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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?
Scientific title
Are slow aquatic therapy exercises better than fast aquatic exercise in decreasing arm volume in women with lymphoedema?
Secondary ID [1] 284619 0
NIL
Universal Trial Number (UTN)
U1111-1156-9641
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoedema of the arm 291926 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292280 292280 0 0
Physiotherapy
Cardiovascular 292303 292303 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 289397 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 292142 0
Volume of arm measured via water displacement (volumetry)
Timepoint [1] 292142 0
Immediately after intervention
Primary outcome [2] 292143 0
Body composition of the arm via Impedance
Timepoint [2] 292143 0
immediately after intervention
Secondary outcome [1] 308283 0
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.
Timepoint [1] 308283 0
On completion of data collection

Eligibility
Key inclusion criteria
Women with upper limb lymphoedema
Minimum age
30 Years
Maximum age
85 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Medically unstable or unfit to undertake aquatic therapy, such as open wounds.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2467 0
Bendigo Health Care Group - Anne Caudle campus - Bendigo
Recruitment postcode(s) [1] 8124 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 289244 0
Hospital
Name [1] 289244 0
Bendigo Health
Address [1] 289244 0
PO Box 126 Bendigo - VIC - 3552
Country [1] 289244 0
Australia
Primary sponsor type
Hospital
Name
Bendigo Health
Address
Bendigo Hospital - Rehabilitation Unit - POBox 126 Bendigo - 3552 - VIC.
Country
Australia
Secondary sponsor category [1] 287918 0
None
Name [1] 287918 0
Address [1] 287918 0
Country [1] 287918 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291013 0
Bendigo Health Expedited Human Research Ethics Committee
Ethics committee address [1] 291013 0
PO Box 126 Bendigo, 3552. VIC.
Ethics committee country [1] 291013 0
Australia
Date submitted for ethics approval [1] 291013 0
30/01/2014
Approval date [1] 291013 0
06/03/2014
Ethics approval number [1] 291013 0
LNR/14/BHCG/6

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48494 0
Mrs Rosalind Deacon
Address 48494 0
Rehabilitation Unit - Bendigo Health
PO Box 126 - Bendigo 3552 VIC.
Country 48494 0
Australia
Phone 48494 0
+61 3 54548789
Fax 48494 0
+61 3 54549113
Email 48494 0
rdeacon@bendigohealth.org.au
Contact person for public queries
Name 48495 0
Mrs Rosalind Deacon
Address 48495 0
Rehabilitation Unit - Bendigo Health
PO Box 126 - Bendigo, 3552 VIC.
Country 48495 0
Australia
Phone 48495 0
+61 3 54548789
Fax 48495 0
+61 3 54549113
Email 48495 0
rdeacon@bendigohealth.org.au
Contact person for scientific queries
Name 48496 0
Dr Marcos de Noronha
Address 48496 0
La Trobe University Rural Health School
PO Box 199
Bendigo, 3552 VIC.
Country 48496 0
Australia
Phone 48496 0
+61 3 54447231
Fax 48496 0
Email 48496 0
m.denoronha@latrobe.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary