Determining the effect of an aerobic and stretching exercise program on self-efficacy and mental health of breast cancer patients referred to Seyed al-Shohada Hospital (A) and Al-Zahra Subspecialty Clinic (S) in Isfahan.
Design
Clinical trial with control group, with parallel groups, randomized, on 64 patients. A random block is used for randomization.
Settings and conduct
The samples will be selected from those who meet the inclusion criteria from women with breast cancer referring to the chemotherapy clinic of Seyed Al-Shahada Hospital, and then they will be randomly assigned to two test or control groups. became. According to the sports program compiled by the physical education specialist, in this research, sports intervention will be carried out in the intervention group during eight weeks, three sessions per week and each session will last 35 to 40 minutes. Before the start of the intervention and after the end of the eighth week, questionnaires will be completed in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients who are aware of the diagnosis of their disease.
2. Patients who have the ability to speak and communicate verbally.
3. Cancer patients who have been diagnosed for at least one month
Exclusion criteria:
1. Patients who are treated with anticoagulant drugs
2. Patients who have been treated with radiotherapy before chemotherapy.
Intervention groups
for the intervention group; According to the sports program compiled by the physical education specialist, in this research, sports intervention will be done in the intervention group during eight weeks and three sessions per week (24 sessions in total) and each session will be 35 to 40 minutes.
No sports intervention will be done for the control group and they will only receive routine care.
Main outcome variables
Self Efficacy; mental health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141127020108N4
Registration date:2022-07-17, 1401/04/26
Registration timing:prospective
Last update:2022-07-17, 1401/04/26
Update count:0
Registration date
2022-07-17, 1401/04/26
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 2856
Email address
musarezaie@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an Aerobic and stretching exercise program on Self-Efficacy and mental health in breast cancer women
Public title
The effect of an Aerobic and stretching exercise program on Self-Efficacy and mental health
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are aware of their disease diagnosis.
Patients who have the ability to speak and communicate verbally.
Patients who are interested in participating in the study.
Cancer patients who have been diagnosed for at least one month
Patients who have completed at least two chemotherapy sessions.
Exclusion criteria:
Patients with mental retardation, blindness, deafness, physical problems and mobility disabilities
Patients with any metastases.
Patients who are treated with anticoagulant drugs.
Patients who have been treated with radiotherapy before chemotherapy.
Patients who have a history of any type of cancer other than breast cancer.
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:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the block randomization method. Blocking is usually used to balance the number of samples assigned to each of the study groups. The size of all blocks is equal and we will have 4 groups of 4 blocks (including 2 participants in the intervention group and 2 participants in the control group) in this two-group experiment. In this way, we will have 16 blocks of 4 that will divide people into two groups of 32 people. Randomization tool also uses software random allocation software (Random allocation software) that these random sequence generation software in addition to simple randomization are able to generate random sequence by blocking method. Using opaque sealed envelopes, each of the random sequences created is recorded on a card, and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
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
Research Ethics Committees of Nursing, Rehabilitation and Management schools- Isfahan University of
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-07-03, 1401/04/12
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.047
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 score obtained from the general self-efficacy questionnaire
Timepoint
Immediately before and immediately after the intervention
Method of measurement
Sherer General Self-Efficacy Scale
Secondary outcomes
1
Description
The score obtained from Depression, anxiety and stress questionnaire DASS-42
Timepoint
Immediately before and immediately after the intervention
Method of measurement
Depression, anxiety and stress questionnaire DASS-42
Intervention groups
1
Description
Intervention group:According to the sports program developed by a physical education specialist, in this research, sports intervention will be carried out in the intervention group for eight weeks, three sessions per week, each session lasting 35 to 40 minutes. In this study, the exercise protocol will be structured and at home, including three parts: warming up, aerobic exercises and cooling down. On the first day, the prepared package including the required sports equipment, a CD containing training videos of sports movements, an illustrated training booklet and an internet package with a volume of five GB will be provided to the participants.On the day of delivery of equipment and supplies, all sports movements are taught to the patients by the researcher. After the training, in order to ensure the correctness of the learning, the patients are asked to perform each exercise in the presence of the researcher. After providing the necessary training and performing physical exercises, the patients will be added to a WhatsApp group by the researcher. Before the start of the intervention, the questionnaires will be completed in person. After the end of the eighth week in the intervention group, the questionnaires will be completed online through the WhatsApp group.
Category
Other
2
Description
Control group: The control group received only routine care and completed questionnaires immediately before and after the end of the study.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyyed al-Shohada Hospital
Full name of responsible person
Amir Musa Rezaei
Street address
Motahari St., Seyed al-Shohada Hospital
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
2
Recruitment center
Name of recruitment center
Al-Zahra Specialist Clinic
Full name of responsible person
Amir Musa Rezaei
Street address
Sheikh Mofid Street, Al Zahra Special Clinic
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mansour Siavash
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amir Musa Rezaei
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Musa Rezaei
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Musa Rezaei
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available