The objective of this study is to assess the effects of resistance exercise on pain and fatigue, mobility, and muscle mass preservation in breast cancer patients.
Design
Single blinded. Assessor will be unaware of the intervention (intervention or control).
status
This study is a randomized controlled trial
Participants will be assigned to either the intervention group (resistance exercise) or the control group (usual care) by computer generated
Baseline measurements of pain, fatigue, mobility and muscle mass will be recorded. At the midpoint of the intervention period pain, fatigue, mobility, and muscle mass will be reassessed for both groups. At the end of the 6-week intervention, final measurements of pain, fatigue, mobility, and muscle mass will be obtained for both groups.
Settings and conduct
Data will be collected from Shaukat khanum hospital, Lahore and oncology department at University of Lahore teaching hospital (ULTH).
Blinding
Single blinded.
Participants/Inclusion and exclusion criteria
INCLUSION
Age between 18 to 50 years.
Breast Cancer survivors.
Cancer survivors undergoing pain and moderate fatigue and had treatment with both chemotherapy and radiation therapies.
EXCLUSION
Recent orthopedic surgery.
Active infections in cancer patients of grade III-IV
Intervention groups
Group A: participants receive standard care in this group
Group B: participants receive resistance exercises with respect to their conditions
Main outcome variables
Visual Analog Scale
Multidimensional fatigue inventory questionnaire
Timed Up and Go (TUG) test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231103059935N1
Registration date:2023-11-25, 1402/09/04
Registration timing:prospective
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
Ayesha Javed
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 313 8633199
Email address
ayeshajavedrao@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-30, 1402/09/09
Expected recruitment end date
2024-01-15, 1402/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of resistance exercise on pain, fatigue and mobility in breast cancer survivors
Public title
Resistance exercise on pain, fatigue and mobility in breast cancer survivors `
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Breast Cancer survivors
• Cancer survivors undergoing pain and moderate fatigue
• Cancer survivors had treatment with both chemotherapy and radiation therapies
• Age between 18 to 50 years
Exclusion criteria:
• Recent orthopedic surgery.
• Active infections in cancer patients of grade III-IV i.e sepsis.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly allocated into two groups through computer generated list. Simple randomization. Unit of randomization is individual and tool used in randomization is sealed envelops. The use of sealed envelopes helps ensure that the treatment assignments are concealed until the last moment before the participant receives the treatment. This minimizes the risk of selection bias and ensures that the allocation process is not influenced by knowledge of upcoming assignments. The randomization process and envelope preparation are typically conducted by individuals who are not directly involved in participant enrollment or data collection to maintain the integrity of the study design.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blinded
Placebo
Not used
Assignment
Factorial
Other design features
Wall push-ups, Scapular squeeze, and Resistance bands exercises for resistance training
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of University of Lahore
Street address
1-Km Defence Road, near Bhuptian Chowk, Lahore, Punjab
City
Lahore
Postal code
54000
Approval date
2023-10-16, 1402/07/24
Ethics committee reference number
REC-UOL-544-10-2023
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
Pain
Timepoint
Before intervention ,3 and 6th weeks After intervention
Method of measurement
Visual analog scale
2
Description
Fatigue
Timepoint
Before intervention ,3 and 6th weeks after intervention
Method of measurement
Multidimensional fatigue inventory questionnaire
Secondary outcomes
1
Description
Mobility
Timepoint
Before intervention, 3 and 6 weeks after intervention
Method of measurement
Timed Up and Go (TUG) test
Intervention groups
1
Description
Intervention Group (Resistance Exercise): Participants will engage in a supervised resistance exercise program. Patient- tailored program of resistance exercise will be applied. The program will include a moderate to progressive series of resistance exercises targeting major muscle groups. Sessions will be conducted 2 times per week for 6 weeks. Each session will last 45 minutes, including warm-up, exercise, and cool-down. Exercise intensity and resistance will be adjusted based on individual capabilities and progress. Participants' pain, fatigue, and muscle mass will be closely monitored throughout the intervention.
Category
Rehabilitation
2
Description
Control Group (Standard Care): Participants will receive standard care, including medical treatments and recommendations provided by their healthcare providers. No specific exercise interventions will be introduced during the study period for this group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Lahore teaching hospital
Full name of responsible person
Dr. Asim Arif
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 321 6597727
Fax
+92 321 6597727
Email
asim.arif@uipt.uol.edu.pk
Web page address
https://uol.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Dr. Ashfaq Ahmed
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 300 6477662
Fax
+92 300 6477662
Email
ayeshajavedrao@gmail.com
Web page address
https://uol.edu.pk/
Grant name
nil
Grant code / Reference number
nil
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of Lahore
Proportion provided by this source
100
Public or private sector
Private
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
University of Lahore
Full name of responsible person
Ayesha javed
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
House no. 41, block C, Punjab government employees cooperative housing society, Phase 2, Lahore , Pakistan
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 313 8633199
Fax
+92 300 6477662
Email
ayeshajavedrao@gmail.com
Web page address
https://uol.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Ayesha javed
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
House no. 41, block C, Punjab government employees cooperative housing society, Phase 2, Lahore , Pakistan
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 313 8633199
Fax
+92 300 6477662
Email
ayeshajavedrao@gmail.com
Web page address
https://uol.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Ayesha javed
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
House no. 41, block C, Punjab government employees cooperative housing society, Phase 2, Lahore , Pakistan
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 313 8633199
Fax
+92 300 6477662
Email
ayeshajavedrao@gmail.com
Web page address
https://uol.edu.pk/
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
Demographic data and data related to final outcome will be shared by maintaining the confidentiality
When the data will become available and for how long
Data will be available from November 2024 to December 2024 after the 6 months of publication. The data sharing plan for a clinical trial( i.e. what data will be shared when and under what conditions)will be publicly available at a third-party site that shares data with and meets the data requirements of WHO's international clinical trail registry platform, this occur before the first participants is enrolled.
To whom data/document is available
Ayesha Javed( corresponding author) masters student at university of Lahore
Under which criteria data/document could be used
For research purpose
From where data/document is obtainable
To the corresponding author of the study, Dr. Ayesha Javed and can contact on +923006477662 ,ayeshajavedrao@gmail.com
What processes are involved for a request to access data/document
Open access and there is the traditional public data release where anyone can get access to the data with no registration or conditions. The request will be reviewed by director in charge and in case of eligibility, it would be shared in two weeks