The effect of motor exercises on quality of life, depression and anxiety in women with breast cancer
Design
First, both control and experimental groups complete the questionnaires as pre-test. According to inclusion and exclusion criteria, they are randomly divided into two groups. The written consent of the research participant is obtained. Both groups will then undergo a 6-minute walk test and shoulder joint test. The intervention is then followed by 5 weeks of regular walking and arm movements. At the end of 5 weeks, both groups will receive post-test.
Settings and conduct
The study is a randomized controlled clinical trial at Imam Khomeini Hospital in Sari.
Participants/Inclusion and exclusion criteria
Inclusion: Women with non-metastatic non-postmenopausal breast cancer, over 18 years old, one or both breast discharges Exclusion: Subject's unwillingness to continue the intervention
Intervention groups
Questionnaires will be completed by the oncology surgeon, followed by a 6-minute walk test and shoulder joint range of motion measurements. The motor exercises used for the intervention group are selected in consultation with the sports medicine specialist and the patient's physician. And the intervention is a 5-week regular walk and arm movements.
Main outcome variables
Quality of life, depression, anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200228046637N1
Registration date:2020-04-03, 1399/01/15
Registration timing:registered_while_recruiting
Last update:2020-04-03, 1399/01/15
Update count:0
Registration date
2020-04-03, 1399/01/15
Registrant information
Name
Iran Ghasemi Cherati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4255 4211
Email address
s.ghasemi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-07, 1398/07/15
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of motor exercises on quality of life, depression and anxiety in women with breast cancer
Public title
The effect of motor exercises on quality of life, depression and anxiety in women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
women with breast cancer
Non-metastatic
non-postmenopausal
over 18 years of age
at least literate
one or both breast drains
The drain has been removed
no psychological treatment experience
no drug addiction
No heart disease
No respiratory disease
no history of regular physical activity one year prior to the study
patient consent to participate in research
and written consent
Exclusion criteria:
Subject's unwillingness to continue the intervention
physical disability of the intervention due to treatment periods
Unable to walk
Unable to stand
People with a HADS questionnaire score of less than 11.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are numbered on entry to the treatment center and will be assigned to one of the intervention or control groups using random numbers table and simple randomization method.
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
Imam Educational Hospital of Sari-Mazandaran University of Medical Sciences
Street address
Sari-Shahband Street-Vesal square-Nasibeh School of Nursing and Midwifery
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.062
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
Quality of Life
Timepoint
Before intervention - 5 weeks later
Method of measurement
1) QLQ-C30 specific quality of life questionnaire and 2 quality of life questionnaire for breast cancer patients: EORTC QLQ-C23.V.3
2
Description
depression and anxiety
Timepoint
Before intervention - 5 weeks later
Method of measurement
HADS Hospital Expression and Anxiety Questionnaire
Secondary outcomes
1
Description
Level of physical fitness
Timepoint
Before surgery, after drainage, 5 weeks later
Method of measurement
6 minute walk test
2
Description
Joint angles and axis view of joint motion
Timepoint
Goniometer
Method of measurement
Before surgery, after drainage, 5 weeks later
Intervention groups
1
Description
Intervention group: Depression, quality of life and demographic questionnaires will be completed as a pre-test. The written consent of the research firm is obtained from them. Motion training is provided by a research associate (sports medicine specialist).Then a 6-minute walk test is performed for the patients to assess their fitness level and to measure shoulder joint range of motion with goniometer. The exercises that are used are selected in consultation with a specialist in sports medicine and patients. The intervention will then be administered to the patients for a 5-week regular walk and arm movements with pamphlets.Arm exercises begin on the second day after surgery and are performed 3 times a week for 20 minutes each time for 5 weeks. If the patient feels uncomfortable, taking a warm shower before exercise can also reduce joint stiffness and ease. Subjects are told that there is no compulsion to continue activities during the sessions and that they can be discouraged if they experience slight fatigue and unpleasant feelings. After the training, the post-test will also be repeated to assess the difference between the groups and the impact of the interventions.
Category
Rehabilitation
2
Description
Control group: First, the goals of the research will be explained to them, and then as a pre-test, they will complete the Depression, Quality of Life and Demographic Questionnaires. Based on the results of the questionnaires and according to the inclusion and exclusion criteria of the eligible people, they are randomly assigned to the control group. They are asked not to participate in any organized exercise program during this time. After 5 weeks, they will be tested again to assess the difference between the groups. At the end of the intervention, participants will be instructed on the ethical considerations of walking and arm movements. And a pamphlet is given to them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Seyed Hamzeh Hosseini
Street address
Sari-Shahband Street-Vesal square-Nasibeh School of Nursing and Midwifery
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5555
Email
fahime.ghasemi24@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Sari-Shahband Street-Vesal square-Nasibeh School of Nursing and Midwifery
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5555
Fax
+98 11 3335 2725
Email
fahime.ghasemi24@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
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
Mazandaran University of Medical Sciences
Full name of responsible person
Fahimeh Ghasemi Cherati
Position
MSC.Lecturer,Department of Medical Surgery Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sari-Shahband Street-Vesal square-Nasibeh School of Nursing and Midwifery
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5555
Email
fahime.ghasemi24@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vida Shafipour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sari-Shahband Street-Vesal square-Nasibeh School of Nursing and Midwifery
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5555
Email
shafivida@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fahimeh Ghasemi Cherati
Position
MSC.Lecturer,Department of Medical Surgery Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sari-Shahband Street-Vesal square-Nasibeh School of Nursing and Midwifery
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5555
Email
fahime.ghasemi24@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
Primary and secondary outcome information is shared anonymously.
When the data will become available and for how long
Access started 6 months after the results were published.
To whom data/document is available
Accessible to all researchers working in academic institutions and specialists in breast surgery
Under which criteria data/document could be used
The results of documentation and data can be used for or not to be used on breast surgery patients.
From where data/document is obtainable
The person responsible for the public accountability of the study can provide information to eligible individuals. Fahimeh Qasemi Cherati,
fahime.ghasemi24@gmail.com
What processes are involved for a request to access data/document
If the person is eligible to request access to the documentation, it will be attempted to provide it as soon as possible after it has been demonstrated that the person is authorized to access the data.
Comments
I hope that the results of the research will help improve the condition of patients.