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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05720858
Other study ID # 2022/050
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 20, 2022
Est. completion date December 30, 2023

Study information

Verified date January 2023
Source Hasan Kalyoncu University
Contact Ramazan Cihad Yilmaz
Phone +905070364611
Email fzt.yilmaz.cihad@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine the effect of telerehabilitation-based aerobic exercises on upper extremity functionality, cognitive status and quality of life in patients with survival breast cancer.


Description:

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Study Design


Intervention

Other:
Aerobic exercise
Reciprocal straight leg lift, Reciprocal hip knee flexion-extension, Lateral spinal rotation (Spinal rotation), Bridge Exercise, Elbow winging, Hip abduction, trunk extension, Shoulder elevation, Shoulder circulation, Shoulder flexion and extension, Shoulder abduction adduction, Reciprocal lateral trunk flexion and extension, Puching exercise, Mini Squat exercise, Reaching upward with hands reciprocally, Scapular adduction (Hands at waist), Push-ups on the wall, Knee Touch exercise, Arm Circles exercise, Reaching for feet in sitting position, Saw (The saw) exercise.

Locations

Country Name City State
Turkey Ramazan Cihad Yilmaz Gaziantep

Sponsors (1)

Lead Sponsor Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) The EORTC-QLQ-C30 Quality of Life Scale includes 30 questions and three subheadings: general well-being, functional difficulties, and symptom control. The first 28 of the 30 items in the scale are a four-point Likert-type scale and the items are evaluated as Never: 1, A little: 2, Quite: 3 or A lot: 4 points. In the 29th question of the scale, the patient is asked to evaluate his health on a scale from 1 to 7 (1: Very poor and 7: Excellent), and in the 30th question, the general quality of life. The 29th and 30th questions constitute the general well-being area. High scores in this section indicate a high quality of life, and low scores indicate a decrease in quality of life. (Hospital group, telerehabilitation group and control group will be evaluated) A day before the treatment
Primary Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) This form evaluates the parameters of cognitive sensitivity (sharpness), attention and coordination, memory, verbal fluency, functional confusion, observations of others about the individual, change in functionality compared to before, and quality of life. It consists of 4 subtitles and 37 questions in total. Questions in the sections of perceived cognitive impairment, comments from other people, perceived cognitive skills, and impact on quality of life are scored between 0 and 4 (0-several times per day times, 4-never). In 9 questions in the field of perceived cognitive skills, the score calculation is evaluated as 0-none, 4-too much. Perceived cognitive disorders and perceived cognitive skills subsections contain opposite questions and the last 2 questions are not included in the scoring. The increase in the total score indicates the goodness of the situation in terms of cognitive functions.(Hospital group, telerehabilitation group and control group will be evaluated) A day before the treatment
Primary Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire The Arm, Shoulder and Hand Injuries Questionnaire (DASH) will be used to evaluate the functions of the upper extremities.This questionnaire assesses disability, activity limitations, restriction on leisure activities and participation in work. The DASH questionnaire consists of three parts. The first part consists of 30 questions. 21 questions determine the patient's difficulty during activities of daily living, five questions determine the symptoms (pain, activity-related pain, tingling, stiffness, weakness), each of the remaining four questions determine the social function, work, sleep and the patient's function /symptom score.(Hospital group, telerehabilitation group and control group will be evaluated) A day before the treatment
Secondary Chronic Disease Treatment Functional Assessment Fatigue (FACIT Fatigue) Scale It is a measurement tool that subjectively evaluates the fatigue in the last week and consists of 13 expressions. The scale has a five-point Likert scale of 0 = not at all, 1 = very little, 2 = a little, 3 = a lot, and 4 = a lot. 11 items (1-6, 9-13) of the scale contain reverse expressions. The 7th and 8th items of the scale are calculated flat. The scores that can be obtained from the scale range from 0 to 52. A high total score on the scale indicates that the severity of fatigue is low. It is reported that the perception fatigue is clinically severe if the score from the scale is 30 or less. (Hospital group, telerehabilitation group and control group will be evaluated) Baseline, 6 weeks, 12 weeks, and 6 months
Secondary EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) The EORTC-QLQ-C30 Quality of Life Scale includes 30 questions and three subheadings: general well-being, functional difficulties, and symptom control. The first 28 of the 30 items in the scale are a four-point Likert-type scale and the items are evaluated as Never: 1, A little: 2, Quite: 3 or A lot: 4 points. In the 29th question of the scale, the patient is asked to evaluate his health on a scale from 1 to 7 (1: Very poor and 7: Excellent), and in the 30th question, the general quality of life. The 29th and 30th questions constitute the general well-being area. High scores in this section indicate a high quality of life, and low scores indicate a decrease in quality of life. (Hospital group, telerehabilitation group and control group will be evaluated) 6 weeks, 12 weeks, and 6 months
Secondary Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) This form evaluates the parameters of cognitive sensitivity (sharpness), attention and coordination, memory, verbal fluency, functional confusion, observations of others about the individual, change in functionality compared to before, and quality of life. It consists of 4 subtitles and 37 questions in total. Questions in the sections of perceived cognitive impairment, comments from other people, perceived cognitive skills, and impact on quality of life are scored between 0 and 4 (0-several times per day times, 4-never). In 9 questions in the field of perceived cognitive skills, the score calculation is evaluated as 0-none, 4-too much. Perceived cognitive disorders and perceived cognitive skills subsections contain opposite questions and the last 2 questions are not included in the scoring. The increase in the total score indicates the goodness of the situation in terms of cognitive functions.(Hospital group, telerehabilitation group and control group will be evaluated) 6 weeks, 12 weeks, and 6 months
Secondary Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire The Arm, Shoulder and Hand Injuries Questionnaire (DASH) will be used to evaluate the functions of the upper extremities.This questionnaire assesses disability, activity limitations, restriction on leisure activities and participation in work. The DASH questionnaire consists of three parts. The first part consists of 30 questions. 21 questions determine the patient's difficulty during activities of daily living, five questions determine the symptoms (pain, activity-related pain, tingling, stiffness, weakness), each of the remaining four questions determine the social function, work, sleep and the patient's function /symptom score.(Hospital group, telerehabilitation group and control group will be evaluated) 6 weeks, 12 weeks, and 6 months
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