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临床试验/NCT04979715
NCT04979715已完成不适用

The Effect of Early Rehabilitation After Breast Cancer Surgery on Physical and Psychosocial Functions

Pamukkale University2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
2
主要终点
muscle shortness test

研究概览

简要总结

At least 42 patients between the ages of 30-65, who were followed up in Pamukkale University General Surgery Breast Polyclinic and planned for breast surgery, will be included in the study. Those who met the criteria for inclusion in the study and those who voluntarily agreed to participate in the study, who were preoperatively evaluated, will be randomly divided into two groups using the closed envelope method by matching age, gender, type of surgery and breast cancer stage. The first of these groups is the study (n=21) and the second is the control group (n=21).

详细描述

Study group: Patients in the study group will be informed about the postoperative physiotherapy program and patient education will be provided by the physiotherapist before the operation. After obtaining the consent of the surgeon performing the operation, preoperative and post-operative complications (infection, lymphedema, fatigue...) and the things to be considered (use of upper extremities, skin care, importance of weight control...) and patient education will be given by the physiotherapist. In addition, respiratory control, diaphragmatic breathing, relaxation exercises, gradual passive-active assistive-active range of motion exercises, stretching exercises will also be demonstrated preoperatively.

From the first postoperative day, with the approval of the surgeon performing the operation, the postoperative exercise program will be started once a day under the supervision of a physiotherapist during the stay of the participants in the hospital.

At the same time, participants will be directed to moderate intensity aerobic exercise (walking, jogging...) for 150 min/week. Information will be given on the importance of physical activity and increasing the level of physical activity. In addition, a brochure containing explanatory information about the postoperative physiotherapy program after breast surgery will be given to the participants.

Participants will continue the exercises as a home program after discharge. During this follow-up period, the participants will meet again with the physiotherapist every two weeks for the control, compliance and continuity of the exercises. In these interviews, while compliance with the exercise program is checked, exercise tolerance will also be determined and necessary interventions and modifications will be made. In case of any complication (limitation in physical functions, lymphedema...) during the home program, he will be informed about meeting with the relevant physician and physiotherapist as soon as possible.

Control group: The patients in the control group will be informed about the postoperative physiotherapy program and patient education will be provided by the physiotherapist before the operation. Within the knowledge and approval of the surgeon performing the operation, preoperatively, respiratory control, diaphragmatic breathing, relaxation exercises, passive-active assistive-active range of motion exercises are shown by the physiotherapist, and patient education is provided with information about possible postoperative complications and what needs to be considered. will be given.

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)

盲法说明

participants do not know which group they belong to

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Having a breast surgery indication with a diagnosis of breast cancer
  • Having stage 1-2-3 breast cancer
  • Education level to be at least literate
  • To be in stable clinical condition
  • Not having any other disease that will affect their physical and psychosocial functions
  • Being good at cooperation
  • Referred by the relevant surgeon and no contraindications for early postoperative physiotherapy

排除标准

  • History of previous breast cancer surgery
  • Concurrent bilateral breast cancer and/or surgery
  • History of shoulder surgery
  • Preoperative shoulder dysfunction
  • Upper extremity deep vein thrombosis
  • BMI>40 kg/m²
  • Use of an assistive walking device
  • Stage 4 metastatic cancer
  • All conditions that require close monitoring during exercise (such as uncontrolled or unstable cardiovascular disease or diabetes)
  • cognitive impairment

结局指标

主要结局

muscle shortness test

时间窗: postoperative to 3 months later

Pectoralis major and pectoralis minor muscle shortness tests.measurements will compare with operated and non-operated limb, and also subsequent.

Bioimpedance analysis for body composition determination; body fat and water percentage

时间窗: postoperative to 3 months later

Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body fat percentage, body water percentage.

Bioimpedance analysis for body composition determination; visceral fat level

时间窗: postoperative to 3 months later

Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; visceral fat level.

determination of limb volume changes

时间窗: postoperative to 3 months later

The circumference measurements for lymphedema will be calculated using the Frustum formula. calculations will compare with operated and non-operated limb, and also subsequent measurements. A volume increase of \>200 ml is interpreted as the onset of lymphedema.

Bioimpedance analysis for body composition determination; weight

时间窗: postoperative to 3 months later

Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body weight (kg), muscle mass (kg), estimated bone ratio (kg).

Bioimpedance analysis for body composition determination; energy consumption

时间窗: postoperative to 3 months later

Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; total daily energy consumption (kcal/day).

determination of shoulder and upper extremity functions

时间窗: postoperative to 3 months later

Modified Constant Murley Score for assessment of shoulder and upper extremity functions. high score indicates good function.

Bioimpedance analysis for body composition determination; metabolic age

时间窗: postoperative to 3 months later

Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; metabolic age (years).

assesment of fatigue

时间窗: postoperative to 3 months later

Cancer Fatigue Scale for assesment of fatigue. A low score indicates a low fatigue rate.

Bioimpedance analysis for body composition determination;body mass index

时间窗: postoperative to 3 months later

Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body mass index (kg/m2).

determination of subdermal fluid ratio

时间窗: postoperative to 3 months later

Moisturemeter compactD for measurement of subdermal fluid ratio. Measurements will be compared with the subsequent.

determination of cardiovascular endurance

时间窗: postoperative to 3 months later

6 Minute Walk Test (6MWT) will be used for cardiovascular endurance.Changes of \>35 m are significant changes.

次要结局

  • determination of emotional status(baseline to 3 months later)
  • Determination of quality of life(postoperative to 3 months later)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ATİYE KAŞ ÖZDEMİR

Principal Investigator; Phd. PT

Pamukkale University

研究点 (2)

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