Feasibility and Safety of Heavy Lifting Strength Training in Head and Neck Cancer Survivors Post-Surgical Neck Dissection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Recruitment Rate
研究概览
简要总结
The LIFTING trial will examine the feasibility and safety of a heavy lifting strength training (HLST) program in head and neck cancer survivors (HNCS) at least 1 years post surgical neck dissection. The trial will determine whether this training style is safe and feasible in HNCS. Physical and psychosocial changes will also be reported.
详细描述
RATIONALE Despite improvements in treatments, HNCS still endure numerous acute and chronic side effects. Strength training has been shown to manage some of these side effects but most interventions have involved light-to-moderate resistance training programs. HLST may produce better outcomes but it is unknown if such a weight training program is feasible and safe for HNCS.
OBJECTIVE The primary aim of this proposed study is to examine the feasibility and safety of a HLST program in HNCS at least 1 year post-surgical neck dissection.
METHODS This single arm feasibility study will recruit 15-20 HNCS to complete the HLST program 2 times per week. The primary feasibility outcomes will include the eligibility rate (with reasons for ineligibility), recruitment rate (with reasons for refusal), 1 repetition maximum testing rate (with reasons for not completing the test), program adherence (including attendance, dose modifications, and progression), and follow-up assessment rate (with reasons for drop out). The primary efficacy outcome will be strength gains from baseline. Secondary efficacy outcomes will include physical functioning, quality of life, fear of cancer recurrence, pain, body composition, anxiety, fatigue, stress, shoulder mobility, self-esteem, sleep, and motivation to engage in a HLST program.
SIGNIFICANCE Weight training is an effective intervention in HNCS but the optimal weight training prescription is unknown. If heavy weight training is deemed safe and feasible in HNCS, it can be compared to light-to-moderate load weight training to determine if it is a better prescription for improving outcomes that are important to HNCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •previously diagnosed with any subtype and stage of head and neck cancer
- •at least one year post surgical neck dissection for head and neck cancer and showing full shoulder range of motion or recovery of the spinal accessory nerve
- •adults ages 18 and older
- •no unmanaged medical conditions, alcohol, and drug abuse
- •approved for a heavy lifting strength training program by the treating surgeon and a certified exercise physiologist
- •ability to understand and communicate in English
排除标准
- •having comorbidities or uncontrolled medical conditions that their referred clinicians indicate as inappropriate to participate in exercise
结局指标
主要结局
Recruitment Rate
时间窗: Over 12 weeks
Recruitment rate (with reasons for refusal). Recruitment minimum: 15 participants Recruitment maximum: 20 participants Higher number= better and more data
Program Adherence
时间窗: Over 12 weeks
Program adherence minimum: 80% Program adherence maximum: 100% Higher score= better adherence
Muscular Strength
时间窗: Changes from baseline to 12 weeks
Change in muscular strength from baseline to postintervention with be assessed using maximal strength tests. Minimum: none Maximum: none Higher score= better strength
次要结局
- Self-Esteem(Changes from baseline to 12 weeks)
- Weight(Changes from baseline to 12 weeks)
- Fear of cancer recurrence(Changes from baseline to 12 weeks)
- Stress(Changes from baseline to 12 weeks)
- Motivation(Changes from baseline to 12 weeks)
- Cancer Symptom Burden(Changes from baseline to 12 weeks)
- Post Traumatic Growth after cancer(Changes from baseline to 12 weeks)
- Height(Changes from baseline to 12 weeks)
- Physical functioning(Changes from baseline to 12 weeks)
- Waist to hip ratio (body composition)(Changes from baseline to 12 weeks)
- Anxiety(Changes from baseline to 12 weeks)
- Fatigue(Changes from baseline to 12 weeks)
- Shoulder Mobility(Changes from baseline to 12 weeks)
- Sleep(Changes from baseline to 12 weeks)
- Cancer specific quality of life(Changes from baseline to 12 weeks)