Determine the effect of exercise program on the quality of life of survivors of prostate cancer
Design
In this study, survivors of prostate cancer who had a medical record in the center of radiotherapy at Imam Khomeini Hospital in Tehran and had criteria for entering the study, were the sample of the study. Patients with selected entry criteria were selected by random sampling method. A random sample of 80 people entered the study and randomly divided into intervention and control groups. To conceal the intervention group, each participant had a code is assigned.
Settings and conduct
Patients in the intervention group were divided into 5 groups of 8, according to their area of living and their convenient access to sports facilities in the park near the place of residence. At first, the benefits of physical activity and how the exercise program was performed during the research period by the researcher was taught to the participants in each of the 5 groups and a exercise program was provided to them. Regarding the coordination with the municipality of Tehran, the patients in the intervention group during the study, which lasted for 12 weeks, performed one weekly session in a group under the supervision of a researcher in the park's physical environment and three sessions per week individually. Aerobic walking was performed in walking style with mild to moderate intensity (based on patient tolerance). Resistive exercise movements were performed for muscle strength with mild to moderate intensity (based on patient tolerance) for each large muscle group twice a week, once grouped. Stretching exercises for pulling of the main muscles and tendons were also done twice a week in a single session, individually and one session. In addition, patients with urinary incontinence were trained and recommended for pelvic floor exercise، Which performs these movements daily.
Questionnaires related to quality of life were completed before and after the intervention in both control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients diagnosed with prostate cancer and completed active treatment within 3 to 12 months
The absence of metastasis to other locations
The absence of neurological, cardiovascular, respiratory or any disorder that prevents physical activity.
At least 45 years of age
exclusion criteria:
Changes in health condition that prevent physical activity
Intervention groups
In this study there is an intervention group that carries out exercise exercises.
And there is a control group that there will be no action or intervention in this group.
Main outcome variables
quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180113038347N1
Registration date:2018-01-23, 1396/11/03
Registration timing:retrospective
Last update:2018-01-23, 1396/11/03
Update count:0
Registration date
2018-01-23, 1396/11/03
Registrant information
Name
Abbas Mardani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3370 8095
Email address
abbasmardani30@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-21, 1396/02/31
Expected recruitment end date
2017-10-21, 1396/07/29
Actual recruitment start date
2017-05-21, 1396/02/31
Actual recruitment end date
2017-12-20, 1396/09/29
Trial completion date
empty
Scientific title
The effect of the motion exercise program on the quality of life in prostate cancer survivors
Public title
"The effect of the motion exercise program on the quality of life in prostate cancer survivors"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with prostate cancer and completed active treatment within the past 3 to12 months
Lack of metastasis
The absence of neurological, cardiovascular, respiratory or any other problems that prevent physical activity
At least 45 years of age
Conscious consent to participate in the study
Residence in Tehran
Exclusion criteria:
Absent more than three sessions in group exercise sessions
Changes in health condition that prevent physical activity
Age
From 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
71
Randomization (investigator's opinion)
Randomized
Randomization description
The method of sampling in this research is simple random sampling using random numbers table. In this way, patients with prostate cancer who have criteria for entering the study are selected, then each patient is given a code and using the random numbers table, the first code is equal or smaller than the number of patients eligible for the study Enter the control group and one in each patient according to the code assigned to the intervention and control group, and to some extent in the random numbers table we go to each of the intervention and control groups of 40 patients.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی تهران
Street address
Tehran University of Medical Sciences, Nursing and Midwifery Faculty, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-05-02, 1396/02/12
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2209
Health conditions studied
1
Description of health condition studied
Prostate Cancer Survivors
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
Quality of Life
Timepoint
At the beginning of the study (before the intervention) and after the end of the intervention (duration of intervention 12 weeks)
Method of measurement
Using EORTC QLQ-C30 Quality of Life Questionnaire. V 3 and EORTC QLQ-PR25 belonging to the European Cancer Research & Treatment Organization.These two complementary questionnaires are also used to measure the quality of life of patients with prostate cancer.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group were divided into 5 groups of 8, according to their area of living and their convenient access to sports facilities in the park near the place of residence. At first, the benefits of physical activity and how the exercise program was performed during the research period by the researcher was taught to the participants in each of the 5 groups and a motor exercise program was provided to them. Regarding the coordination with the municipality of Tehran, the patients in the intervention group during the study, which lasted for 12 weeks, performed one weekly session in a group under the supervision of a researcher in the park's physical environment and three sessions per week individually. Aerobic walking was performed in walking style with moderate to moderate intensity (based on patient tolerance). Resistive exercise movements were performed for muscle strength with moderate to moderate intensity (based on patient tolerance) for each large muscle group twice a week, once grouped. Stretching exercises for pulling the main muscles and tendons were also performed twice a week in a single session, individually and one session. In addition, patients with urinary incontinence were trained and recommended for pelvic floor exercise. Which performs these movements daily.
Category
N/A
2
Description
Control group: No specific action was taken in patients in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان آموزشی امام خمینی شهرتهران وابسته به دانشگاه علوم پزشکی تهران
Full name of responsible person
عباس مردانی
Street address
Imam Khomeini Hospital، East Nusrat Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
abbasmardani30@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Tehran University of Medical Sciences
Full name of responsible person
Shadan Pedram Razi
Street address
Tehran University of Medical Sciences, Nursing and Midwifery Faculty, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8889 6696
Email
pedramrazi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Abbas mardani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran University of Medical Sciences, Nursing and Midwifery Faculty, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
abbasmardani30@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shadan Pedram Razi
Position
The coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran University of Medical Sciences, Nursing and Midwifery Faculty, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
pedramrazi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Mardani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran University of Medical Sciences, Nursing and Midwifery Faculty, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
abbasmardani30@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To protect the privacy of the participants in the study