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Trial registered on ANZCTR
Registration number
ACTRN12614000557639
Ethics application status
Approved
Date submitted
16/05/2014
Date registered
23/05/2014
Date last updated
24/01/2017
Type of registration
Prospectively registered
Titles & IDs
Public title
Does the speed of aquatic therapy exercises alter arm volume in women with lymphoedema?
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Scientific title
Are slow aquatic therapy exercises better than fast aquatic exercise in decreasing arm volume in women with lymphoedema?
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Secondary ID [1]
284619
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NIL
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Universal Trial Number (UTN)
U1111-1156-9641
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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:
Lymphoedema of the arm
291926
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Condition category
Condition code
Physical Medicine / Rehabilitation
292280
292280
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0
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Physiotherapy
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Cardiovascular
292303
292303
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Slow aquatic therapy (Ai Chi) is an exercise protocol based on the principles of Tai Chi, that uses rhythmic, breathing and movement patterns for the whole body. Research 'subjects' will undertake a single sessions of slow aquatic therapy (Ai Chi) of approximately 50 mins. Subjects will participate within a group (8-10) for slow aquatic exercise. They will be measured pre / post the exercise intervention by a researcher who is "blinded" to their exercise format; Ai Chi (Slow) or Conventional (fast). there is then at least a one-week washout period, after which the subjects will be allocated to other intervention (control) exercise protocol. this will again be in a small group (8-10) and again be measured pre / post by the research assistant who is blind to their randomized Exercise protocol.
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Intervention code [1]
289397
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Rehabilitation
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Comparator / control treatment
the control intervention is a single session of fast aquatic therapy (conventional), for the standard time of approximately 50 mins. It involves fast aerobic and balance exercises followed by a cool down period, i.e. it is the standard exercise class. the research subject will participate in the group (8-10) for the exercises and will also be measured pre / post intervention by the research assistant who is blind to their randomized exercise protocol.
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Control group
Active
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Outcomes
Primary outcome [1]
292142
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Volume of arm measured via water displacement (volumetry)
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Assessment method [1]
292142
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Timepoint [1]
292142
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Immediately after intervention
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Primary outcome [2]
292143
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Body composition of the arm via Impedance
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Assessment method [2]
292143
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Timepoint [2]
292143
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immediately after intervention
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Secondary outcome [1]
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Satisfaction is measured via a questionnaire used previously for this client group with Open ended questions and Likert scale for satisfaction. this has been previously used by this organisation and had ethical approval from the Bendigo Hospital ethics Committee.
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Assessment method [1]
308283
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Timepoint [1]
308283
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On completion of data collection
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Eligibility
Key inclusion criteria
Women with upper limb lymphoedema
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Minimum age
30
Years
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Maximum age
85
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Medically unstable or unfit to undertake aquatic therapy, such as open wounds.
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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)
Participants with arm lymphoedema will be invited to participate via open advertisement. Participants will be allocated to receive Ai Chi treatment in the first session and the comparator treatment at the second session; or comparator treatment first and Ai Chi treatment second. Randomisation will be performed by sealed opaque envelopes and administered by a staff member not involved in the study.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation order will be generated via computer software and administered via a third staff member who is concealed from group allocation.
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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
Crossover
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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
Normality of data will be investigated and if normal then Analysis of Variance 2x2 will be applied. Kruskall-Wallis will be used if data is non parametric. Sample size calculation was performed. Twenty four participants will be recruited for this study considering a calculation of 10% difference in volume between the two exercise protocols. For that, a SD of 10%, power of 0.8, alpha of 0.5 and drop-out rate of 20% were used for calculation.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
26/05/2014
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Actual
7/07/2014
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Date of last participant enrolment
Anticipated
15/12/2014
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Actual
1/02/2016
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Date of last data collection
Anticipated
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Actual
8/02/2016
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Sample size
Target
24
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Accrual to date
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Final
18
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Bendigo Health Care Group - Anne Caudle campus - Bendigo
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Recruitment postcode(s) [1]
8124
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3550 - Bendigo
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Funding & Sponsors
Funding source category [1]
289244
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Hospital
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Name [1]
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Bendigo Health
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Address [1]
289244
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PO Box 126 Bendigo - VIC - 3552
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Country [1]
289244
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Australia
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Primary sponsor type
Hospital
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Name
Bendigo Health
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Address
Bendigo Hospital - Rehabilitation Unit - POBox 126 Bendigo - 3552 - VIC.
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Country
Australia
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Secondary sponsor category [1]
287918
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None
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Name [1]
287918
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Address [1]
287918
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Country [1]
287918
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
291013
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Bendigo Health Expedited Human Research Ethics Committee
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Ethics committee address [1]
291013
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PO Box 126 Bendigo, 3552. VIC.
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Ethics committee country [1]
291013
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Australia
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Date submitted for ethics approval [1]
291013
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30/01/2014
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Approval date [1]
291013
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06/03/2014
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Ethics approval number [1]
291013
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LNR/14/BHCG/6
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Summary
Brief summary
Project aim: to compare the changes in upper limb volume between a low speed aquatic exercise protocol and a conventional aquatic exercise protocol in women with secondary lymphoedema. We anticipate that slow aquatic exercise (Ai Chi) will have a greater reduction in arm volume than fast aquatic exercise.
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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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Mrs Rosalind Deacon
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Address
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Rehabilitation Unit - Bendigo Health
PO Box 126 - Bendigo 3552 VIC.
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Country
48494
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Australia
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Phone
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+61 3 54548789
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Fax
48494
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+61 3 54549113
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Email
48494
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[email protected]
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Contact person for public queries
Name
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Rosalind Deacon
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Address
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Rehabilitation Unit - Bendigo Health
PO Box 126 - Bendigo, 3552 VIC.
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Country
48495
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Australia
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Phone
48495
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+61 3 54548789
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Fax
48495
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+61 3 54549113
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Email
48495
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[email protected]
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Contact person for scientific queries
Name
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Marcos de Noronha
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Address
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La Trobe University Rural Health School
PO Box 199
Bendigo, 3552 VIC.
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Country
48496
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Australia
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Phone
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+61 3 54447231
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Fax
48496
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Email
48496
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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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