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Exercise Therapy During Radiotherapy

Primary Purpose

Breast Cancer, Exercise Therapy, Radiotherapy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise intervention
routine radiotherapy protokol
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Exercise therapy, Radiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients İn the age range of 18-65
  • Receiving radiotherapy to the axillary region after surgery with breast cancer diagnosis

Exclusion Criteria:

  • Radiotherapy area to contain only the chest wall
  • Any orthopedic injury or trauma involving the upper extremity prior to or during the cancer diagnosis
  • The presence of metastases in any area other than breast tissue

Sites / Locations

  • Dr. Abdurrahman Yurtaslan Onkoloji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

exercise intervention group

routine radiotherapy protocol

Arm Description

This group will be taken an exercise intervention during their radiotherapy programme.

This group will not be taken into an exercise intervention during their radiotherapy programme.

Outcomes

Primary Outcome Measures

Upper extremity functional status of patients during radiotherapy protocol
The subjective upper extremity functional status will assessed by The Disabilities of the Arm, Shoulder and Hand Score (DASH). This is 30 questions Questionnaire and 21 evaluate the person's difficulties during daily activities, 5 of them (pain, stiffness, tingling, weakness) and 4 of them evaluate work, sleep, social function and self-confidence. The person answers all questions according to the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: inability). A score of 0-100 is obtained from each section. As the score increases, the disability increases.
Shoulder joint range of motion (ROM) of patients during radiotherapy protocol
Shoulder range of motion in flexion, abduction, internal rotation and external rotation will be evaluated by the standard goniometer. Total Active and passive degree of ROM will be evaluated in patient sitting position. Total ROM will record in degree value.
Hand Grip force measurement of patients during radiotherapy protocol
Jamar hand dynamometer will be used for to evaluate gross hand grip force. While the patient is sitting with a back support in a comfortable seat, he will be asked to grasp the dynamometer with a gross grip at 90˚ flexion and compress it as strong as she can. 3 measurements will be made for both hands and the average of the values in kg will be recorded.

Secondary Outcome Measures

Fear of movement, avoidance reaction of patients during radiotherapy protocol
Tampa kinesiophobia ( fear of pain due to movement) scale will be used to evaluate the fear of movement degree. The survey has 17 question as a scale that is answered according to the 4-point Likert system. Total point will be between 17-68. As the score increases, the fear of movement increases.
Physical activity level of patients during radiotherapy protocol
It will be evaluated by a short version of the International Physical Activity survey. The questionnaire consists of 7 questions and has open-ended questions for the physical activities to be filled in by the patient for the duration of activity and number of days.
Pain and sensory impairment of patients during radiotherapy protocol
The McGill Pain short form scale will be used to evaluate patients sensory impairment. In the scale, 2 scores will be counted, first one is the total number of words defined by the person related to pain and sensation. Second score will be given by the patient to herself on visual analog scale in the range of 0-10. 10 means the worst pain while 0 is no pain.
Scapular dyskinesia of patients during radiotherapy protocol
Lateral Slide Test method will be used to measure the scapular dyskinesia. In this method; While the patient is in a standing position the bottom corner of the scapula will be marked and the perpendicular length to the nearest vertebra will be measured with the help of tape for both scapulae. Then the same measurement will be repeated while the hands are at the waist and the hands are held in the 90˚ abduction position. The difference in scapula movement for both sides will be noted in cm.
Upper extremity kinesthesia and shoulder joint position sensation of patients during radiotherapy protocol
While the patient's eyes closed and sitting on a chair, therapist's will be brought the shoulder range of motion to 90 degrees from the 0 degree start position. Meanwhile, angular value checks will be performed with an inclinometer fixed with velcro to mid-humeral area. A few seconds after the position is felt, the arm will be returned to the 0 degree start position. The patient will be asked to open his eyes and then he will be asked to actively bring his shoulder to the angle closest to the previous angle. Measurements will be made in 3 repetitions separately for the right and left sides and the degree differences will be determined for the sense of position and the average of the results will be taken.
Lymph edema evaluation of patients during radiotherapy protocol
The lymph edema measurement will be made with a tape. The circumferential length around the arm will be made in every 5 cm from the distal tubercle to the shoulder. Studies have explained that a difference of up to 2 cm between both extremities can be considered normal and moderate and excessive lymph edema classification according to the difference in measurement. According to this staging, the severity of lymph edema in patients will be determined and recorded.
Life quality of patients during radiotherapy protocol
It will be evaluated by EORTC QLQ-C30 (Cancer-specific quality of life index) . the questionnaire consists of 23 questions.The person answers all the questions according to the 4-point Likert system (1: none, 2: a little, 3: quite, 4: much). All sub scale points range between 0-100.
Breast cancer specific life quality of patients during radiotherapy protocol
It will be evaluated by EORTC QLQ-BR23 (Breast cancer-specific quality of life index). The questionnaire consists of 30 questions The person answers all the questions according to the 4-point Likert system (1: none, 2: a little, 3: quite, 4: much).All sub scale points range between 0-100.

Full Information

First Posted
August 4, 2020
Last Updated
February 8, 2021
Sponsor
Hacettepe University
Collaborators
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04507789
Brief Title
Exercise Therapy During Radiotherapy
Official Title
Investigation of the Effectiveness of Exercise Training During Radiotherapy in Postoperative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2020 (Actual)
Primary Completion Date
March 10, 2021 (Anticipated)
Study Completion Date
April 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
Collaborators
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The main purpose of our study is to investigate the effects of exercise therapy on upper extremity functions in patients receiving radiotherapy to the axillary region after breast cancer surgery.
Detailed Description
Our study will take in place in radiation oncology clinic. In routine the patients which will receive axillary area radiotherapy will randomized into 2 groups will explained in study arms section later. There are papers explained about radiotherapy side effects to upper extremity functions. But there is lack of evidence about exercise therapy during radiotherapy protocol to cope with its side effects to upper extremity functions. In this study we will compare two groups upper extremity function related outcomes at the end of the radiotherapy sessions and also before and after results for two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Exercise Therapy, Radiotherapy, Upper Extremity Problem
Keywords
Breast cancer, Exercise therapy, Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exercise intervention group
Arm Type
Experimental
Arm Description
This group will be taken an exercise intervention during their radiotherapy programme.
Arm Title
routine radiotherapy protocol
Arm Type
Active Comparator
Arm Description
This group will not be taken into an exercise intervention during their radiotherapy programme.
Intervention Type
Other
Intervention Name(s)
exercise intervention
Intervention Description
Exercise protocol will consist of the recommended special exercise sets for upper extremity problems on mastectomy patients. The upper extremity protocol has published in 2018 by Richmond and friends called prevention of musculoskeletal shoulder problems after breast cancer treatment UK-PROSPER protocol.this special protocol has unique exercise sets for to restore shoulder range of motion, to maintain good force level of upper extremity muscles and stretch exercises especially to the muscles around the radiotherapy area. Exercises will be done under the supervision of a specialized physiotherapist about upper extremity disorders.
Intervention Type
Other
Intervention Name(s)
routine radiotherapy protokol
Intervention Description
This intervention is only an observation to patients during their routine radiotherapy protocol. There will be no exercise intervention for the upper extremity for the patient in this group.
Primary Outcome Measure Information:
Title
Upper extremity functional status of patients during radiotherapy protocol
Description
The subjective upper extremity functional status will assessed by The Disabilities of the Arm, Shoulder and Hand Score (DASH). This is 30 questions Questionnaire and 21 evaluate the person's difficulties during daily activities, 5 of them (pain, stiffness, tingling, weakness) and 4 of them evaluate work, sleep, social function and self-confidence. The person answers all questions according to the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: inability). A score of 0-100 is obtained from each section. As the score increases, the disability increases.
Time Frame
''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Title
Shoulder joint range of motion (ROM) of patients during radiotherapy protocol
Description
Shoulder range of motion in flexion, abduction, internal rotation and external rotation will be evaluated by the standard goniometer. Total Active and passive degree of ROM will be evaluated in patient sitting position. Total ROM will record in degree value.
Time Frame
''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Title
Hand Grip force measurement of patients during radiotherapy protocol
Description
Jamar hand dynamometer will be used for to evaluate gross hand grip force. While the patient is sitting with a back support in a comfortable seat, he will be asked to grasp the dynamometer with a gross grip at 90˚ flexion and compress it as strong as she can. 3 measurements will be made for both hands and the average of the values in kg will be recorded.
Time Frame
''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Secondary Outcome Measure Information:
Title
Fear of movement, avoidance reaction of patients during radiotherapy protocol
Description
Tampa kinesiophobia ( fear of pain due to movement) scale will be used to evaluate the fear of movement degree. The survey has 17 question as a scale that is answered according to the 4-point Likert system. Total point will be between 17-68. As the score increases, the fear of movement increases.
Time Frame
''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Title
Physical activity level of patients during radiotherapy protocol
Description
It will be evaluated by a short version of the International Physical Activity survey. The questionnaire consists of 7 questions and has open-ended questions for the physical activities to be filled in by the patient for the duration of activity and number of days.
Time Frame
''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Title
Pain and sensory impairment of patients during radiotherapy protocol
Description
The McGill Pain short form scale will be used to evaluate patients sensory impairment. In the scale, 2 scores will be counted, first one is the total number of words defined by the person related to pain and sensation. Second score will be given by the patient to herself on visual analog scale in the range of 0-10. 10 means the worst pain while 0 is no pain.
Time Frame
''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Title
Scapular dyskinesia of patients during radiotherapy protocol
Description
Lateral Slide Test method will be used to measure the scapular dyskinesia. In this method; While the patient is in a standing position the bottom corner of the scapula will be marked and the perpendicular length to the nearest vertebra will be measured with the help of tape for both scapulae. Then the same measurement will be repeated while the hands are at the waist and the hands are held in the 90˚ abduction position. The difference in scapula movement for both sides will be noted in cm.
Time Frame
''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Title
Upper extremity kinesthesia and shoulder joint position sensation of patients during radiotherapy protocol
Description
While the patient's eyes closed and sitting on a chair, therapist's will be brought the shoulder range of motion to 90 degrees from the 0 degree start position. Meanwhile, angular value checks will be performed with an inclinometer fixed with velcro to mid-humeral area. A few seconds after the position is felt, the arm will be returned to the 0 degree start position. The patient will be asked to open his eyes and then he will be asked to actively bring his shoulder to the angle closest to the previous angle. Measurements will be made in 3 repetitions separately for the right and left sides and the degree differences will be determined for the sense of position and the average of the results will be taken.
Time Frame
''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Title
Lymph edema evaluation of patients during radiotherapy protocol
Description
The lymph edema measurement will be made with a tape. The circumferential length around the arm will be made in every 5 cm from the distal tubercle to the shoulder. Studies have explained that a difference of up to 2 cm between both extremities can be considered normal and moderate and excessive lymph edema classification according to the difference in measurement. According to this staging, the severity of lymph edema in patients will be determined and recorded.
Time Frame
''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Title
Life quality of patients during radiotherapy protocol
Description
It will be evaluated by EORTC QLQ-C30 (Cancer-specific quality of life index) . the questionnaire consists of 23 questions.The person answers all the questions according to the 4-point Likert system (1: none, 2: a little, 3: quite, 4: much). All sub scale points range between 0-100.
Time Frame
''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Title
Breast cancer specific life quality of patients during radiotherapy protocol
Description
It will be evaluated by EORTC QLQ-BR23 (Breast cancer-specific quality of life index). The questionnaire consists of 30 questions The person answers all the questions according to the 4-point Likert system (1: none, 2: a little, 3: quite, 4: much).All sub scale points range between 0-100.
Time Frame
''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients İn the age range of 18-65 Receiving radiotherapy to the axillary region after surgery with breast cancer diagnosis Exclusion Criteria: Radiotherapy area to contain only the chest wall Any orthopedic injury or trauma involving the upper extremity prior to or during the cancer diagnosis The presence of metastases in any area other than breast tissue
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DAMLAGÜL AYDİN ÖZCAN
Phone
+90 0312 3052525
Email
damlagulozcan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Güçlü Sezai Kılıçoğlu
Phone
+90 0312 3360909
Email
sezaikilicoglu1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YAVUZ YAKUT
Organizational Affiliation
Professor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Güçlü Sezai Kılıçoğlu
Organizational Affiliation
assistant doctor
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. Abdurrahman Yurtaslan Onkoloji Hospital
City
Ankara
State/Province
Yenimahalle
ZIP/Postal Code
06200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damlagül Aydin Özcan
Phone
0530 873 99 63
Email
damlagulozcan@gmail.com

12. IPD Sharing Statement

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