Exercise Therapy During Radiotherapy

NCT04507789 | Unknown

• 1 other identifier: 2020-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Exercise Therapy; Radiotherapy; Upper Extremity Problem

Keywords

Breast cancer; Exercise therapy; Radiotherapy

Outcome Measures

Primary Outcomes (3)

• 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.

  ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''

• 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.

  ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''

• 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.

  ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''

Secondary Outcomes (8)

• Fear of movement, avoidance reaction of patients during radiotherapy protocol

  ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''

• Physical activity level of patients during radiotherapy protocol

  ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''

• Pain and sensory impairment of patients during radiotherapy protocol

  ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''

• Scapular dyskinesia of patients during radiotherapy protocol

  ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''

• Upper extremity kinesthesia and shoulder joint position sensation of patients during radiotherapy protocol

  ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''

Study Arms (2)

exercise intervention group

EXPERIMENTAL

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

Other: exercise intervention

routine radiotherapy protocol

ACTIVE COMPARATOR

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

Other: routine radiotherapy protokol

Interventions

exercise intervention OTHER

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.

exercise intervention group

routine radiotherapy protokol OTHER

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.

routine radiotherapy protocol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead
• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: collaborator

Study Sites (1)

Dr. Abdurrahman Yurtaslan Onkoloji Hospital

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• YAVUZ YAKUT

  Professor

  STUDY CHAIR

• Güçlü Sezai Kılıçoğlu

  assistant doctor

  STUDY CHAIR

Central Study Contacts

DAMLAGÜL AYDİN ÖZCAN

CONTACT

+90 0312 3052525; damlagulozcan@gmail.com

Güçlü Sezai Kılıçoğlu

CONTACT

+90 0312 3360909; sezaikilicoglu1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 11, 2020
• Study Start: October 10, 2020
• Primary Completion: March 10, 2021
• Study Completion: April 10, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

TU (1)