Randomized Controlled Trial of Progressive Resistance Exercise Training for Spinal Accessory Neurapraxia/ Neurectomy in Head and Neck Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months)
研究概览
简要总结
The purpose of this study is to investigate the effect of a progressive therapeutic exercise program on specific physical and functional deficits in the neck and shoulder region occurring as a result of head and neck cancer treatment.
详细描述
We will be conducting a randomized controlled trial to evaluate the effects of progressive resistance exercise training (PRET) on shoulder and neck dysfunction due to spinal accessory neurapraxia/ neurectomy in patients with head and neck cancer. Sixty-four head and neck cancer survivors will be randomly assigned to PRET or standard care. Participants assigned to the PRET group will exercise 3 times per week for 12 weeks. The goal of the exercise program will be to enhance scapular stability, and improve mobility and strength of the upper extremity. The resistance exercise program will be progressive in terms of the number of sets and repetitions performed, as well as amount lifted, depending on baseline strength levels and overall performance status. The primary outcomes for the study include pain and dysfunction, active and passive range of motion measures, strength and endurance testing, and quality of life. Nerve conduction testing and electromyography will be performed to assess/ monitor the status of the spinal accessory nerve and trapezius muscle function respectively.
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 (Outcomes Assessor)
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
- •Squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx OR squamous cell carcinoma metastatic to the neck from unknown primary site; probable occult mucosal origin in the head and neck
- •Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection
- •Karnofsky Performance Status greater than or equal to 60%
- •No evidence of residual cancer in the neck and no distant (M0) metastasis
- •Participants must have completed their head and neck cancer treatment
排除标准
- •A history of shoulder or neck pathology unrelated to cancer treatment
- •Serious co-morbid medical illness or psychiatric illness
结局指标
主要结局
Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months)
时间窗: baseline, 12 weeks, 6 months, 12 months
Active and passive range of motion (baseline, 12 weeks)
时间窗: baseline, 12 weeks
Muscular strength and endurance (baseline, 12 weeks)
时间窗: baseline, 12 weeks
Quality of life (baseline, 12 weeks, 6 months, 12 months)
时间窗: baseline, 12 weeks, 6 months, 12 months
次要结局
- Nerve conduction testing (baseline, 12 weeks as indicated)(Baseline)
- Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months)(baseline, 12 weeks, 6 months, 12 months)
- Electromyography (baseline, 12 weeks as indicated)(Baseline)