Determining the effect of yoga on the volume of edema and the quality of life of women with upper limb lymphedema caused by breast cancer
Design
randomised, tow arm parallel group design of 110 patients with unblinded outcome assessment,The method of randomization intotwo groups willbe done with permutation block (of four).
Settings and conduct
Sampling will be done in Afzalipur Hospital, Kerman,according to the Inclusion and exclusion criteria of the study. The participants will be included in the study using available sampling, then they will be placed in two intervention groups with the method of yoga exercise and the control group using permutation blocks (quadruple). The intervention group will do online yoga using Instagram software for eight weeks and two one-hour sessions per week under the guidance of the instructor.Patients in the control group will receive only the routine follow-ups.
Participants/Inclusion and exclusion criteria
Inclusion criteria; Lymphedema of the upper limb diagnosed by a doctor
Adult age above 18 years to 65 years
The time interval of at least one month since the last surgical treatment and the time interval since the onset of lymphedema is a maximum of two years
Absence of physical and sports activities during the last six months
Absence of underlying and cognitive disease
Exclusion criteria: patients with breast cancer referred to the oncology department; Patients with cancer recurrence and underlying and cognitive diseases
Intervention groups
The intervention group will do online yoga using Instagram software for eight weeks and two one-hour sessions per week under the guidance of the instructor. Patients in the control group will only receive routine follow-ups in the ward.
Main outcome variables
volume of lymphedema and the quality of life of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220817055734N1
Registration date:2022-09-29, 1401/07/07
Registration timing:registered_while_recruiting
Last update:2022-09-29, 1401/07/07
Update count:0
Registration date
2022-09-29, 1401/07/07
Registrant information
Name
samira beigmoradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4242 1155
Email address
samirabeig2018@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Yoga on Lymphedema Volume and Quality of Life in women wih breast cancer
Public title
Investigating the effect of yoga on the volume of hand edema and the quality of life of women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Lymphedema of the upper limb diagnosed by a doctor
Adult age above 18 years to 65 years
The time interval of at least one month since the last surgical treatment and the time interval since the onset of lymphedema is a maximum of two years
Absence of physical and sports activities during the last six months
Absence of underlying and cognitive disease
Exclusion criteria:
Recurrence of the disease
Another cancer
Failure to participate in more than three sessions of yoga exercises
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be included in the study using available sampling, Then, by randomly assigning the samples, they are divided into intervention and control groups. The method of randomization into two groups will be done with permutation block (of four). In this way, considering that we have 112 samples, we will have 28 blocks of 4. In total, we have 4 blocks out of 6, that is AABB، BBAA ،ABAB ،BABA، ABBA and BAAB, A will be the intervention group and B will be the control group.To randomly select blocks 1 to 6, this can be done using Excel or R software until the 28th block is selected, With this method, an equal number of people will be placed in two groups completely randomly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of sirjan school of Medical Sciences
Street address
ebne sina ave.
City
sirjan
Province
Kerman
Postal code
7851817783
Approval date
2022-08-28, 1401/06/06
Ethics committee reference number
IR.SIRUMS.REC.1401.005
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
The volume of lymphedema of the upper limb using a volumetric tank
Timepoint
Measurement of upper limb lymphedema volume at the beginning of the study and at the end of the eighth week (after the study was completed)
Method of measurement
Measuring the volume of edema with the method of water displacement, which is the gold standard method, uses a volume meter tank.
Secondary outcomes
1
Description
Quality of life using a lymphedema Life Impact Scale questionnaire
Timepoint
Measurement of quality of life at the beginning of the study and at the end of the eighth week (after the study was completed)
Method of measurement
The questionnaire of lymphedema Life Impact Scale (LLIS) consists of 18 questions that measure the impact of lymphedema on different dimensions of life.
Intervention groups
1
Description
Intervention group: Yoga exercise, eight weeks, two one-hour sessions every week online under the guidance of an experienced trainer in this field
Category
Rehabilitation
2
Description
Control group: The control group will receive only the routine follow-ups performed in the ward
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
afzalipour hospital
Full name of responsible person
samira beigmoradi
Street address
emam highway
City
kerman
Province
Kerman
Postal code
7851817783
Phone
+98 34 3222 2250
Email
samira.beigmoradi4002@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sirjan school of Medical Sciences
Full name of responsible person
Dr mahmoudreza masoudi
Street address
ebne sina ave.
City
sirjan
Province
Kerman
Postal code
7851817783
Phone
+98 34 4223 2052
Email
samira.beigmoradi4002@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sirjan school of Medical Sciences
Proportion provided by this source
90
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
دانشکده علوم پزشکی سیرجان
Full name of responsible person
samira beigmoradi
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
ebne sina ave
City
sirjan
Province
Kerman
Postal code
7851817783
Phone
+98 34 4223 2052
Email
samira.beigmoradi4002@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sirjan school of Medical Sciences
Full name of responsible person
samira beigmoradi
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
ebne sina ave
City
sirjan
Province
Kerman
Postal code
7851817783
Phone
+98 34 4223 2052
Email
samira.beigmoradi4002@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sirjan school of Medical Sciences
Full name of responsible person
samira beigmoradi
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
ebne sina ave
City
sirjan
Province
Kerman
Postal code
7851817783
Phone
+98 34 4223 2052
Email
samira.beigmoradi4002@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after de-identifying people.
When the data will become available and for how long
4 months after publishing the results
To whom data/document is available
sirjan school of medical science
Under which criteria data/document could be used
Using data to conduct other studies
From where data/document is obtainable
sirjan school of medical science, samira beigmoradi
What processes are involved for a request to access data/document
Email should be sent first and after coordination, the data will be provided to the applicant by visiting in person