consent (no cognitive impairment)
Who cannot join
- Current or prior cancer
- On dialysis, known liver, kidney or malabsorption disease
- Progressive neurological disorder, unable to stand or walk for 10 metres, with/without gait aid or progressive disorder likely to prevent study completion, palliative care.
- Current participation in muscle strengthening or similar exercise program ≥ 3 times per week
- Uncontrolled hypertension or other contraindications to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Build Better Bones With Exercise: A Pilot Randomized Controlled Trial of Exercise in Women With Osteoporotic Vertebral Fracture
The long-term goal of our research team is to conduct a large multicentre study to evaluate whether tailored home exercise can prevent fractures in high-risk individuals. The proposed project will address the feasibility of such a trial, but will also evaluate the effect of exercise on quality of life, posture and many other outcomes important to individuals with vertebral fractures. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. The purpose of this pilot study is determining the feasibility of recruitment, retention and adherence of an international multicentre randomized controlled study evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. As secondary objectives, the investigators will examine the effects of exercise on function, balance, quality of life, pain, falls and fractures. The primary hypothesis is that the investigators will successfully recruit and retain the target sample, and achieve an adherence rate of 60%.
Read the detailed description
There is limited data available from which to develop guidelines for safe and effective exercise prescription among individuals with hip or vertebral fractures. The long-term goal of our research team is to conduct a large multi-centre randomized controlled trial (RCT) to investigate whether participating in a thrice-weekly home exercise program for one year can reduce incident fragility fractures among women aged 65 years or older with a history of vertebral fracture compared to no intervention. The current study is a pilot study with the principal objective of determining the feasibility of recruitment, retention and adherence of an international multicentre RCT evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. The intervention was developed by experts in exercise prescription based on a rigorous literature review and Cochrane meta-analysis we have conducted. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. Secondary outcomes of the pilot study are those hypothesized to be among the causal pathway linking exercise to fracture risk, including lower extremity strength, posture, balance, as well as falls and fractures. Additional secondary outcomes include quality of life, pain, exercise self-efficacy, the cost of the intervention, and the risk of adverse events associated with exercise. The recruitment and retention process will be summarized using a CONSORT flow diagram, and the reporting of results will be in accordance with the CONSORT criteria. Analyses of feasibility objectives will be descriptive or based on estimates with 95% confidence intervals, where feasibility will be assessed relative to criteria defined a priori. Differences in secondary outcomes will be evaluated in intention to treat analyses via independent student T-tests, Chi Square or logistic regression. The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall level is alpha=0.05. Even if the larger trial proves not to be feasible, the current trial will be one of the largest exercise studies among a representative group of women with vertebral fracture to date, and will evaluate the feasibility and costs of a comprehensive home exercise program, and its effect on important secondary outcomes. Osteoporosis Canada has defined a need to develop patient resources on exercise and recently announced a shift in priority to individuals with existing fractures; the proposed pilot study is timely and will directly inform these knowledge translation initiatives.
- Conditions
- Osteoporotic Fractures, Spinal Fractures
- Being tested
- Exercise and behaviour change strategies
- Keywords
- Osteoporosis, Spine fracture, Vertebral fracture, Exercise Interventions, Exercise
- Medical subject headings
- Osteoporotic Fractures, Spinal Fractures, Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and behaviour change strategiesBehavioural
- cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day
- postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily)
- perform muscle strengthening and balance training exercises ≥ 3 days a week
- the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and behaviour change strategies | Experimental | The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing. Receives: Behavioral: Exercise and behaviour change strategies |
| General health or social discussion | No intervention | Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment and Retention
Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained.
Measured: Monthly records up to 12 months.
Adherence
Number of exercise sessions completed relative to prescribed. We will use a diary for participants to self-report adherence.
Measured: Monthly records over 12 months
Secondary outcomes (22)
Number of Fractures.
Incident fracture will be a composite outcome of a vertebral fracture or fragility fracture (excluding fractures due to trauma or cancer). A fracture questionnaire will be used to ascertain the occurrence of fractures, the approximate timing and the cause with fracture occurrence, location and severity verified through health record data. Lateral thoracic and lumbar spine x-rays will be performed on participants at baseline (to confirm prevalent vertebral fractures) and follow-up (to identify new fractures). Vertebral fractures will be defined as radiographic presence of ≥25% reduction in anterior, middle or posterior height of a vertebra using the Genant visual semi-quantitative method.
Measured: Baseline, one year and at report of fracture (monitored monthly for reports).
Number of Fallers
Diary for participants to self-report falls.
Measured: Monthly up to one year.
Occiput to Wall Distance
Measured: Baseline and one year.
Scores on the Short Physical Performance Battery (SPPB)
The SPPB consists of balance tests (side-by-side, semi-tandem, and tandem standing), gait speed during 4-meter walk test, and the average time taken to rise from a chair with arms folded across chest and sit back down (Five-Times-Sit-to-Stand test), sub-scores of which are added to determine a composite score (0-12), with higher scores indicative of better performance.
Measured: Baseline and one year.
Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER).
Balance Outcome Measure for Elder Rehabilitation (BOOMER) includes the step test, the Timed Up and Go, the Functional Reach test and the timed static stance feet together eyes closed test. The sub-scores of which are added to create a composite score (0-16), with higher scores indicating better performance.
Measured: Baseline and one year.
Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS).
OQLQ scores range 1-7, with higher scores indicate greater quality of life. EQ5D5L VAS scores range 0-100, with higher scores indicating better overall health. VAS pain scores range 0-10, with lower scores indicating less pain.
Measured: Baseline, 6 months and one year.
Scores on Exercise Self-efficacy Scales.
To assess self-efficacy related to engaging in exercise, participants will be asked "Over the next 3 months, how confident are you that you can perform exercise on most days of the week?" and "Over the next 3 months, how confident are you that you can perform exercise on 3 days of the week?." To assess implementation intentions, participants are asked "Do you already have concrete plans regarding exercise?". Patients will rate their answers on a scale from 1-5. Higher scores indicate greater exercise self-efficacy.
Measured: Baseline, 6 months and one year.
Score on Short-form Falls Efficacy Scale International (FES-I).
Questionnaire about how concerned the participant is about the possibility of falling during common daily activities. Scores range from 7 (no concern about falling) to 28 (severe concern about falling.
Measured: Baseline, 6 months and one year.
Productivity
Questionnaire regarding much did the participant's spine fracture(s) or osteoporosis affect their productivity while working? The scale is 0-10, with higher numbers indicating more effect on their work.
Measured: Monthly up to one year.
Physical Activity
A modified version of the Short-Form International Physical Activity Questionnaire (IPAQ) will be completed. A subset of participants at the University of Waterloo (St. Mary's General Hospital) will wear an accelerometer for 7 days.
Measured: Baseline, 6 months, 12 months
Number of Serious Adverse Events.
Defined as death or event that is life-threatening, requires hospitalization or results in disability.
Measured: Monthly up to one year.
Number of Individuals Screened and Eligible Per Collection Site.
Number of participants randomized out of all participants screened
Measured: over the course of the study (2.29 years)
Number of Potentially Eligible Males
Measured: over recruitment period
Number of Participants With Multiple Falls
Measured: Monthly up to 12 months.
Total Number of Falls
Measured: Monthly up to 12 months.
Value of Direct Medical Resources Per Participant.
Measured: Accrued costs over 12 months
Value of Non-direct Medical Resources Per Participant.
Measured: Accrued costs over 12 months
Participant Height
Measured: Baseline and one year
Activities of Daily Living
0-10 scale about ability to do activities of daily living. Higher scores indicate more difficulty.
Measured: Monthly up to one year
Timed Loaded Standing Test
A physical performance measure of combined trunk and arm endurance.
Measured: Baseline and one year
Location of Vertebral Fractures
Any vertebral fracture (Genant Grade 1 or higher) found on x-ray, divided into location groupings of T1-T3, T4-T8, T9-L1, and L2-L5.
Measured: Baseline and Month 12
Participant Weight
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoporotic FracturesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Western Ontario, Canada, University Health Network, Toronto, McMaster University, University of Melbourne, University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Lora Giangregorio, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761084
- Sponsor's protocol ID
- 18539
- Acronym
- B3E
- Status last verified
- Mar 2017
- First submitted
- 2 Jan 2013
- Last updated
- 14 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gibbs JC, McArthur C, Wark JD, Thabane L, Scherer SC, Prasad S, Papaioannou A, Mittmann N, Laprade J, Kim S, Khan A, Kendler DL, Hill KD, Cheung AM, Bleakney R, Ashe MC, Adachi JD, Giangregorio LM. The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial. Phys Ther. 2020 Apr 17;100(4):662-676. doi: 10.1093/ptj/pzz188.
PubMed 31899499Giangregorio LM, Thabane L, Adachi JD, Ashe MC, Bleakney RR, Braun EA, Cheung AM, Fraser LA, Gibbs JC, Hill KD, Hodsman AB, Kendler DL, Mittmann N, Prasad S, Scherer SC, Wark JD, Papaioannou A. Build better bones with exercise: protocol for a feasibility study of a multicenter randomized controlled trial of 12 months of home exercise in women with a vertebral fracture. Phys Ther. 2014 Sep;94(9):1337-52. doi: 10.2522/ptj.20130625. Epub 2014 May 1.
PubMed 24786946
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Build Better Bones With Exercise: A Pilot Randomized Controlled Trial of Exercise in Women With Osteoporotic Vertebral Fracture
- ClinicalTrials.gov ID
- NCT01761084
- Acronym / sponsor ID
- B3E / 18539
- Conditions
- Osteoporotic Fractures, Spinal Fractures
- Keywords
- Osteoporosis, Spine fracture, Vertebral fracture, Exercise Interventions, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Western Ontario, Canada, University Health Network, Toronto, McMaster University, University of Melbourne, University of British Columbia
- Study start
- Jan 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Posted 14 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-term goal of our research team is to conduct a large multicentre study to evaluate whether tailored home exercise can prevent fractures in high-risk individuals. The proposed project will address the feasibility of such a trial, but will also evaluate the effect of exercise on quality of life, posture and many other outcomes important to individuals with vertebral fractures. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. The purpose of this pilot study is determining the feasibility of recruitment, retention and adherence of an international multicentre randomized controlled study evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. As secondary objectives, the investigators will examine the effects of exercise on function, balance, quality of life, pain, falls and fractures. The primary hypothesis is that the investigators will successfully recruit and retain the target sample, and achieve an adherence rate of 60%.
Detailed description
There is limited data available from which to develop guidelines for safe and effective exercise prescription among individuals with hip or vertebral fractures. The long-term goal of our research team is to conduct a large multi-centre randomized controlled trial (RCT) to investigate whether participating in a thrice-weekly home exercise program for one year can reduce incident fragility fractures among women aged 65 years or older with a history of vertebral fracture compared to no intervention. The current study is a pilot study with the principal objective of determining the feasibility of recruitment, retention and adherence of an international multicentre RCT evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. The intervention was developed by experts in exercise prescription based on a rigorous literature review and Cochrane meta-analysis we have conducted. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. Secondary outcomes of the pilot study are those hypothesized to be among the causal pathway linking exercise to fracture risk, including lower extremity strength, posture, balance, as well as falls and fractures. Additional secondary outcomes include quality of life, pain, exercise self-efficacy, the cost of the intervention, and the risk of adverse events associated with exercise. The recruitment and retention process will be summarized using a CONSORT flow diagram, and the reporting of results will be in accordance with the CONSORT criteria. Analyses of feasibility objectives will be descriptive or based on estimates with 95% confidence intervals, where feasibility will be assessed relative to criteria defined a priori. Differences in secondary outcomes will be evaluated in intention to treat analyses via independent student T-tests, Chi Square or logistic regression. The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall level is alpha=0.05. Even if the larger trial proves not to be feasible, the current trial will be one of the largest exercise studies among a representative group of women with vertebral fracture to date, and will evaluate the feasibility and costs of a comprehensive home exercise program, and its effect on important secondary outcomes. Osteoporosis Canada has defined a need to develop patient resources on exercise and recently announced a shift in priority to individuals with existing fractures; the proposed pilot study is timely and will directly inform these knowledge translation initiatives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and behaviour change strategies | Experimental | Behavioral: Exercise and behaviour change strategiesThe exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing. |
| General health or social discussion | No intervention | –Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Has a) a known or suspected vertebral fracture of non-traumatic etiology OR b) one of the following:
- age greater than or equal to 65 years of age
- able to understand instructions in english
- able to give informed consent (no cognitive impairment)
Key exclusion criteria (5 listed)
- Current or prior cancer
- On dialysis, known liver, kidney or malabsorption disease
- Progressive neurological disorder, unable to stand or walk for 10 metres, with/without gait aid or progressive disorder likely to prevent study completion, palliative care.
- Current participation in muscle strengthening or similar exercise program ≥ 3 times per week
- Uncontrolled hypertension or other contraindications to 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 |
|---|---|---|
| Exercise and behaviour change strategies1. cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day 2. postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) 3. perform muscle strengthening and balance training exercises ≥ 3 days a week 4. the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day. | Behavioural | Exercise and behaviour change strategies |
Primary outcome
Feasibility of Recruitment and Retention
Time frame: Monthly records up to 12 months.
Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained.
Adherence
Time frame: Monthly records over 12 months
Number of exercise sessions completed relative to prescribed. We will use a diary for participants to self-report adherence.
22 secondary outcomes
Number of Fractures.
Time frame: Baseline, one year and at report of fracture (monitored monthly for reports).
Number of Fallers
Time frame: Monthly up to one year.
Occiput to Wall Distance
Time frame: Baseline and one year.
Scores on the Short Physical Performance Battery (SPPB)
Time frame: Baseline and one year.
Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER).
Time frame: Baseline and one year.
Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS).
Time frame: Baseline, 6 months and one year.
Scores on Exercise Self-efficacy Scales.
Time frame: Baseline, 6 months and one year.
Score on Short-form Falls Efficacy Scale International (FES-I).
Time frame: Baseline, 6 months and one year.
Productivity
Time frame: Monthly up to one year.
Physical Activity
Time frame: Baseline, 6 months, 12 months
Number of Serious Adverse Events.
Time frame: Monthly up to one year.
Number of Individuals Screened and Eligible Per Collection Site.
Time frame: over the course of the study (2.29 years)
Number of Potentially Eligible Males
Time frame: over recruitment period
Number of Participants With Multiple Falls
Time frame: Monthly up to 12 months.
Total Number of Falls
Time frame: Monthly up to 12 months.
Value of Direct Medical Resources Per Participant.
Time frame: Accrued costs over 12 months
Value of Non-direct Medical Resources Per Participant.
Time frame: Accrued costs over 12 months
Participant Height
Time frame: Baseline and one year
Activities of Daily Living
Time frame: Monthly up to one year
Timed Loaded Standing Test
Time frame: Baseline and one year
Location of Vertebral Fractures
Time frame: Baseline and Month 12
Participant Weight
Time frame: Baseline and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31899499Gibbs JC, McArthur C, Wark JD, Thabane L, Scherer SC, Prasad S, Papaioannou A, Mittmann N, Laprade J, Kim S, Khan A, Kendler DL, Hill KD, Cheung AM, Bleakney R, Ashe MC, Adachi JD, Giangregorio LM. The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial. Phys Ther. 2020 Apr 17;100(4):662-676. doi: 10.1093/ptj/pzz188.
- Derived from this study: PubMed 24786946Giangregorio LM, Thabane L, Adachi JD, Ashe MC, Bleakney RR, Braun EA, Cheung AM, Fraser LA, Gibbs JC, Hill KD, Hodsman AB, Kendler DL, Mittmann N, Prasad S, Scherer SC, Wark JD, Papaioannou A. Build better bones with exercise: protocol for a feasibility study of a multicenter randomized controlled trial of 12 months of home exercise in women with a vertebral fracture. Phys Ther. 2014 Sep;94(9):1337-52. doi: 10.2522/ptj.20130625. Epub 2014 May 1.
- Principal InvestigatorLink provided by the sponsor.
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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.
Lora Giangregorio, PhD principal investigator
University of Waterloo
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 and behaviour change strategies in people with Osteoporotic Fractures and Spinal Fractures, run by University of Waterloo 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 5 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 14 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 14 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Recruitment and Retention (time frame: Monthly records up to 12 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 NCT01761084, 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 14 Nov 2019; AzTrials last refreshed its copy on 27 Oct 2026.