The aim of this study is determining the effect of yoga exercises on quality of life and arm volume in women with post mastectomy lymphedema
Design
This is a double-blind, randomized controlled trial that will be conducted with a pilot basis on 40 eligible patients admitted to the Motahari clinic in Shiraz.
Settings and conduct
This study examines the effect of yoga on patients with secondary lymph edema following mastectomy surgery at the lymph edema clinic of Motahhari infirmary , Shiraz. During the research, participants and main investigators will be unaware of the initial allocation of individuals to the intervention and control groups. Therefore, the trial will be done in double-blinded design.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Having tendency to participate in the research; having the ability to communicate verbally for cooperation; Women with secondary upper limb lymph edema followed by mastectomy confirmed by the clinician; Possibility to use DVD at home; Ability to move independently without the need for auxiliary equipment; At least one year interval from mastectomy surgery to entering the research. Exclusion criteria: Unwillingness to cooperate; Establishing any condition that can lead to exacerbation of illness or hospitalization; The history of congestive heart failure or chronic obstructive pulmonary disease; Patients under chemotherapy or radiotherapy; Having pacemaker; Pregnancy.
Intervention groups
An 8-week yoga practice, based on specific protocol, in addition to the usual care is considered for the intervention group, and observation group will receive standardize routine care of clinic.
Main outcome variables
Changes in quality of life assessed by questionnaire , Changes in arm volume assessed by water displacement volume meter [ Time Frame: baseline, 4 weeks, and 8 weeks after the yoga intervention]
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170925036390N1
Registration date:2017-12-03, 1396/09/12
Registration timing:prospective
Last update:2017-12-03, 1396/09/12
Update count:0
Registration date
2017-12-03, 1396/09/12
Registrant information
Name
nazanin barshan tashnizi
Name of organization / entity
shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 9487
Email address
stud2281502694@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
This study founding source is Deputy of Research and Technology of Shiraz University of Medical Sciences which is governmental .
Expected recruitment start date
2017-12-16, 1396/09/25
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Yoga exercise on quality of life and arm volume in women with post mastectomy Lymphedema
Public title
The effect of Yoga on women with post mastectomy Lymphedema
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having tendency to participate in the research
Having the ability to communicate verbally for cooperation
Women with secondary upper limb Lymphedema followed by mastectomy confirmed by the clinician
Possibility to use DVD at home
Ability to move independently without the need for auxiliary equipment
At least one year interval from mastectomy surgery to entering the research
Exclusion criteria:
Unwillingness to cooperate
Establishing any condition that can lead to exacerbation of illness or hospitalization
The history of congestive heart failure or chronic obstructive pulmonary disease
Patients under chemotherapy or radiotherapy
Having pacemaker
Pregnancy
Age
From 18 years old to 85 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will select according to study inclusion criteria and based on the target. Then they are randomly assigned to two groups using a random number table by block randomization method.
First, researcher assistant writes all of the permutations A (representing the intervention group) and B (representing the control group), which consists of 6 different modes. Then, to allocate individuals with random number table, the finger moves randomly from a random point table to the row or column. If the number is between one and six, the permutation of that number is noted. For example, if the number 6 arrives, we will record ABAB permutations, and thus eligible patients will be in the control group and in the intervention group (yoga practice group)
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be performed in Double blind method so that the first researcher assistant contributes to the initial selection of patients, the completion of the questionnaire and random allocation, so the participants, investigator and even the care providers are unaware of the study groups. In this way, at the times of arm volume control and completing the questionnaire, the participants will not have any information about the allocation of the groups. Data will be imported and analyzed by a non-informed data analyzer, and ultimately the results of the final analysis will be communicated to the researchers.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz, Zand Avenue, Central Building of the University of Medical Sciences
City
shiraz
Province
Fars
Postal code
713451978
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.SUMS.REC.1396.108
Health conditions studied
1
Description of health condition studied
Postmastectomy lymphoedema syndrome
ICD-10 code
I97.2
ICD-10 code description
Postmastectomy lymphoedema syndrome
Primary outcomes
1
Description
Quality of Life
Timepoint
at baseline, 4 weeks, and 8 weeks after the intervention
Method of measurement
a specific quality of life assessment questionnaire for cancer patients
2
Description
arm volume
Timepoint
at baseline, 4 weeks, and 8 weeks after the intervention
Method of measurement
water displacement volumeter
Secondary outcomes
empty
Intervention groups
1
Description
The intervention of this study is yoga exercise for 8 weeks( 3 sessions in each week ). Two sessions of the weekly schedule will held in one hour at clinic training hall and under the supervision of the trained person and one session of it at home by pat
Category
Rehabilitation
2
Description
The observation group will receive standardize routine care of lymphedema clinic and will evaluate at three time steps.