Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000543088
Ethics application status
Approved
Date submitted
24/06/2010
Date registered
6/07/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Yoga Program for Arm Lymphoedema
Scientific title
A Yoga Intervention for breast Cancer Related Lymphoedema - A Preliminary Study
Secondary ID [1] 252095 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer related lymphoedema (BCRL) 257649 0
Condition category
Condition code
Alternative and Complementary Medicine 257821 257821 0 0
Other alternative and complementary medicine
Cardiovascular 257822 257822 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cancer 257854 257854 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All particiapnats will attend a single self managment seminar prior to commencement of the intervention. Self management for BCRL includes simplified self massage, exercise, the use of compression and appropriate skin care.
The intervention group will also attend Yoga classes. Yoga practice including adapted physical postures, guided relaxation and meditation delivered as 4 X weekly group classes of 90 minutes duration and home practice of 30 minutes 6X per week
overall duration of the intervention is 4 weeks
Intervention code [1] 256718 0
Rehabilitation
Intervention code [2] 256719 0
Lifestyle
Intervention code [3] 256720 0
Behaviour
Comparator / control treatment
Wait-listed control group / self management education
all participants will attend a single seminar prior to commencement of the intervention. Self management for BCRL includes simplified self massage, exercise, the use of compression and appropriate skin care. This group will continue with self managemetn for 5 weeks before participating inthe classes. (4 weeks for the intervention group to have classes and 1 week for collecting post intervention data.
Control group
Active

Outcomes
Primary outcome [1] 258683 0
Reduction in lymphoedema status as measured by bioimpedance spectroscopy (extracellular fluid), perometry (arm volume and circumference), tonometry (fibrotic induration) and self reported symptom scales and compared to the unaffected arm.
Timepoint [1] 258683 0
Post intervention
Secondary outcome [1] 264702 0
Increase in quality of life as measured using the Short Form 36 (SF-36), Adult Hope Scale (Snyder 2005) and a visual analogy scale on a global quality of life (QOL) question
Timepoint [1] 264702 0
Post Intervention

Eligibility
Key inclusion criteria
Women who have been treated for breast cancer more than 12 months previously, are disease free and have developed symptoms of BCRL as a result
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Body mass index (BMI) of 35 or over
1000ml or more of excess extracellular fluid in the affected arm compared to the unaffected arm as measured by bioimpedance spectroscopy
active malignancy
unable to participate in gentle exercise classes or current participation in a structured exercise program

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)
Volunteers will be processed for inclusion/exclusion criteria
Signed consent given
Group allocation by concealed allocation procedures involving distribution of prepared opaque envelopes at the self management seminar. The allocation will be made by a person who is off site to the seminar and was not involved in assessing volunteers for inclusion
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
concealed methods by an independent person using a randomisation table created by computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
all participants will attend a single self management education seminar and will perform their own self management program throughout the duration of the trial. The active group will be offered the intervention withe the waitlisted group as controls
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257195 0
Charities/Societies/Foundations
Name [1] 257195 0
Flinders Foundation
Country [1] 257195 0
Australia
Funding source category [2] 257196 0
Charities/Societies/Foundations
Name [2] 257196 0
Flinders Medical Centre Volunteer Service
Country [2] 257196 0
Australia
Primary sponsor type
University
Name
UniSA
Address
Frome Road
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 256451 0
University
Name [1] 256451 0
Flinders University
Address [1] 256451 0
Flinders Drive
Bedford Park SA 5042
Country [1] 256451 0
Australia
Other collaborator category [1] 251355 0
Hospital
Name [1] 251355 0
Flinders Surgical Oncology Clinic
Address [1] 251355 0
Car Park Building
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country [1] 251355 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259225 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 259225 0
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 259225 0
Australia
Date submitted for ethics approval [1] 259225 0
Approval date [1] 259225 0
16/06/2010
Ethics approval number [1] 259225 0
1/10/0105

Summary
Brief summary
this preliminary study aims to determine if yoga practice including adapted exercise, relaxation and meditation can reduce symptoms of BCRL and improve quality of life of women living with this condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31334 0
Address 31334 0
Country 31334 0
Phone 31334 0
Fax 31334 0
Email 31334 0
Contact person for public queries
Name 14581 0
Jan Douglass
Address 14581 0
4/45 Princes Street
Croydon SA 5008
Country 14581 0
Australia
Phone 14581 0
+61 419848589
Fax 14581 0
+61 8374 3469
Email 14581 0
jandouglass@bettanet.com.au
Contact person for scientific queries
Name 5509 0
Maarten Immink
Address 5509 0
UniSA
Frome Rd
Dept Health Sciences
Adelaide SA
5000
Country 5509 0
Australia
Phone 5509 0
+61 8 8302 2675
Fax 5509 0
Email 5509 0
maarten.immink@unisa.edu.au

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.