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Trial registered on ANZCTR
Registration number
ACTRN12618001069246
Ethics application status
Approved
Date submitted
12/06/2018
Date registered
27/06/2018
Date last updated
27/06/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Pilot evaluation of the effect of an exercise intervention on quality of life for Australians living in residential aged care
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Scientific title
Pilot evaluation of exercise intervention for Australians living in residential aged care
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Secondary ID [1]
292566
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Older Adults Living in Long-Term Care Facilitities
304235
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Falls
308502
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Quality of Life
308503
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Condition category
Condition code
Public Health
303585
303585
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0
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Health promotion/education
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Physical Medicine / Rehabilitation
303586
303586
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention: the exercise program designed to provide optimal stimulus to the cardiorespiratory and neuromuscular systems while maximising safety, compliance, and retention for older Australians living in residential aged care facilities (RACFs).
The exercise program adheres to the recommendations for physical activity for older adults living in RACF released by the International Association of Gerontology and Geriatrics Global Aging Research Network (De Souto Barreto et al 2016). The program involves twice weekly group exercise sessions of 35-45 min duration per session for 12 weeks. The exercise sessions will comprise a combination of aerobic/endurance (bouts of >10min), strength (8-10 exercises, 10-15 repetition), flexibility (10 mins) and balance/coordination activities tailored to each participant’s need and ability. An Accredited Exercise Physiologist will design and run exercise sessions during the study period, monitor fidelity to the program in coordination with an in-house physiotherapist and a research team member. A class session checklist will be used to assess participants' adherence to the program.
Our industry partner for this project is PresCare. PresCare provides care services including residential, in-home community care and chaplaincy and pastoral care in metropolitan and regional areas throughout Queensland. This pilot project will be undertaken at Vela – a 154-bed aged care facility located in Carina, Brisbane. Vela provides care to residents across three separate buildings: a 60 bed facility (block A); a 64 bed facility (block B); and, a 30-bed special care unit for those diagnosed with dementia.
Residents in block A will be offered the exercise program (i.e., intervention group) while residents in block B will receive usual care (i.e., the control group). The usual care group will receive standard care according to activities designed by the PresCare lifestyle team that include daily walks and Tai Chi.
We anticipate recruiting 60 participants to the study – 30 in the intervention group and 30 in the control. The intervention group will be classified according to the functional ability and / or capacity. An estimated 3 subgroups will be established with an average of 10 participants (i.e., 30 in total). Classification according to the functional ability and / or capacity will ensure that each participant’s exercise prescription is designed to provide optimal stimulus to the cardiorespiratory and neuromuscular systems while maximising safety, compliance and retention. Such a strategy will address the acceptability, effectiveness and sustainability of the exercise program.
The project will be officially launched in July 2018 (subject to ethics approval), at Vela, with an information session for Pres Care staff, residents and their families. This session will introduce the research team, project aims, roles, responsibilities, risks and research procedure. Interested participants will be provided with an information sheet. At the completion of the pilot project another information session will be held to provide participants and their families with results of the study.
At the commencement of the study, specific training will be provided to PresCare staff (exercise physiologist, lifestyle team, facility manager and other staff) on all facets of the exercise program from recruitment through to implementation, potential risks and strategies to mitigate these risks. The half-day training session will take place at Vela and will be conducted by Associate Investigator Associate Professor Prue Cormie who is an Accredited Exercise Physiologist with Exercise and Sport Science Australia.
After an initial information session, participants that express an interest in the study will discuss the exercise program with their GP at their next regular scheduled appointment. The GP will be required to determine if interested residents are physically and mentally fit to participate in the program. Residents, who are supported by their GP, will be asked to provide written consent to participate in the program. Prior to commencing the program and following its completion, participants will receive a one-on-one consultation with an accredited exercise physiologist lasting approximately one hour. These consultations will involve screening of health status, initial and progress assessments in order to individualise the exercise prescription to specific needs, physical abilities and personal preferences.
Objective measurements of physical function, resting blood pressure, height, weight, waist and hip circumferences occurs for all participants at pre- and post-program time points. Physical function will be assessed using the 400m walk and repeated chair rise tests and lower time taken to complete the tests representing higher functional performance. as a measure of cardiovascular fitness, peak oxygen consumption (VO2peak) will be estimated from the 400m walk test time and heart rate response. A validated oscillometric device or sphgomamometer will be used to record brachial blood pressure. Circumference measured using an anthropometric tape in accordance to standard protocols. These assessments will be performed in triplicate with the exception of the 400m test. Patient demographic and reported outcomes will be collected with a series of surveys with sound psychometric properties.
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Intervention code [1]
298772
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Prevention
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Intervention code [2]
298794
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Lifestyle
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Comparator / control treatment
Control group: the usual or standard care according to activities designed by the PresCare lifestyle team that include daily walks and Tai Chi.
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Control group
Active
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Outcomes
Primary outcome [1]
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To measure quality of life utilising a sustainable intervention program in aged residential care. The screening instruments which will be utilised are AQoL-8D,
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Assessment method [1]
306163
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Timepoint [1]
306163
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Baseline
3 months post intervention (primary endpoint)
6 months post intervention completion
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Primary outcome [2]
306164
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Any adverse events ( post intervention only) will be reported by the patient and recorded on an an Adverse Events Log. Adverse events to include any muscle strain, falls, pain as a direct result from the exercise intervention.
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Assessment method [2]
306164
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Timepoint [2]
306164
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3 months post intervention (primary endpoint)
6 months post intervention completion
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Secondary outcome [1]
347747
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To measure cost effectiveness of the exercise intervention program. The following cost effectiveness data will be collected: - the cost of delivering the program obtained from notes held by the project manager; - the health care resource usage (admissions to hospital, ED presentations, number of falls) obtained from Prescare records; - Quality adjusted life years (QALYs) using AQoL- 8D instrument
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Assessment method [1]
347747
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Timepoint [1]
347747
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3 months post intervention
6 months post intervention completion
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Secondary outcome [2]
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Sustainability of the intervention - a qualitative measure that will be assessed via focus group discussions with EP, staff members and participants.
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Assessment method [2]
348579
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Timepoint [2]
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3 months post intervention
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Secondary outcome [3]
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Transferability of the intervention to other Prescare sites as well as other RACFs - a qualitative measure that will be assessed via focus group discussions with EP, staff members and participants.
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Assessment method [3]
348621
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Timepoint [3]
348621
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3 months post intervention
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Eligibility
Key inclusion criteria
An Accredited Physiotherapist will determine if interested residents at Prescare Vela Aged Care Facility are physically and mentally fit to participate in the program in conjunction with the GP and the Facility Manager.
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Minimum age
75
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
Key exclusion criteria, persons less than 75 years of age
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
A pilot pragmatic non-randomised controlled trial with alongside economic evaluation
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
13/08/2018
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Actual
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Date of last participant enrolment
Anticipated
13/11/2018
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Actual
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Date of last data collection
Anticipated
19/02/2019
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment postcode(s) [1]
22748
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4152 - Carina Heights
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Funding & Sponsors
Funding source category [1]
297146
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University
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Name [1]
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Central Queensland University
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Address [1]
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School of Health, Medical and Applied Sciences
160 Ann Street, Brisbane Qld 4000
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Country [1]
297146
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Australia
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Primary sponsor type
University
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Name
Central Queensland University
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Address
School of Health, Medical and Applied Sciences
160 Ann Street, Brisbane Qld 4000
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Country
Australia
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Secondary sponsor category [1]
296158
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None
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Name [1]
296158
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Address [1]
296158
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Country [1]
296158
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
298315
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Central Queensland University Human Research Ethics Committee
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Ethics committee address [1]
298315
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CQUniversity Australia, Building 32, Bruce Highway
Rockhampton, Queensland 4702
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Ethics committee country [1]
298315
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Australia
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Date submitted for ethics approval [1]
298315
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19/07/2017
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Approval date [1]
298315
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10/04/2018
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Ethics approval number [1]
298315
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0000020697
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Summary
Brief summary
Evidence suggests that levels of physical activity tend to decline in older ages and only one in four people over the age of 75 years and over are classified as sufficiently active against Australian national guidelines for physical activity. Our research aims to 1) develop and implement a sustainable exercise program, utilising the recent international recommendations for physical activity for older adults for Australians living in in residential aged care facilities to address physical and psychosocial problems proven to be amenable to exercise; 2) evaluate the acceptability, effectiveness (including cost-effectiveness), sustainability and transferability of the exercise program; and, 3) use the pilot results to develop an application for a NHRMC partnership project. Experimental research design will be used to achieve these aims. This study is a pilot pragmatic non-randomised controlled trial with alongside economic evaluation. Evaluation data will be collected using pre-/post intervention with a comparison group.
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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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Dr Irina Kinchin
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Address
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School of Health, Medical and Applied Sciences CQUniversity
Room 4.18 / WS 11, 160 Ann Street, Brisbane Qld 4000
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Country
76686
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Australia
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Phone
76686
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P +61 7 302 34114 | M +61 410 140 252
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Fax
76686
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61 7 30254114
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Email
76686
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[email protected]
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Contact person for public queries
Name
76687
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Ms Laura Adams
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Address
76687
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School of Health, Medical and Applied Sciences CQUniversity
Room 4.18 / WS 11, 160 Ann Street, Brisbane Qld 4000
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Country
76687
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Australia
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Phone
76687
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P +61 7 302 34114 | M +61 402990508
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Fax
76687
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61 7 30254114
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Email
76687
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[email protected]
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Contact person for scientific queries
Name
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Dr Irina Kinchin
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Address
76688
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School of Health, Medical and Applied Sciences CQUniversity
Room 4.18 / WS 11, 160 Ann Street, Brisbane Qld 4000
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Country
76688
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Australia
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Phone
76688
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P +61 7 302 34114 | M +61 410 140 252
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Fax
76688
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61 7 30254114
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Email
76688
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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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