Investigation of the Effects of Home-Based Exercise Program Applied During Radiotherapy on Posture, Range of Motion, Muscle Strength, Fibrosis, Lymphedema and Swallowing Functions in Patients Diagnosed With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Range of Motion
研究概览
简要总结
The purpose of this study is to examine the effects of exercise on individuals with head and neck cancer who are receiving postoperative radiotherapy.
The study is based on three primary hypotheses:
- Exercise may help reduce or prevent the loss of normal range of motion that can occur during radiotherapy.
- Exercise may help maintain muscle strength or lead to improvements in muscle strength.
- Exercise may help maintain or improve postural alignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Outcomes Assessor)
盲法说明
This was an open-label study. Outcome assessments and interventions were performed by the same researcher. Statistical analysis was conducted by an independent biostatistician.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of squamous cell carcinoma of the head and neck.
- •Undergoing unilateral neck dissection surgery.
- •Scheduled to receive curative radiotherapy.
- •Age 18 years or older.
- •Willingness to participate and ability to comprehend exercise instructions.
排除标准
- •Presence of distant metastasis.
- •Presence of a tracheostomy.
- •History of previous trauma or surgery involving the shoulder or cervical region.
- •Neurological disorders affecting upper quadrant function. Recurrence of disease during the study period.
研究组 & 干预措施
Structured Home-Based Physiotherapy Program
Participants in the intervention group will receive instruction in a structured home-based exercise program to be implemented throughout the radiotherapy period. Adherence, technique, and progression will be monitored and reinforced through weekly in-person sessions with a qualified professional.
干预措施: Home-based exercise (Procedure)
Usual Care / Standard Follow-Up
Participants in the control group will receive only radiotherapy and will not undergo any physiotherapy interventions during this period. At the end of the radiotherapy, both groups will be re-evaluated, and participants in the control group will then be provided with appropriate treatment and home-based exercise programs.
结局指标
主要结局
Range of Motion
时间窗: Baseline and Day 25 (end of radiotherapy)
Range of motion of the cervical region will be assessed using a cervical range of motion (CROM) device, and shoulder range of motion will be assessed using a goniometer, including flexion, extension, lateral flexion, rotation, abduction, and external rotation.
次要结局
- Muscle Strength(Baseline and Day 25 (end of radiotherapy))
- Postural Alignment(Baseline and Day 25 (end of radiotherapy))
- Fibrosis Severity(Day 25 (end of radiotherapy))
- Lymphedema(Day 25 (end of radiotherapy))
- Swallowing Function(Baseline and Day 25 (end of radiotherapy))
研究者
Burak Ertürk
Research Assistant
Karadeniz Technical University