Comparing the average score of quality of life and anxiety of breast cancer patients in the exercise group at home with the exercise group in centers (group exercise)
Design
The clinical trial has a control group with parallel groups, randomized with software without blinding and a total sample size of 70 people and 35 people in each group.A simple randomization method was used with the help ofcomputer
Settings and conduct
Patients with breast cancer referred to Imam Reza Kermanshah Hospital who meet the inclusion criteria are randomly divided into two groups(Simple randomization with computer-aided random number table) the sample size is 70 people,(35person in each ) .The control groups received the physical activity protocol in written form and received training about it, while the intervention group exercised in a group with the same protocol in the designated place.
Participants/Inclusion and exclusion criteria
Having breast cancer;Completion of chemotherapy; Not taking drugs for anxiety disorders; Not suffering from other psychological and personality disorders; Age range from 15 to 50 years;contraindication for physical activity; Failure to simultaneously participate in other sports courses
Intervention groups
In this research, the exercise protocol includes a combined training course (aerobic-resistance) based on which the patients will participate in three sessions per week for 8 weeks.The control group will do physical activity at home individually and the intervention group will do physical activity in a group at the designated place. The experimental and control group performed concurrent training for eight
weeks (three days per week), including resistance training with 60-75 percent of a maximal repeat and aerobic
exercise with 60-75 percent of maximum heart rate.
Main outcome variables
Anxiety score with Beck questionnaire and quality of life score with QLQ-C30 questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230112057116N1
Registration date:2023-09-24, 1402/07/02
Registration timing:registered_while_recruiting
Last update:2023-09-24, 1402/07/02
Update count:0
Registration date
2023-09-24, 1402/07/02
Registrant information
Name
Peigham Heidarpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4156
Email address
pheidarpoormd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of physical activity at home with group physical activity in anxiety and quality of life of breast cancer patients
Public title
physical activity in breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
breast cancer patients
Completion of chemotherapy
Exclusion criteria:
Taking psychiatric and psychoactive drugs
Simultaneously participating in other sports courses, performing regular exercise and therapeutic interventions simultaneously with research
Physical problems that prevent physical activity ( such as musculoskeletal disorders), physical activity contraindication
Suffering from other psychological and personality disorders
Age
From 15 years old to 50 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
Simple individual randomization with a table of random numbers
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 commitee of school of medical education of shahid Beheshti University of medical sciences
Street address
Valiasr street
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-05-21, 1402/02/31
Ethics committee reference number
IR.SBMU.SME.REC.1402.027
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C00-C75
ICD-10 code description
C00-C75
Primary outcomes
1
Description
anxiety score based Beck questionnaire
Timepoint
pre and post intervention
Method of measurement
Beck anxiety questionnaire
2
Description
quality of life score
Timepoint
pre and post intervention
Method of measurement
quality of life of cancer patients(QLQ-C30)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: group physical activity
Category
Behavior
2
Description
Control group: individual physical activity in home
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imamreza hospital Kermanshah University of medical sciences
Full name of responsible person
Peigham Heidarpoor
Street address
Parastar street next to kermanshah medical school of
City
Kermanshah
Province
Kermanshah
Postal code
6742757333
Phone
+98 83 3427 6300
Fax
+98 83 3427 6300
Email
peigham.heidarpoor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
research and technology affair of Shahid Beheshti University of medical sciences