Evaluating the Acceptability of a Cycling-Based Aerobic Exercise Intervention for Individuals With Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Proof-of-Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
CYCLE-CIPN is a proof-of-concept study designed to evaluate whether a prescribed aerobic exercise intervention has the potential to reduce the symptoms and functional impact of CIPN. The small number of participants in the proposed study will allow us to make decisions on the feasibility ("go/no-go") of a future larger-scale trial.
The protocol will assess feasibility and acceptability through recruitment, completion, adherence, program satisfaction, and safety. The study will also evaluate CIPN symptoms using both patient-reported and objective outcome measures, as well as fitness and quality of life outcomes. We aim to recruit 30 participants.
The Health Research Board of Alberta Cancer Committee has approved this study. Participants will participate in a stationary cycling-based aerobic exercise program biweekly for 12 weeks. Exercise sessions will be supervised and progressive, between 30 and 60 minutes each.
详细描述
CIPN is a common and dose-limiting side effect of neurotoxic chemotherapeutic agents used in cancer treatments, with symptoms affecting up to 100% of patients depending on the drug class. These symptoms-classified as positive (e.g., tingling, pain, allodynia) or negative (e.g., numbness, decrease in fine motor skills) -primarily occur in the hands and feet. CIPN persists in approximately 30% of patients six months post-treatment, significantly impacting quality of life. As there are no pharmacological treatments established for CIPN, there is a critical need to explore lifestyle interventions to improve survivorship care.
Exercise is a promising lifestyle intervention for managing CIPN, with research suggesting improvements in CIPN symptoms such as pain and numbness. Most existing studies have utilized multimodal exercise interventions (typically aerobic, resistance, and balance training) and often rely exclusively on patient-reported outcome measures (PROMs), limiting generalizability. There is significant variability in CIPN outcome measures used across studies, as a standardized core outcome set has not yet been established. Aerobic exercise may reduce CIPN symptoms through neurotrophins that affect neurons, peripheral nerves, and inflammation; however, the exact mechanisms remain unclear. While aerobic exercise shows considerable potential for CIPN symptom reduction, its isolated effects on CIPN-associated symptoms and function observed through the use of both PROMs and objective clinical measures remain unexplored. The FITT principle (Frequency, Intensity, Time, Type) provides a standardized framework for exercise prescription, yet few studies have examined its application in dosing CIPN-specific aerobic exercise interventions. Stationary cycling offers a safe, non-weight-bearing aerobic exercise mode that is accessible for individuals with CIPN. To address current research gaps, further investigation is warranted to examine the feasibility, acceptability, and outcomes of cycling-based aerobic exercise intervention using both patient-reported and objective outcome measures.
The primary objective of this study is to determine the feasibility and acceptability of a stationary cycling-based aerobic exercise program for individuals with CIPN using both objective and patient-reported outcome measures, as defined by:
Recruitment rate: 30 participants recruited within one year
Completion rate: >70% of participants consenting to the study complete the 12-week assessment
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
盲法说明
An independent assessor will be used to collect post-intervention outcomes.
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
- •18 years or older
- •Cancer diagnosis stage I to III
- •CIPN: grade 1 (mild)
- •Receiving or have received chemotherapy treatment for cancer
- •Speak, read and understand English
排除标准
- •Medical conditions that cause additional neuropathy symptoms (i.e. diabetes)
- •Any uncontrolled medical conditions
- •Will undergo surgery or radiation therapy during the study period
- •Are already receiving an aerobic exercise training program
- •Are already participating in an exercise-based research study
- •Are unable to provide signed informed consent
研究组 & 干预措施
Aerobic exercise intervention
Cycling-based aerobic exercise
干预措施: Exercise (Behavioral)
结局指标
主要结局
Recruitment
时间窗: One year
Recruitment rate of 30 participants in one year
次要结局
- Study completion(One year)
- Program satisfaction(12 weeks)
- Adherence(12 weeks)