Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04618120
Other study ID # 2407471012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 22, 2017
Est. completion date March 2, 2019

Study information

Verified date November 2020
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to compare two different exercise approaches during the radiotherapy period in patients who have undergone breast cancer surgery.


Description:

Exercise therapies are effective methods in the treatment of complications after breast cancer surgery. The study aims to compare exercise practices with virtual reality-based exercise training during radiotherapy period after breast cancer surgery. Patients were randomly divided into 3 groups as virtual reality group, exercise group, and control group, considering the order of arrival at the clinic and the type of surgery (mastectomy and breast-conserving surgery). Patients in virtual reality group received virtual reality-based exercise training using Microsoft Xbox 360 Kinect (Redmond, WA). Patients in exercise group received an exercise program including range of motion, posture, stretching and breathing exercises. Both exercise groups participated in the exercise program for 30- 40 minutes, 3 days a week, as long as radiotherapy continued (5-6 weeks). Patients in the control group did not receive any exercise intervention as is done in the current practice. Assessment methods were applied at the beginning and at the end of the radiotherapy for all groups. Shoulder range of motion was measured using universal goniometer. Hand grip strength was measured using Jamar hand dynamometer. Shoulder proprioception was measured using Cybex (Lumex,NY,USA) isokinetic dynamometer. Upper extremity functional status, kinesiophobia, anxiety and depression level, fatigue and quality of life were evaluated with various questionnaires.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date March 2, 2019
Est. primary completion date January 2, 2019
Accepts healthy volunteers No
Gender Female
Age group 28 Years to 70 Years
Eligibility Inclusion Criteria: - Being over 18 years old - Being literate - Having a diagnosis of unilateral breast cancer - Having undergone surgery for breast cancer - Radiotherapy will be applied for breast cancer treatment. Exclusion Criteria: - Metastasis - Have an active infection - Having a cardiac or neurological disease that would prevent participation in the study - Having uncontrolled hypertension - Having an orthopedic disorder that prevents exercise - Having sensory or cognitive impairments that interfere with communication

Study Design


Intervention

Other:
Virtual reality-based exercise
Virtual reality-based exercises with "Microsoft Xbox 360 Kinect" and breathing exercises. Patient education
Exercise
Shoulder range of motion, stretching, posture and breathing exercises. Patient education

Locations

Country Name City State
Turkey Gazi University Faculty of Health Sciences Ankara Emek

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the shoulder range of motion Universal Goniometer Baseline and after the exercise training (5-6 weeks)
Primary Change in the grip strength assessed by hydraulic hand dynamometer Jamar Hydraulic Hand Dynamometer Baseline and after the exercise training (5-6 weeks)
Primary Change in the shoulder proprioception assessed by isokinetic dynamometer Cybex 770 Norm isokinetic dynamometer (Lumex Inc. NY,USA) Baseline and after the exercise training (5-6 weeks)
Primary Change in circumference of upper extremities Lymphedema circumference measurement Baseline and after the exercise training (5-6 weeks)
Primary Change in the functionality of upper extremities assessed by the Disability of Arm, Shoulder and Hand Questionnaire The Turkish version of the Disability of Arm, Shoulder and Hand Questionnaire is used to evaluate functional status of upper extremities. The questionnaire consists of 30 questions. A score between 0-100 is obtained from the questionnaire. 0 point means "no disability", 100 point means "maximum level of disability". Baseline and after the exercise training (5-6 weeks)
Primary Change in kinesiophobia assessed by theTampa Kinesiophobia Scale The Turkish version of theTampa Kinesiophobia Scale was used to determine the level of kinesiophobia. 4-point Likert scoring (1 = Strongly disagree, 4 = Strongly agree) is used in the scale. After reversing items 4, 8, 12 and 16, a total score is calculated. A score between 17-68 is obtained from the scale. The higher scores indicate higher kinesiophobia level. Baseline and after the exercise training (5-6 weeks)
Primary Change in anxiety and depression level assessed by the Hospital Anxiety and Depression Scale The Turkish version of the Hospital Anxiety and Depression Scale was used to determine the anxiety and depression level. The scale consists of 14 questions in total. 7 of the questions measure depression, 7 measure anxiety. A total score between 0-42 is obtained from the sum of the anxiety and depression scores. The higher scores indivate higher depression and /or anxiety. Baseline and after the exercise training (5-6 weeks)
Primary Change in fatigue assessed by Piper Fatigue Scale The Turkish version of Piper Fatigue Scale was used to determine the level of fatigue. The scale consists of 22 items (0-10 points) and 4 subscales: behavioral/severitiy (6 items), affective meaning (5 items), sensory (5 items) and cognitive/mood (6 items). Each subscale is scored individually and then aggregated together for an overall score. Higher scores indicate more fatigue.
As a result of the average score; 0 points are interpreted as no fatigue, 1-3 points mild fatigue, 4-6 points moderate fatigue, 7-10 points severe fatigue.
There are also 5 more questions in the scale that are not used in the subscale or total score calculation. These open-ended questions are about the duration of perceived fatigue, its causes, methods to alleviate fatigue and associated symptoms. They provide qualitative data.
Baseline and after the exercise training (5-6 weeks)
Primary Change in quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) The Turkish version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was used to evaluate quality of life level. It contains five functioning scales (physical, social, role, cognitive, and emotional functioning), eight symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbances, appetite loss, constipation, and diarrhea), financial impact, and overall quality of life. All scale scores are converted to range from 0 to 100. higher scores indicate better functioning for the functioning scales and overall quality of life; higher scores indicate higher symptom burden for the symptom scales. Baseline and after the exercise training (5-6 weeks)
Secondary Patient Satisfaction The motivation of the exercises, the state of enjoying the exercise, believing that the exercise is beneficial, and the patient's willingness to continue the exercise were evaluated with 4 questions that they could answer with Likert-type answers. Patient satisfaction was evaluated at the end of the 5-6 week exercise training.
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A