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Reliability and Validity of The '6 Minute Pegboard and Ring Test' in Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT05258344
Recruitment Status : Recruiting
First Posted : February 28, 2022
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
Ebru Calik Kutukcu, Hacettepe University

Brief Summary:
Breast cancer is one of the most common cancers among women in the world and its incidence reaches up to 16%.Although survival can be increased with early diagnosis and more effective therapies, physical complications such as lymphedema, upper extremity dysfunction and chronic pain are frequently seen during and/or after breast cancer treatments. It has been determined that lymphedema associated with breast cancer treatment is a factor that mediates and/or exacerbates the adverse effects of breast cancer treatments on upper extremity functional capacity and quality of life of patients.It was determined that the 6 Minute Pegboard and Ring Test (6PRT) score showed a clear relationship with the upper extremity daily living activities (ADLs), and it was concluded that the 6 Minute Pegboard and Ring Test (6PRT) test could be used as an appropriate test in pulmonary rehabilitation programs to predict and show the improvement of daily living activities (ADLs). Therefore, in this study; The results to be obtained by evaluating the validity and reliability of the 6 Minute Pegboard and Ring Test (6PRT) test in breast cancer patients will increase the use of this test in both testing arm endurance and arm exercise capacity in breast cancer patients, and predicting the effect on daily living activities (ADLs)

Condition or disease
Breast Cancer Functional Performance Upper Extremity

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of the Reliability and Validity of The '6 Minute Pegboard and Ring Test' Unsupported Arm Function Exercise Test in Patients With Breast Cancer
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : January 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. 6 minute Pegboard and Ring Test - 6PRT [ Time Frame: one year ]
    Total number of rings installed within six



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients between the ages of 18-80 who were diagnosed with breast cancer in Hacettepe University Hospital, Department of Internal Medicine, Department of Medical Oncology and volunteered to participate in the study will be included in the study.
Criteria

Inclusion Criteria:

  1. To be between the ages of 18-80,
  2. Volunteering to participate in the research,
  3. At least 15 months after breast cancer surgery,
  4. 6 months after active breast cancer treatment (ie surgery/chemotherapy)
  5. Having no problem in reading and/or understanding the scales and being able to cooperate with the tests.

Exclusion Criteria:

  1. Presence of active infection,
  2. Presence of bilateral breast cancer,
  3. Presence of a history of surgical, neurological or orthopedic problems that may affect upper extremity functionality other than breast cancer surgery,
  4. Having a neurological disease or other clinical diagnosis that may affect cognitive status,
  5. Having musculoskeletal and neurological disease, symptomatic heart disease, previous lung surgery and malignant disease that may affect exercise performance.
  6. Presence of unstable hypertension or diabetes mellitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05258344


Contacts
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Contact: Ebru Calik Kutukcu, PhD +903123051576 ext 195 ebru.calik@hacettepe.edu.tr
Contact: Naciye Vardar-Yagli, PhD +03123051576 ext 129 naciyevardar@yahoo.com

Locations
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Turkey
Hacettepe University Recruiting
Ankara, State, Turkey, 06100
Contact: Ebru Çalık Kutukcu, Phd    0903123051576    ebrucalk85@hotmail.com   
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Ebru Calik Kutukcu, PhD Hacettepe University
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Responsible Party: Ebru Calik Kutukcu, Associate Professor, Hacettepe University
ClinicalTrials.gov Identifier: NCT05258344    
Other Study ID Numbers: GO 22/41
First Posted: February 28, 2022    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ebru Calik Kutukcu, Hacettepe University:
breast cancer
6 Minute Pegboard and Ring Test
Arm exercise endurance
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases