IRCT | The Comparison between the effect of online and face to face resistance training with manual therapy and mobilization on pain, range of motion, lymphedema, depression, body image and shoulder function in breast cancer survivors.

Protocol summary

Study aim: The aim of this study is the Comparison of the effect of online and face to face resistance training with manual therapy and mobilization on pain, range of motion, lymphedema, depression, body image and shoulder function in breast cancer survivors.
Design: This research, because of two intervention group and one control group is quasi- experimental and clinical trial and research design is pre and post test, a blinded study and randomize control trial. 42 participants will be recruited and loss of participants will be 20%.
Settings and conduct: In this study, participants will be recruited from Gerash hospital with insert Announcement and they will be examined by physician. Before training process, participants will be assigned consent form. Eventually, after pre test experiment groups will be executed training self-specific protocol for six weeks and three sessions at per week, while control group will be continued to their routine activity daily live. It is saying that training protocol will be executed in Amirolmomenin gym.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Women that survive from breast cancer in 30 to 50 age. Lack of cardiovascular disease. 6 to 12 month after their surgery, Chemotherapy and Radiotherapy. Exit criteria: Smoking and alcohol usage. Disease recurrent and presence of injury during intervention process. 2 consecutive sessions or 3 interval session absence in training process. Lack of intention to taking part in thesis process.
Intervention groups: Group of online and in person resistance training with manual therapy ‏Group of mobilization
Main outcome variables: Pain, Range of motion, depression, lymphedema, body image and shoulder function

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20230415057913N1

Registration date: 2023-05-08, 1402/02/18

Registration timing: prospective

Last update: 2023-05-08, 1402/02/18

Update count: 0
Registration date: 2023-05-08, 1402/02/18

Registrant information: Name

Fereshteh Ghorbani

Name of organization / entity

Kharazmi University of Tehran

Country

Iran (Islamic Republic of)

Phone

+98 71 5244 0054

Email address

alifreshfrifit@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-05-11, 1402/02/21
Expected recruitment end date: 2023-07-12, 1402/04/21
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The Comparison between the effect of online and face to face resistance training with manual therapy and mobilization on pain, range of motion, lymphedema, depression, body image and shoulder function in breast cancer survivors.

Public title: The Comparison between the effect of online and face to face resistance training with manual therapy and mobilization on pain, range of motion, lymphedema, depression, body image and shoulder function in breast cancer survivors.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

• Women survived from breast cancer in 30 to 50 age. • Lack of cardiovascular disease. • 6 to 12 month past their surgery, Chemotherapy and Radiotherapy.

Exclusion criteria:

• Smoking and alcohol usage. • Disease recurrent and presence of injury during intervention process. • 2 consecutive sessions or 3 interval session absence in training process. • Lack of intention to taking part in thesis process.
Age: From 30 years old to 50 years old
Gender: Female

Phase

N/A

Groups that have been masked

Participant
Data analyser

Sample size

Target sample size: 42

Randomization (investigator's opinion)

Randomized

Randomization description

In this thesis, 42 participants will be recruited and They randomly assigned into a control group and two experimental group then, for randomization assignment, coding boxes with random order will be used so that, their size and forms are similar. This process is individually and sealed envelope will be used to randomization so that one number is assigned to a person. Number one will be assigned to resistance training +manual therapy group, number two will be assigned to mobilization group ,and number three will be assigned to control group.

Blinding (investigator's opinion)

Single blinded

Blinding description

In this research, participants will be divided into two experimental groups and a control group. At first, They will be informed about research process generally But, They will not informed about research details such as; objectives. In exert phases, the first and second intervention group will be separated then others. Data analysis will be implemented by statistic data analysis specialist so that he/she will be received statistical data.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Kharazmi Univercity.

Street address

Shahid Keshvari complex, South Razan st, Mirdamad Endway. Physical education and Sport Science Faculty, Tehran, Iran.

City

Tehran

Province

Tehran

Postal code

1587958711
Approval date: 2023-02-19, 1401/11/30
Ethics committee reference number: IR.SSRC.REC.1401.153

Health conditions studied

1

Description of health condition studied: Women who is survived from breast cancer
ICD-10 code: C50
ICD-10 code description: Malignant neoplasm of breast

Primary outcomes

1

Description: Pain
Timepoint: Pre and post test
Method of measurement: Visual Analog Scale

2

Description: Range of Motion
Timepoint: Pre and post test
Method of measurement: Goniometer

3

Description: Lymphedema
Timepoint: Pre and post test
Method of measurement: Lymphedema Volume meter

4

Description: Depression
Timepoint: Pre and post test
Method of measurement: Depression Test

5

Description: Body Image
Timepoint: Pre and post test
Method of measurement: Body Image Questionnaire

6

Description: shoulder function
Timepoint: Pre and post test
Method of measurement: Y Balance tes

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: In this study, the First intervention group (resistance training + manual therapy) will be executed 6 weeks and 3 sessions per week for 60 min integrated online and in person training. The researcher 1 session will be assigned 1 session to in person training and 2 sessions will be assigned to online training. In this thesis, resistance training will be executed by ACSM guideline included flexors, abductors and external rotators of upper body muscles strengthening. Warm up will be performed for 5 min after and before of training. Training in first and second week will be performed by 8 to 12 repetitions with 2 sets, training in third and fourth week by 8 to 12 repetitions with 3 sets and eventually, fifth and sixth week by 8 to 12 repetitions with 4 sets.
Category: Rehabilitation

2

Description: Intervention group: Second intervention group (manual therapy) will be executed 6 weeks mobilization with Dr. Dias protocol for scapula and shoulder joint. Thus, for prevention of lymphedema in breast, thorax anf other portions of included upper limb body, PNF and scar tissue massage will be executed orderly assist and passive movement and then, active and assist active movement with patients education.
Category: Rehabilitation

3

Description: Control group: the control group will not bee do any intervention.
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

The Gerash Amir All Momenin educational and Therapeutic Center.

Full name of responsible person

Fereshteh ghorbani

Street address

Baran Alley, Vahdat St, Sheikh Ahmed Ansari St, Gerash City, Iran.

City

Gerash

Province

Fars

Postal code

74417636840

Phone

+98 71 5244 0054

Email

alifreshfrifit@gmail.com

1

Sponsor: Name of organization / entity

Kharazmi university

Full name of responsible person

Amir Letafat Kar

Street address

Sport Science Faculty, Shahid Keshvari Complex, South Razan St, Mirdamad St

City

Karaj

Province

Tehran

Postal code

439815875

Phone

+98 21 2222 8001

Email

letafatkaramir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Kharazmi 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

Kharazmi University

Full name of responsible person

Fereshteh Ghorbani

Position

Mater of Student

Latest degree

Bachelor

Other areas of specialty/work

Sport Medicine

Street address

Baran Alley, Vahdat St, Sheikh Ahmed Ansari St, Gerash City, Fars United, Iran.

City

Gerash

Province

Fars

Postal code

7441763684

Phone

+98 71 5244 0054

Email

alifreshfrifit@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Kharazmi University

Full name of responsible person

Fereshteh Ghorbani

Position

Mater of Student

Latest degree

Bachelor

Other areas of specialty/work

Sport Medicine

Street address

Baran Alley, Vahdat St, Sheikh Ahmed Ansari St, Gerash City. Fars United, Iran.

City

Gerash

Province

Fars

Postal code

7441763684

Phone

+98 71 5244 0054

Email

alifreshfrifit@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Kharazmi University

Full name of responsible person

Fereshteh Ghorbani

Position

Mater of Student

Latest degree

Bachelor

Other areas of specialty/work

Sport Medicine

Street address

Baran Alley, Vahdat St, Sheikh Ahmed Ansari St, Gerash City, Fars Pronice, Iran..

City

Gerash

Province

Fars

Postal code

7441763684

Phone

+98 71 5244 0054

Email

alifreshfrifit@gmail.com

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: only a part of data as a mean is shard with a paper.
When the data will become available and for how long: September 2023
To whom data/document is available: The informatin is confidentional and available for all as a papar
Under which criteria data/document could be used: the informatin is confidentional and available for all as a papar
From where data/document is obtainable: Fereshteh ghorbani
What processes are involved for a request to access data/document: 2 months later of publish, data will be sent by email
Comments

The Comparison between the effect of online and face to face resistance training with manual therapy and mobilization on pain, range of motion, lymphedema, depression, body image and shoulder function in breast cancer survivors.