The Effect of Aerobic Exercise Based Telerehabilitation Program on Upper Extremity Functıonality, Cognitive Status and Quality of Life in Patients With Survival Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire)
研究概览
简要总结
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.
详细描述
Early detection of breast cancer and advances in treatment methods have led to an increase in survival after diagnosis. The prolongation of survival from breast cancer necessitated addressing the physical and psychosocial needs of individuals who have completed the active treatment process. Survival period breast cancer patients, need rehabilitation due to the delayed effects of treatment and difficulties encountered in everyday life. In the literature, the importance of exercise is emphasized in order to combat these problems. Physical activity levels are generally low in survival breast cancer patients, and many women reduce physical activity after diagnosis. Therefore, interventions are necessary to improve physical activity activity levels in breast cancer patients of the survival period.
In order to improve the physical activity levels of these patients, exercises can be performed in the hospital and at home. However, there may be problems in terms of adherence to exercise in interventions performed in the form of home exercise. That is why the importance of face-to-face, supervised exercises is reported in the literature. Supervised exercise can be offered in the hospital and in the form of telerehabilitation.
Telerehabilitation is considered as a promising alternative to conventional clinical rehabilitation programs by providing participation and transportation in health interventions. The simplest telerehabilitation system is used through video conferencing, in such a way that the therapist can monitor the patient remotely with the help of a camera. Telerehabilitation can be a valuable alternative education mode for patients who can manage technology at home but are unable or unwilling to participate in centre-based rehabilitation programs.
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.
Hypothesis 1: Aerobic-based telerehabilitation approach improves upper extremity functionality more than hospital-based exercise in surviving breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 and 65
- •Having a diagnosis of breast cancer stage 1-2
- •Complete breast cancer primary treatment at least 6 months before (excluding hormone therapy/aromatase inhibitors)
- •Providing the cooperation
- •Physically inactive (60 minutes of structured exercise per week <)
- •Patients willing and voluntarily to participate in the study
排除标准
- •Who are using one of the psychotic, anxiolytic, antidepressant, analgesic and sleeping pills
- •With metastases
- •Those with a history of lymphedema
- •With neurological disease
- •Those who are pregnant or breastfeeding
- •Uncontrolled hypertensive patients
- •Those incapable of verbal communication or physical movement
- •Patients who did not agree to participate in the study
研究组 & 干预措施
Hospital group
A total of 36 sessions (3 days a week) will be applied. Training intensity will be performed at the level of 4-6 according to the modified Borg scale, and rest will be allowed between exercises according to the tolerance of the patients. In the hospital-based group, a supervised aerobic exercise program will be applied in the hospital. There will be warm-up exercises before the exercise and cool-down exercises after. At the beginning of the session, warm-up exercises will begin. Flexibility exercises will be applied during the warm-up period. Warm-up and cool-down exercises will be performed for 10 minutes with 3 repetitions, including the upper and lower extremities and distal joints. Exercises will be performed for 3 months, with 10 repetitions in the first 6 weeks and 15 repetitions in the next 6 weeks.
干预措施: Aerobic exercise (Other)
Telerehabilitation group
A total of 36 sessions (3 days a week) will be applied. Training intensity will be performed at the level of 4-6 according to the modified Borg scale, and rest will be allowed between exercises according to the tolerance of the patients. Supervised sessions will be held with the telerehabilitation group via phone or computer video conference (For patients who agree to participate, the physiotherapist will initially conduct the first session face-to-face).
There will be warm-up exercises before the exercise and cool-down exercises after. At the beginning of the session, warm-up exercises will begin. Flexibility exercises will be applied during the warm-up period. Warm-up and cool-down exercises will be performed for 10 minutes with 3 repetitions, including the upper and lower extremities and distal joints. Exercises will be performed for 3 months, with 10 repetitions in the first 6 weeks and 15 repetitions in the next 6 weeks.
干预措施: Aerobic exercise (Other)
Control group
They will continue their routine activities. After the study, those who wish will be included in the exercise program.
结局指标
主要结局
EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire)
时间窗: A day before the treatment
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)
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
时间窗: A day before the treatment
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)
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
时间窗: A day before the treatment
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)
次要结局
- Chronic Disease Treatment Functional Assessment Fatigue (FACIT Fatigue) Scale(Baseline, 6 weeks, 12 weeks, and 6 months)
- EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire)(6 weeks, 12 weeks, and 6 months)
- Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)(6 weeks, 12 weeks, and 6 months)
- Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire(6 weeks, 12 weeks, and 6 months)
研究者
Ramazan Cihad Yılmaz
lecturer
Hasan Kalyoncu University