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Trial registered on ANZCTR


Registration number
ACTRN12611000202965
Ethics application status
Approved
Date submitted
18/02/2011
Date registered
21/02/2011
Date last updated
28/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of yoga on women with secondary lymphoedema from breast cancer treatment. A pilot trial.
Scientific title
The effect of yoga on strength, range of motion and quality of life in women with secondary lymphoedema from breast cancer treatment. A randomised controlled pilot trial.
Secondary ID [1] 259638 0
University of Tasmania Social Sciences Human Research Ethics Committee H11534
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Secondary arm lymphoedema in breast cancer survivors 261204 0
Condition category
Condition code
Cancer 259354 259354 0 0
Breast
Cardiovascular 259364 259364 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An eight week yoga intervention consisting of one 90 minute supervised and six 45 minute home based yoga classes per week. The type of yoga is Hatha yoga based on Satyananda teachings. The supervised session will be conducted in groups consisting of 5-12 participants.
Intervention code [1] 258070 0
Treatment: Other
Intervention code [2] 258079 0
Lifestyle
Comparator / control treatment
Usual care consists of manual lymphatic drainage if required and current best practice self management including treatments such as personal skin care, self massage, specific exercises and elevation of the arm.
Control group
Active

Outcomes
Primary outcome [1] 262167 0
Arm lymphoedema via measurements of arm volume, bio-impedance and tonometer measurements
Timepoint [1] 262167 0
baseline, week 4, week 8 and 4 weeks post intervention
Secondary outcome [1] 273258 0
Shoulder range of motion using goniometry
Timepoint [1] 273258 0
baseline, week 4, week 8 and 4 weeks post intervention
Secondary outcome [2] 273259 0
Isometric shoulder and grip strength using dynamometry
Timepoint [2] 273259 0
baseline, week 4, week 8 and 4 weeks post intervention
Secondary outcome [3] 273260 0
Spinal mobility felxion/extension, lateral flexion and rotation) using an opto electronic motion analysis system for calculation of angles of motion.
Timepoint [3] 273260 0
baseline, week 4, week 8 and 4 weeks post intervention
Secondary outcome [4] 273261 0
Quality of Life Questionnaire - LYMQOL
Timepoint [4] 273261 0
baseline, week 4, week 8 and 4 weeks post intervention

Eligibility
Key inclusion criteria
Women need to have completed all treatment for breast cancer at least 6 months previously;
Women need to comprehend English in order to understand the written forms, and oral instructions;
and have confirmed unilateral secondary lymphoedema related to surgery for breast cancer stage one, with volume being 10% greater than non-affected arm (dominant hand will be noted);
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women will be excluded if they have primary lymphoedema, recurrent cancer, other symptoms including infection or cellulitis as all of these will affect the woman’s lymphoedema and her quality of life adversely;
Women with severe psychological illness will be excluded as the yoga intervention needs to be specific to the person’s psychological illness in order to improve it;
Women with dementia and language problems will be excluded as they may not be able to fully comprehend the yoga instruction;
Pregnant women and women with pacemakers will be excluded as these conditions are contra-indicated for the use of bio-impedance spectroscopy – one of the measuring tools for this study (Czerniec et al 2010 p 55);
Women will be excluded if they are having current lymphoedema treatment other than self-management, as this will affect their results;
If women need lymphoedema treatment during the study they can continue in the study but measurements will not be analysed;
Women currently doing yoga or another intervention such as attending a local Encore group, due to the potential for the other treatment to affect the results, will also be excluded.

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)
Treatment allocated by a third party not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by coin-toss
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)
TAS
Recruitment postcode(s) [1] 3626 0
7250
Recruitment postcode(s) [2] 3627 0
7005

Funding & Sponsors
Funding source category [1] 258532 0
Self funded/Unfunded
Name [1] 258532 0
Address [1] 258532 0
Country [1] 258532 0
Primary sponsor type
University
Name
University of Tasmania
Address
University Department of Rural Health
Locked Bag 1372
Launceston TAS 7250
Country
Australia
Secondary sponsor category [1] 257668 0
None
Name [1] 257668 0
Address [1] 257668 0
Country [1] 257668 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260503 0
Social Sciences Human Research Ethics Committee
Ethics committee address [1] 260503 0
Ethics committee country [1] 260503 0
Australia
Date submitted for ethics approval [1] 260503 0
Approval date [1] 260503 0
16/12/2010
Ethics approval number [1] 260503 0
H11534

Summary
Brief summary
The lymphatic transport system provides the way for extra-cellular fluid and other substances to be transported back to the venous system. This fluid is taken up by lymph capillaries, flows into lymph collectors, then to lymph nodes in various parts of the body. Each part of the body flows to its own nodes eg fluid from the left arm will flow to the axilla under the left arm. In Australia a major cause for disruption to the lymphatic system is surgery and radiation therapy. Breast cancer treatment commonly includes modified radical mastectomy surgery, radiation to the chest wall, and removal of lymph nodes. These treatments all contribute to disruptions in lymphatic system function. Secondary arm lymphoedema after treatment from breast cancer occurs in at least 20% of women although this figure is usually quoted as being higher.

Research into the effects and benefits of different exercise modalities for women with secondary arm lymphoedema as a result of breast cancer treatment have shown that various types of exercise do not worsen lymphoedema - as long as the exercise is given in a supervised and controlled way, with adequate warm-up and cool-down. Women also report that attending a group exercise class helps keep them motivated to continue with their self-management regime. Recently, studies based on tai-chi and breathing and gentle exercises including breathing and relaxation, have led to slight decreases in the amount of fluid in the affected arm.

Yoga has been reported to lower levels of anxiety and depression and improve quality of life and immune function in women. However to date there has been no investigation on the effectiveness of yoga in the treatment of lympoedema.

This study will examine the effects of an eight week yoga intervention on lymphoedema in breast cancer survivors. A range of measures of degree of lympoedema, strength, range of motion and quality of life will be measured in women on commencement and after four and eight weeks of a yoga intervention and at four weeks after completion of the intervention. Results will be compared with a control group who receive usual care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32239 0
Address 32239 0
Country 32239 0
Phone 32239 0
Fax 32239 0
Email 32239 0
Contact person for public queries
Name 15486 0
Tony Barnett
Address 15486 0
University Department of Rural Health
University of Tasmania
Locked Bag 1372
Launceston TAS 7250
Country 15486 0
Australia
Phone 15486 0
+61 3 6324 4011
Fax 15486 0
+61 3 6324 4040
Email 15486 0
Tony.Barnett@utas.edu.au
Contact person for scientific queries
Name 6414 0
Tony Barnett
Address 6414 0
University Department of Rural Health
University of Tasmania
Locked Bag 1372
Launceston TAS 7250
Country 6414 0
Australia
Phone 6414 0
+61 3 6324 4011
Fax 6414 0
Email 6414 0
Tony.Barnett@utas.edu.au

No information has been provided regarding IPD availability
Summary results
No Results