Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000584538
Ethics application status
Approved
Date submitted
15/05/2015
Date registered
3/06/2015
Date last updated
6/08/2019
Date data sharing statement initially provided
6/08/2019
Date results information initially provided
6/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of GYROKINESIS 'Registered Trademark' training in breast cancer survivors
Scientific title
Effectiveness of GYROKINESIS 'Registered Trademark'-based Training on Physical Function and Quality of Life in Breast Cancer Survivors
Secondary ID [1] 286712 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer survivors 295071 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295320 295320 0 0
Physiotherapy
Cancer 295448 295448 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive GYROKINESIS 'Registered Trademark' exercise training twice a week, lasting for 12 weeks in total. The exercise training will be delivered in a group format with a physiotherapist.

The duration of each training session will be 60-90 minutes long. Each class begins on a chair with a gentle warm up sequence to awaken the senses, and stimulate the nervous system. This is followed by a series of fluid spinal motions which increase range of motion, and prepare the body to explore more complex movements with agility, and ease. Class continues on the floor with exercises that expand on the spinal motions, gradually adding more complex sequences, incorporating more movements of the hips, shoulders, hands and feet. The floor exercises are followed by a rhythmic standing sequence that incorporates balance, and cardiovascular exercises.
Intervention code [1] 291866 0
Treatment: Other
Intervention code [2] 291867 0
Rehabilitation
Comparator / control treatment
Participants in control group will be given one 1-hour session of verbal instruction regarding some exercise suggestions based on their personal interests by a physiotherapist. They will also maintain their usual daily activities.
Control group
Active

Outcomes
Primary outcome [1] 295061 0
Movement freedom: Freedom of movement inventory
Timepoint [1] 295061 0
baseline, immediately after 12-week intervention, and at 4 weeks after intervention
Primary outcome [2] 295178 0
Thoracic mobility: a digital inclinometer set
Timepoint [2] 295178 0
baseline, and immediately after 12-week intervention
Secondary outcome [1] 314683 0
Shoulder mobility: goniometer
Timepoint [1] 314683 0
baseline, and immediately after 12-week intervention
Secondary outcome [2] 314958 0
Quality of Life: Traditional Chinese version of FACT-B questionnaire
Timepoint [2] 314958 0
baseline, immediately after 12-week intervention, and at 4 weeks after intervention
Secondary outcome [3] 314960 0
Perceived improvement: Global rating of change score (GRCS)
Timepoint [3] 314960 0
baseline, immediately after 12-week intervention, and at 4 weeks after intervention
Secondary outcome [4] 322038 0
Thoracic kyphosis angle
Thoracic kyphosis angle was measured with a dual digital inclinometer (MicroFET6, HOGGAN Health Industries, Inc. 8020 South 1300 West, West Jordan, UT 84088) in habitual standing and sitting postures.
As for habitual standing postures, participants were asked to stand in their usual posture with barefoot and with feet hip-width apart. First, the dual digital inclinometers (DDI) were placed on a known horizontal surface to reset to zero prior to measurement. Then the DDI sensors were placed on the spinous processes of T1 and T12 respectively. The degree of thoracic kyphosis was read from the inclinometer screen, and the measurements were performed three times in succession for calculating the average value.
As for habitual sitting posture, participants sat on a chair with hips flexed and knees flexed in 90 degrees, feet flat on the floor, arms hang comfortably along the body, and trunk in usual posture. DDI was reset to zero prior to measurement, and the sensors were placed on the spinous processes of T1 and T12 respectively. The degree of thoracic kyphosis was recorded, and the measurements were performed three times in succession for calculating the average value.
Timepoint [4] 322038 0
baseline. immediately after 12-week intervention

Eligibility
Key inclusion criteria
(1) female, (2) diagnosed of stage 0-IV breast cancer, (3) within 5 years after finishing adjuvant therapy
Minimum age
20 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) active cancer, (2) under adjuvant therapy, (3) neurologic or rheumatic diseases, or (4) severe cardiovascular condition or other medical conditions

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/09/2014
Actual
24/09/2014
Date of last participant enrolment
Anticipated
Actual
3/09/2015
Date of last data collection
Anticipated
Actual
3/03/2016
Sample size
Target
80
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 6880 0
Taiwan, Province Of China
State/province [1] 6880 0

Funding & Sponsors
Funding source category [1] 291275 0
Self funded/Unfunded
Name [1] 291275 0
Wendy Tzyy-Jiuan Wang
Country [1] 291275 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-Ming University
Address
155, Sec. 2, Li-Nong St. Beitou District, Taipei, 11221
Country
Taiwan, Province Of China
Secondary sponsor category [1] 289948 0
Hospital
Name [1] 289948 0
Chen Hsin General Hospital
Address [1] 289948 0
No.45, Cheng Hsin St.,Baitou District,Taipei, 11220
Country [1] 289948 0
Taiwan, Province Of China
Secondary sponsor category [2] 289949 0
Charities/Societies/Foundations
Name [2] 289949 0
Taiwan breast cancer Foundation
Address [2] 289949 0
No 7, Alley 6, Sec. 1, Hangzhou S. Rd., Zhongzheng District, Taipei, 10050
Country [2] 289949 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292835 0
Institutional Review Board of Cheng Hsin General Hospital
Ethics committee address [1] 292835 0
No. 45, Cheng Hsin St., Beitou District, Taipei, 11220
Ethics committee country [1] 292835 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 292835 0
Approval date [1] 292835 0
08/07/2014
Ethics approval number [1] 292835 0

Summary
Brief summary
Many breast cancer survivors suffered from restrictions in quality of life and impaired physical and psychological function after finishing radiotherapy and chemotherapy, but current exercise interventions cannot provide all-round effect to treatment sequelae. GYROKINESIS 'Registered Trademark' is a new method containing flowing movement sequences that works the entire body, yet its clinical effects have not been investigated and have not been applied in the breast cancer population. The purpose of this study is to investigate the effectiveness of GYROKINESIS 'Registered Trademark' -based training on physical function and quality of life in breast cancer survivors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57278 0
A/Prof Wendy Tzyy-Jiuan Wang
Address 57278 0
155, Sec. 2, Li-Nong St. Beitou District, Taipei, 11221
National Yang-Ming University
Country 57278 0
Taiwan, Province Of China
Phone 57278 0
+886228267091
Fax 57278 0
+886228201841
Email 57278 0
[email protected]
Contact person for public queries
Name 57279 0
A/Prof Wendy Tzyy-Jiuan Wang
Address 57279 0
155, Sec. 2, Li-Nong St. Beitou District, Taipei, 11221
National Yang-Ming University
Country 57279 0
Taiwan, Province Of China
Phone 57279 0
+886228267091
Fax 57279 0
+886228201841
Email 57279 0
[email protected]
Contact person for scientific queries
Name 57280 0
A/Prof Wendy Tzyy-Jiuan Wang
Address 57280 0
155, Sec. 2, Li-Nong St. Beitou District, Taipei, 11221
National Yang-Ming University
Country 57280 0
Taiwan, Province Of China
Phone 57280 0
+886228267091
Fax 57280 0
+886228201841
Email 57280 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Further privacy concern needs to be considered.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3733Ethical approval  [email protected] 368555-(Uploaded-02-08-2019-19-57-17)-Study-related document.pdf



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.