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Trial registered on ANZCTR
Registration number
ACTRN12619001183178
Ethics application status
Approved
Date submitted
5/08/2019
Date registered
22/08/2019
Date last updated
11/02/2021
Date data sharing statement initially provided
22/08/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Preventing falls in older age with yoga-based exercise: effectiveness, cost-effectiveness and implementation
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Scientific title
What is the effect of a group-based yoga exercise program compared to a yoga relaxation program on falls among community-dwelling people aged 60 years and over?
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Secondary ID [1]
298827
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APP1163067
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Universal Trial Number (UTN)
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Trial acronym
Successful AGEing (SAGE) yoga trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Falls
313782
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Condition category
Condition code
Injuries and Accidents
312184
312184
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm 1: Group-based yoga exercise program
Participants allocated to the group-based yoga exercise program will be offered attendance at either face-to-face yoga classes at established yoga studios or online group-based yoga classes delivered by Zoom, in trial-specific groups of 10-20 people with experienced yoga teachers. Participants accessing the classes online will also be offered participation in a class-specific WhatsApp group to promote social connection between class members. Participants will aim to attend 80, one-hour duration classes in total on a twice-weekly basis, over the 12-month period. Participants will be also asked to complete an unsupervised yoga program for at least two 20-minute sessions each week.
The yoga classes will be provided free of charge to participants. Class content will emphasise standing yoga postures that challenge balance and build leg strength. The program will be tailored to participant ability and progression of difficulty for each posture will occur as skills and confidence increase. The program is based on the Iyengar style of yoga which was chosen as it involves holding static postures rather than flowing movements, which is likely to be simpler to learn and has been used successfully with older adults. Iyengar yoga also uses aids (“props” e.g. blocks, straps) to modify the postures and to enable people with a range of functional abilities to participate, making it the ideal style for older people. Intervention adherence will be recorded by yoga teachers who will keep class attendance records and participants who will keep home yoga practise diaries.
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Intervention code [1]
315093
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Treatment: Other
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Intervention code [2]
315094
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Prevention
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Comparator / control treatment
Arm 2: Yoga relaxation program group
Participants allocated to the yoga relaxation program group will attend two one-hour workshops with groups of 10-20 people to learn a relaxation yoga program. Participants will be encouraged to practice this regularly. Participants will be able to attend either face-to-face or online workshops. The workshops will be held at approximately 2 weeks and 6 weeks after randomisation. The frequency of practice of the yoga relaxation program will be at the discretion of the participants. The yoga relaxation program differs from the intervention in that it will include seated or lying postures that do not impact on balance or leg strength but emphasise breathing and relaxation
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Control group
Active
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Outcomes
Primary outcome [1]
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Number of falls in the 12 months after randomisation, assessed using monthly falls calendars.
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Assessment method [1]
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Timepoint [1]
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12 month period after randomisation.
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Secondary outcome [1]
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Mental wellbeing assessed using the Warwick-Edinburgh Mental Well-being Scale.
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Assessment method [1]
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Timepoint [1]
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Baseline and 12 months after randomisation
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Secondary outcome [2]
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Self-reported overall physical activity, planned activity and home exercise assessed with the Incidental and Planned Exercise Questionnaire.
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Assessment method [2]
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Timepoint [2]
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Baseline and 12 months after randomisation
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Secondary outcome [3]
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Quality of life assessed using the EQ-5D-5L.
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Assessment method [3]
372943
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Timepoint [3]
372943
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Baseline and 12 months after randomisation
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Secondary outcome [4]
372944
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Balance self-confidence assessed with the Activity-specific Balance Confidence Scale- Simplified
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Assessment method [4]
372944
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Timepoint [4]
372944
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Baseline and 12 months after randomisation
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Secondary outcome [5]
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Physical function assessed with the lower limb function subscale of the Late Life Function and Disability Instrument.
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Assessment method [5]
372945
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Timepoint [5]
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Baseline and 12 months after randomisation
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Secondary outcome [6]
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Pain assessed with specific study developed questions
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Assessment method [6]
372946
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Timepoint [6]
372946
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Baseline and 12 months after randomisation
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Secondary outcome [7]
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Goal attainment measured with the Goal Attainment Scale.
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Assessment method [7]
372947
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Timepoint [7]
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12 months after randomisation
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Secondary outcome [8]
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Sleep quality and disturbances measured using Pittsburg Sleep Quality Index.
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Assessment method [8]
372948
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Timepoint [8]
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Baseline and 12 months after randomisation
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Secondary outcome [9]
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Cost-effectiveness of delivering the intervention, fall-related and total costs of health and community service utilisation. Health-system and community-service contact will be collected on a monthly basis along with the falls calendars. Participants will be asked to mark on the monthly postal questionnaire each time they use a health and community service (e.g. GP, physiotherapist, nurse).
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Assessment method [9]
373945
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Timepoint [9]
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12-month period after randomisation.
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Secondary outcome [10]
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Process evaluation using semi-structured interviews with yoga instructors and participants.
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Assessment method [10]
373946
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Timepoint [10]
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12 and 18 months after randomisation.
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Eligibility
Key inclusion criteria
Eligible participants will:
a) Be aged 60 years and over;
b) Live independently at home;
c) Not currently participate in yoga;
d) Be able to attend the yoga classes either online or in person
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
People will be excluded if they:
a) Are “house-bound” (have not been outside independently in past month);
b) Have a cognitive impairment (scoring 4 or less on the 8-point Memory Impairment Screen);
c) Have insufficient English language skills to fully participate;
d) Have self-assessed inability to walk 10 metres unassisted; have a progressive neurological disease (e.g. Parkinson‘s disease);
e) Have a medical condition precluding exercise (e.g. unstable cardiac disease).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation will be determined using REDCap (Research Electronic Data Capture), a centralised web-based randomisation system within The University of Sydney. This will ensure concealment of allocation to groups and an auditable process. Randomisation will occur after participants have completed all baseline measures to avoid recruitment bias.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be created by a researcher not involved in recruitment/eligibility assessment using Stata software (StataCorp) and embedded in the study REDCap database. The group allocation system will use stratification to ensure balance by yoga studio location.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The number of falls per person-year will be analysed using negative binomial regression models to estimate between-group difference in fall rates after one year (primary outcome). Generalised linear models will assess the effect of group allocation on continuously-scored secondary outcomes (mental wellbeing, physical activity, quality of life, balance confidence, physical function, pain, goal attainment, sleep), adjusting for baseline scores. Analyses will follow a pre-specified Statistical Analysis Plan, will be conducted while masked to group allocation and will use an intention-to-treat approach. Analyses will utilise Stata software and will be overseen by an experienced biostatistician.
The economic evaluation will take a health and community care funder perspective, and will include benefits related to falls prevented and Quality Adjusted Life Years (QALY) gained. Using mean costs and mean health outcomes in each trial arm, the incremental cost/ QALY of the intervention group compared with control group will be calculated and plotted on a cost-effectiveness plane. Bootstrapping will be used to estimate a distribution around costs and health outcomes, and to calculate the confidence intervals around the incremental cost-effectiveness ratios. One-way sensitivity analysis will be conducted around key variables, and a probabilistic sensitivity analysis will be conducted to estimate the joint uncertainty in all parameters; a cost-effectiveness acceptability curve (CEAC) will be plotted to measure the probability that an intervention is cost-effective, given a decision maker’s willingness to pay for each additional QALY gained. We will collect intervention cost data (staff costs, consumables, capital costs), health and community service contact, fall rates and utility-based quality of life.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/09/2019
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Actual
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Date of last participant enrolment
Anticipated
1/09/2022
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
560
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Accrual to date
0
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
303378
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Government body
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Name [1]
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NHMRC Project Grant
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Address [1]
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Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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Country [1]
303378
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
PO BOX M179
Missenden Road, Camperdown
NSW 2050
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Country
Australia
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Secondary sponsor category [1]
303411
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None
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Name [1]
303411
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Address [1]
303411
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Country [1]
303411
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303910
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The University of Sydney Human Research Ethics Committee
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Ethics committee address [1]
303910
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Human Ethics Office Margaret Telfer Building (K07) University of Sydney NSW 2006
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Ethics committee country [1]
303910
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Australia
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Date submitted for ethics approval [1]
303910
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04/07/2019
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Approval date [1]
303910
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22/08/2019
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Ethics approval number [1]
303910
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Summary
Brief summary
This study aims to compare the effect on falls and other measures of health and wellbeing of: a) a group-based yoga exercise program over 12 months, and b) a seated unsupervised yoga relaxation program over 12 months. Participants allocated to the group-based yoga exercise program will attend either face-to-face yoga classes at established yoga studios with experienced yoga teachers or online classes delivered via Zoom for one hour, twice weekly for 40 weeks. Participants allocated to the yoga relaxation program group will attend two either face-to-face or online one-hour workshops to learn a relaxation yoga program. We hypothesise that greater effects on the rate of falls will be evident from the group-based yoga exercise program compared to the yoga relaxation program.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Anne Tiedemann
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Address
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Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, PO Box M179 Missenden Rd NSW 2050
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Country
95214
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Australia
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Phone
95214
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+61 2 86276233
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Fax
95214
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+61 2 96570301
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Email
95214
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anne.tiedemann@sydney.edu.au
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Contact person for public queries
Name
95215
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Anne Tiedemann
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Address
95215
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Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, PO Box M179 Missenden Rd NSW 2050
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Country
95215
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Australia
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Phone
95215
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+61 2 86276233
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Fax
95215
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+61 2 96570301
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Email
95215
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anne.tiedemann@sydney.edu.au
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Contact person for scientific queries
Name
95216
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Anne Tiedemann
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Address
95216
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Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, PO Box M179 Missenden Rd NSW 2050
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Country
95216
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Australia
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Phone
95216
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+61 2 86276233
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Fax
95216
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+61 2 96570301
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Email
95216
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anne.tiedemann@sydney.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data underlying published results
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When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
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Available to whom?
Data will be available on a case-by-case basis at the discretion of the Principal Chief Investigator.
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Available for what types of analyses?
For meta-analysis.
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How or where can data be obtained?
Access subject to approvals by Principal Chief Investigator (anne.tiedemann@sydney.edu.au)
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
anne.tiedemann@sydney.edu.au
Statistical analysis plan
anne.tiedemann@sydney.edu.au
Informed consent form
anne.tiedemann@sydney.edu.au
Ethical approval
anne.tiedemann@sydney.edu.au
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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