Comparing the Effect of Combined Decongestive Therapy with or without Resistive Exercises on Edema Volume, Upper Limb Function, and Quality of Life among Women with Breast Cancer Related Lymphedema
Comparing the Effect of Combined Decongestive Therapy with or without Resistive Exercises on Edema Volume, Upper Limb Function, and Quality of Life among Women with Breast Cancer Related Lymphedema
Design
Randomized controlled trial with control group, double blinded
Blocks of 4 will be used for randomization.
Settings and conduct
38 lymphedema patients in 2 groups will participate in this study. Both groups will be treated for 10 sessions.
The assesor and the patient will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with breast cancer who had undergone treatments
Cancer treatments finished at least 6 weeks ago
Native Iranians or people who can read and write persian
Patients with lymphedema diagnosis with one of these conditions: 1- At least 2 centimeters difference in upper limbs' circumference 2-At least 200 milliliters difference in upper limbs' volume 3- At least 5 percent difference in upper limbs' volume
Non inclusion criteria: Cancer recurrence
Uncontrolled infection
Untreated heart or kidney failure
Deep vein thrombosis in upper limb
Inability to participate in physiotherapy
Inability to understand commands
Uncontrolled hypertension
Inflammatory neuromuscular disease
Coronary artery disease
Congestive heart failure
Experiencing joint or muscle pain while doing active movements without resistence
Intervention groups
Control group: 10 sessions of combined decongestive therapy that consists of skin and nail care, manual lymph drainage, compression bandage and decongestive exercises.
Intervention group: 10 sessions of combined decongestive therapy and 6 sessions of concurrent resistive exercise
Main outcome variables
Limb volume; limb circumference; dexterity; upper limb function; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230816059172N1
Registration date:2023-09-13, 1402/06/22
Registration timing:prospective
Last update:2023-09-13, 1402/06/22
Update count:0
Registration date
2023-09-13, 1402/06/22
Registrant information
Name
Aisan Seyedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
seyyedia1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Combined Decongestive Therapy with or without Resistive Exercises on Edema Volume, Upper Limb Function, and Quality of Life among Women with Breast Cancer Related Lymphedema
Public title
Resistive exercise in lymphedema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with breast cancer who had undergone needed treatments
Patients who had finished their chemotherapy or radiotherapy at least 6 weeks ago
Native Iranians or people who can read and write persian
Patients with lymphedema diagnosis with one of these conditions: 1- At least 2 centimeters difference in upper limbs' circumference; 2-At least 200 milliliters difference in upper limbs' volume; 3- At least 5 percent difference in upper limbs' volume
Exclusion criteria:
Cancer recurrence
Untreated heart or kidney failure
People experiencing joint or muscle pain while doing active movements without resistence
Uncontrolled infection
Deep vein thrombosis in upper limb
Inflammatory neuromuscular disease
Coronary artery disease
Congestive heart failure
People who are unable to understand commands
People who are unable to participate in physiotherapy
Uncontrolled hypertension
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomized by block balance randomization. They will be sorted by blocks of 4 into two groups. Sequence of blocks will be made by Randomization website.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients will be unaware of their group allocation.
The assessor will be unaware of which group the participanthas been allocated.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
School of rehabilitation, Pich-e-Shemiran, Enghelab St، District 12, Tehran
City
Tehran
Province
Tehran
Postal code
65111-11489
Approval date
2023-08-16, 1402/05/25
Ethics committee reference number
IR.TUMS.FNM.REC.1402.117
Health conditions studied
1
Description of health condition studied
Breast cancer related lymphedema
ICD-10 code
I97.2
ICD-10 code description
Postmastectomy lymphedema syndrome
Primary outcomes
1
Description
Quality of life
Timepoint
Before starting the intervention and at the end of treatment period
Method of measurement
Lymphedema life impact scale questionnaire
2
Description
Upper limb function
Timepoint
Before starting the intervention and at the end of treatment period
Method of measurement
Performing Upper limb functional test and dexterity test
Secondary outcomes
1
Description
Upper limb circumference
Timepoint
Before starting the intervention and at the end of treatment period
Method of measurement
Measuring tape
2
Description
Upper limb volume
Timepoint
Before starting the intervention and at the end of treatment period
Method of measurement
Measuring tape and calculator
Intervention groups
1
Description
Intervention group: Combined decongestional therapy which consists of compression bandage, skin and nail care, manual lymph drainage and exercise therapy will be performed for 10 sessions and 5 days per week. The participants will also perform 6 sessions of resistive exercise concurrently.
Category
Treatment - Other
2
Description
Control group: Combined decongestional therapy which consists of compression bandage, skin and nail care, manual lymph drainage and exercise therapy will be performed for 10 sessions and 5 days per week.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences - School of Rehabilitation
Full name of responsible person
Aisan Seyedi
Street address
Tehran, District 12, Enghelab St، Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
seyyedia1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Tehran Province, Tehran, Keshavarz Blvd, P95V+4X7, Iran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 8899 2970
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Aisan Seyedi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of rehabilitation, Pich-e-Shemiran, Enghelab St، District 12, Tehran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Fax
Email
seyyedia1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aisan Seyedi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of rehabilitation, Pich-e-Shemiran, Enghelab St، District 12, Tehran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Fax
Email
seyyedia1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aisan Seyedi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of rehabilitation, Pich-e-Shemiran, Enghelab St، District 12, Tehran
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Fax
Email
seyyedia1@gmail.com
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
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only the information about outcome measures will be shared.
When the data will become available and for how long
8 months after publication of the results
To whom data/document is available
Researchers who are affiliated to medical universities
Under which criteria data/document could be used
Data could only be processed after seeking permission from researcers.
From where data/document is obtainable
1- Email: seyyedia1@gmail.com
2- Phone number 09128956585
What processes are involved for a request to access data/document
After sending the request and correspondence, data will be sent within 10 work days.