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The effect of combined decongestive therapy with and without Pilates exercise on the expression of inflammatory biomarkers and body measurement in breast patients with upper extremity lymphedema

Protocol summary

Study aim
This trial aimed to explore the effect of combined decongestive therapy and Pilates exercise on expression of CA15-3 antigen, edema volume, shoulder range of motion and quality of life in breast cancer patients with unilateral upper extremity lymphedema.
Design
This clinical trial, conducted randomly on 30 patients. there were 15 people in the control group and 15 people in the intervention group.
Settings and conduct
Patients referring to a Lymphedema clinic in Tehran were included. First, patients were requested to participate in this study. If they were agreed, then they were assessed for eligibility criteria. Then, one who was in charge of randomization was called to allocate patients to control or intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with unilateral lymphedema, stage II patients without history of using complete decongestive therapy having no regular exercise during the last six month, menopausal woman, no infection in the arm and no severe skin redness, no taking anticoagulants, no nerve injuries in the upper extremity, no history of heart failure, no history of kidney disease, no paralysis in the hand or arm, no cancer recurrence.
Intervention groups
In control group, a total of 21 sessions of combined decongestive therapy were performed daily. Each session consisted of 40 minutes. Appropriate skin care methods including moisturizing and using multi-layered short stretch bands were used. In intervention group, in addition to combined decongestive therapy, patients had exercise for 6 weeks (5 days weekly) for 40-30 minutes. 10 warm-up exercise and then the main movements were performed with purpose of strengthening the muscles of hands and shoulders.
Main outcome variables
Inflammatory biomarkers and peykometry

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200421047158N1
Registration date: 2021-01-07, 1399/10/18
Registration timing: retrospective

Last update: 2021-01-07, 1399/10/18
Update count: 0
Registration date
2021-01-07, 1399/10/18
Registrant information
Name
Roghaya Mokhtari hesari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 5223 5720
Email address
r.hesari1353@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-30, 1399/03/10
Expected recruitment end date
2020-07-31, 1399/05/10
Actual recruitment start date
2020-05-30, 1399/03/10
Actual recruitment end date
2020-07-31, 1399/05/10
Trial completion date
2020-10-21, 1399/07/30
Scientific title
The effect of combined decongestive therapy with and without Pilates exercise on the expression of inflammatory biomarkers and body measurement in breast patients with upper extremity lymphedema
Public title
Exploring the effect of combined decongestive therapy and Pilates exercise on the reduction of lymphedema symptom
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with unilateral lymphedema, stage II Patients without history of using complete decongestive therapy Having no regular exercise during the last six month Menopausal women No infection in the arm and no severe skin redness Not taking anticoagulants No nerve injuries in the upper extremity No history of heart failure No history of kidney disease No paralysis in the hand or arm No cancer recurrence
Exclusion criteria:
Age
From 47 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In present study, simple randomisation method is used. Using random number table, we selected first number randomly. If the selected number is between 0 and 5, we allocated the subject to intervention group (group A) and when the number is between 6 and 9, patients were allocated to control group (group B).This process was continued to recruit 30 patients.
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
Sport science Research Institute
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2020-10-18, 1399/07/27
Ethics committee reference number
IR.SSRC.REC.1399.085

Health conditions studied

1

Description of health condition studied
Breast cancer related Lymphedema
ICD-10 code
I89.0
ICD-10 code description
Lymphedema, not elsewhere classified

Primary outcomes

1

Description
Quality of life
Timepoint
Three times: before study, after interventions and one month after treatment and exercise.
Method of measurement
Quality of life questionnaire; SF-36

2

Description
The expression of CA-153
Timepoint
48 hours before the intervention and at the end of the study
Method of measurement
ELISA Kit

Secondary outcomes

1

Description
The edema volume
Timepoint
Three times: 48 hours before the intervention, at the end of the study and one month after the intervention
Method of measurement
Volumetric cylinder or volumetric tank or volumetric meter

2

Description
Shoulder range of motion
Timepoint
Three times: 48 hours before the intervention, at the end of the study and one month after the intervention
Method of measurement
Goniometer

Intervention groups

1

Description
Intervention group: The standard decongestant treatment method combined with selected pilates training was performed for 6 weeks and 5 days per week for 30-40 minutes. warm up exercises included 10 minutes of breathing exercises then the main movements were performed aiming at strengthening arm and shoulder muscles containing rest intervals, thus the exercises continued until fatigue which included 7 exercises in one to three sets for 20 minutes. At the end, stretching and body cooling exercises were performed for 5 minutes.
Category
Rehabilitation

2

Description
Control group: Patients in the control group received standard combined decongestive therapy involves manual drainage of lymph nodes which was performed daily (5 days a week) for 3 weeks for a total of 21 sessions. Each session consisted of 40 minutes of manual drainage of lymph nodes, performed by a trained therapist. Appropriate skin care methods were used, including moisturizing as well as using multi-layered short stretch bands. Baby oil was used as a lotion.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Lymphedema Clinic (private sector)
Full name of responsible person
Dr. Zahra Sheikhi
Street address
Unit 2, No. 1, Shariati St
City
Tehran
Province
Tehran
Postal code
1941911371
Phone
+98 21 7763 0356
Email
Dr.shaikhi88@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hassan Rasooli Saghai
Street address
Islamic Azad University, Tabriz Branch, Pasdaran Expressway, Tabriz, East Azerbaijan Province
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3331 8681
Email
h_rasooli@iaut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Roghaye Mokhtari Hesari
Position
Non-faculty
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 30, Saadi 6, Andisheh
City
Miyane
Province
East Azarbaijan
Postal code
5315948331
Phone
+98 41 5223 5720
Email
r.hesari1353@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Roghaye Mokhtari Hesari
Position
Non-faculty
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 30, Saadi 6, Andisheh
City
Miyane
Province
East Azarbaijan
Postal code
5315948331
Phone
+98 41 5223 5720
Email
r.hesari1353@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Roghaye Mokhtari Hesari
Position
Non-faculty
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 30, Saadi 6, Andisheh
City
Miyane
Province
East Azarbaijan
Postal code
5315948331
Phone
+98 41 5223 5720
Email
r.hesari1353@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After removing all variables related to identification of patients, the data would be shared. Patients has completed the consent from. data related to primary and secondary outcomes would be accessible.
When the data will become available and for how long
6 months after the publication of the first article in reputable journals, data will be available.
To whom data/document is available
The data will be provided to help researchers in their investigations as well as to inform patients about their condition
Under which criteria data/document could be used
Researchers can use the data of this study in their studies to conduct new studies. It will also be provided to patients in order to be aware of their condition.
From where data/document is obtainable
Roghayeh Mokhtari Hessari, PhD student in sports physiology Phone: 09145884100 Email r.hesari 1353@gmail.com
What processes are involved for a request to access data/document
The request for data will be reviewed with the authors and contributors of the project and will be made available to others while maintaining ethical protocols.This process might take up to one month.
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