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Trial registered on ANZCTR
Registration number
ACTRN12608000605392
Ethics application status
Not yet submitted
Date submitted
16/11/2008
Date registered
3/12/2008
Date last updated
3/12/2008
Type of registration
Prospectively registered
Titles & IDs
Public title
A phase 1 trial of exercise for patients admitted to hospital with acute exacerbation of chronic obstructive pulmonary disease (COPD)
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Scientific title
A phase 1 trial of exercise for patients admitted to hospital with acute exacerbation of chronic obstructive pulmonary disease (COPD)- the safety and feasibility of exercise programme.
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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:
Acute exacerbation of COPD
4050
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Condition category
Condition code
Respiratory
4256
4256
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0
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention group 1: Routine care (similiar to control group) with the addition of two fifteen minutes exercise session per day from the second day of admission to day of discharge. The exercise programme will include a walking programme and strengthening exercise. Participants in this group will be required to cover 70% of the distance that they achieve during the 3 minute walk test at initial assessment and perform 8-10 repetitions of each of the strengthening exercises.
Intervention group 2: Routine care in addition of identical exercise programme performed in intervention group 1 from second day of admission to day of discharge. However, participants in this group are only required to cover 40% of their distance achieved during their initial three minute walk test and perform 20-25 repetitions of each of the strengthening exercises.
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Intervention code [1]
3772
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Treatment: Other
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Comparator / control treatment
Standard care: Routine medical, nursing and physiotherapy care for patients who presented with an acute exacerbation of COPD. The duration of standard care will occur during their inpatient admission.
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Control group
Active
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Outcomes
Primary outcome [1]
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number of adverse events will be assessed. Events will be classified as an adverse event when the conditions below occur
All adverse events are categorised into adverse physiological incident and adverse physiological changes. Adverse physiological incident refers to an occurrence of one or more adverse physiological changes as a result of one physiotherapy treatment. Examples of adverse physiological incidents include death, acute myocardial infarct, myocarditis, respiratory distress, ventricular arrhythmias, vaso-vagal episodes, collapse and acute musculoskeletal aches and pain. On the other hand, adverse physiological changes refer to change in vital signs during physiotherapy intervention and ten minutes after physiotherapy. The details are as below:
Blood pressure:An alteration in systolic blood pressure > or < 20% of resting value.
Heart rate:>85% of theorized maximum HR calculated by taking 85% of 220- age of patient
Oxygen saturation:Decrease in SpO2 >10% or one which necessitates ceasing treatment (SpO2 <88% on 15lpm or FiO2 of 50%)
Fall that has occurred during the treatment
Systematic signs such as breaking out into cold sweat, complaining of heart palpitations, increasing in rate of respiration to >25 breaths per minute.
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Assessment method [1]
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Timepoint [1]
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Adverse events are assessed during and at the end of each exercise session daily
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Primary outcome [2]
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Change in patient's rating on perceived level of shortness of breath as per the Borg score
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Assessment method [2]
5073
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Timepoint [2]
5073
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Before the commencement of the exercise programme and two minutes post exercise programme each day
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Primary outcome [3]
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Change in vital signs that include oxygen saturation, blood pressure and heart rate as measured by a portable pulse oxymeter and blood pressure cuff
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Assessment method [3]
5074
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Timepoint [3]
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Beginning and two minute post exercise after each exercise session
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Secondary outcome [1]
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Change in distance in 3 minute walk test to measure changes in exercise tolerance
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Assessment method [1]
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Timepoint [1]
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At baseline and on the day of discharge
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Secondary outcome [2]
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Difference in length of stay between three groups by looking at the hospital record regarding number of days of admission
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Assessment method [2]
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Timepoint [2]
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Length of stay will be recorded on the day of discharge
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Secondary outcome [3]
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Number of drop outs as classified as the number of participants who refuse to continue to participate in the exercise programme during their inpatient stay
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Assessment method [3]
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Timepoint [3]
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From second day of admission to day of discharge
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Secondary outcome [4]
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Change in muscle strength of arms and legs as measured by a hand held dynanometer
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Assessment method [4]
8651
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Timepoint [4]
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At baseline and on day of discharge
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Secondary outcome [5]
8652
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Change in lung function in particular minute ventilation and forced expiratory volume in one second as measured by a portable lung spirometry
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Assessment method [5]
8652
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Timepoint [5]
8652
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At baseline and on the day of discharge
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Secondary outcome [6]
8653
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Change in global rate of change scale to measure the changes in patient's perceived change in lung function and symptoms after completion of exercise programme
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Assessment method [6]
8653
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Timepoint [6]
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On the day of discharge
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Secondary outcome [7]
8654
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Change in Barthel index that measures the level of function of patients in terms of ability to transfer and ambulate
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Assessment method [7]
8654
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Timepoint [7]
8654
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At baseline and on the day of discharge
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Eligibility
Key inclusion criteria
1. A primary admission diagnosis of acute exacerbation of COPD, or pneumonia or chest infection with a past medical history of COPD
- All levels of severity will be considered
2. Able to ambulate independently or with minimal assistance of one person with/without a gait aid.
3. Able to obey two-stage commands, obtain a score of 15 on the Glasgow Coma Scale, be orientated to time, day and date and have no previous documented diagnosis of dementia
4. Patients are managed on the general medical wards.
5. Patients that are spontaneously ventilating and do not required any continuous assistance with ventilation.
6. Able to give informed consent to participate in the trial.
7. Must obtain approval of supervising medical officer that patient can participate in trial
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patients who are clinically unstable as defined by below
- Presence of hyperthermia (temperature of =380 Celsius)
- Systolic pressure of <90 or >170mmHg
- Diastolic pressure of >120mmHg
- Unconscious or patients in a delirious state
- Patients with severe respiratory acidosis with a blood pH < 7.3 (McKenzie et al., 2007)
- Patients measured to have an acute cardiac arrhythmia during admission.
- Patients who are tachycardiac with a resting heart rate >120 beats per minute.
2. Patients with other co-morbidities that may impair the ability to participate in an exercise programme (for example severe osteoarthritis, severe neurological conditions with residual deficits, severe low back pain and acute musculoskeletal injuries).
3. Patients who are acutely confused and unable to follow simple instructions.
4. - Patients admitted to the intensive care unit.
- Patients admitted to short stay unit or Rapid Acute Medical Unit (RAMU)
5. Patients that required intubation and mechanical ventilation and/or admitted into intensive care.
6. Patients from a high-level or palliative care facility
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Study design
Purpose of the study
Treatment
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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)
Potential participants will receive usual nursing and medical care on admission into Maroondah Hospital. The nursing unit manager of each ward will refer potential participants to routine ward physiotherapist who is not the principal researcher. The routine ward physiotherapist will ask if potential patients are interested to have more information about the research. The principal researcher will then approach the potential interested patients and will identify if the patient is able to participate in the project.
Upon identification, potential participants will be invited verbally to participate in the project by the principal researcher on the either the 1st or 2nd day of admission. They will be provided with a participant information and consent form. They will also require medical clearance from treating medical unit that participants are suitable to participate in the project and have the capacity to exercise.
Prior to commencement of the recruitment, research investigator (NT) will generate the block sequence. Thirty envelope will be generated using a concealed method. In each envelope, information on group allocation will be included and each participant will be assigned to a number in order of recruitment to the trial. Participants will only be allocated to their group after the assessor has completed baseline assessments. Allocation will be administered by the principal researcher to ensure blinding of the assessor to group allocation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants of this trial will be randomly allocated into one of the three groups (Control(CTRL), 40% exercise programme (EP) and 70% exercise programme (EP)) by applying the block randomisation method (Beller, Gebski, & Keech, 2002).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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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
Safety/efficacy
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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
1/03/2009
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Actual
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Date of last participant enrolment
Anticipated
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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
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Clarice Youci Tang
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Address [1]
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Maroondah Hospital
Davey Drive,
Ringwood East
Vic 3135
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Clarice Youci Tang
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Address
Maroondah Hospital
Davey Drive,
Ringwood East
Vic 3135
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Country
Australia
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Secondary sponsor category [1]
3748
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Individual
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Name [1]
3748
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Professor Nicholas Taylor
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Address [1]
3748
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Education Centre
Peter James Centre
Locked Bag
PO Forest Hill 3131
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Country [1]
3748
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Australia
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Other collaborator category [1]
479
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Individual
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Name [1]
479
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Felicity Blackstock
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Address [1]
479
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La Trobe University
Bundoora Vic 3086
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Country [1]
479
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Australia
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Other collaborator category [2]
480
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Individual
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Name [2]
480
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Dr Michael Clarence
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Address [2]
480
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Maroondah Hospital
Davey Drive,
Ringwood East
Vic 3135
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Country [2]
480
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
6229
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Ethics committee address [1]
6229
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Ethics committee country [1]
6229
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Date submitted for ethics approval [1]
6229
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24/11/2008
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Approval date [1]
6229
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Ethics approval number [1]
6229
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Summary
Brief summary
The effects of the exercise programme in the pulmonary rehabilitation has been thoroughly evaluated on people who are in their stable stage of COPD and the training has been proven to be very beneficial to this population (Lacasse et al.2003, (Nicki et al., 2006), (Carter & Nicotra, 1996; Mink, 1997). Benefits of exercise training include improved sense of well-being, increase in muscle metabolic capacity, reduction in lactic acid and increase in cross section of muscle fibres (Nicki et al., 2006). However, there are no trial investigating the possibility of implementing the exercise programme for patients who have been admitted for acute exacerbation of COPD.
The primary aims of study is to investigate the safety and feasibility of implementing an exercise programme for patients with acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD) and also aim to establish the optimal intensity of exercise for in-patient exercise programme
An estimated number of 30 participants will be recruited and assessed on the 1st or 2nd day following admission with the intention of commencing intervention from 2nd day of admission up to day of discharge. Out of the three groups, one will be the control group that received standard care and the other two will participate in a twice-daily 15 minutes exercise sessions during the trial duration in addition of standard physiotherapy treatment that the control group will be receiving. The two exercise groups will be exercising at either 40% or 70% maximal output intensity.
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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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Address
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Country
29135
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Phone
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Fax
29135
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Email
29135
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Contact person for public queries
Name
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Clarice Youci Tang
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Address
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Maroondah Hospital
Davey Drive,
Ringwood East
Vic 3135
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Country
12292
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Australia
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Phone
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+61 (03) 9871 3502
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Fax
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Email
12292
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[email protected]
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Contact person for scientific queries
Name
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Clarice Youci Tang
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Address
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Maroondah Hospital
Davey Drive,
Ringwood East
Vic 3135
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Country
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Australia
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Phone
3220
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+61 (03) 9871 3502
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Fax
3220
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Email
3220
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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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