Effect of an Integrated Exercise Program Concomitant With Radiotherapy on Functional Capacity in Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Adherence to the exercise program
研究概览
简要总结
Study objective and procedures
The objective of CURIE-LC is to evaluate the feasibility (i.e., whether it is possible and safe) of carrying out a comprehensive exercise program during combined radiotherapy and chemotherapy in patients with lung cancer. The study will assess whether patients can adhere to the exercise program while receiving oncologic treatment and will explore its effects on physical fitness and quality of life.
What does participation involve?
If participants choose to take part, they will join a supervised exercise program conducted throughout the chemoradiotherapy treatment. The program includes three main components, tailored to the individuals' abilities:
Inspiratory breathing exercise: training with a specialized device to strengthen the breathing muscles and improve lung capacity.
Aerobic exercise: moderate-intensity aerobic activity (e.g., treadmill walking or stationary cycling) several days per week to improve endurance and cardiovascular health.
Strength training: muscle-strengthening exercises (e.g., light weights or resistance bands) twice per week to maintain or increase arm and leg strength.
A physiotherapist or other trained professional will guide the participant at all times to ensure exercises are performed safely and appropriately. Sessions will last approximately 20 to 60 minutes and will be coordinated with the radiotherapy/chemotherapy schedule so as not to interfere with the treatment.
In addition to the exercise sessions, participants will undergo physical assessments and complete questionnaires at several time points. Before starting and at the end of the program, the investigagtors will measure functional capacity using the 6-minute walk test (6MWT) and assess respiratory muscle strength using maximal inspiratory and expiratory pressures (PImax and PEmax). Handgrip strength will also be measured. Participants will complete questionnaires about health status, fatigue, mood, and quality of life. These evaluations will help determine the impact of exercise during treatment.
The exercise program will last for the duration of the treatment, approximately 7 to 9 weeks, with a short-term follow-up after treatment ends. Overall, participation involves attending the scheduled weekly exercise sessions during treatment, plus several evaluation visits (before, during, at the end of the program, and a few months later). Exact timing and frequency will be explained and planned according to the individual situation, aiming to minimize disruption to daily routine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Histological diagnosis of non-small cell lung cancer (NSCLC) at stage II-III (locally advanced), unresectable/inoperable.
- •Candidate for radical radiotherapy with concomitant chemotherapy, with or without maintenance Durvalumab.
- •ECOG performance status ≤2 (or Karnofsky index ≥60).
- •Ability to communicate adequately with the research team and to complete questionnaires and functional tests.
- •Signed written informed consent after receiving detailed information about the study.
排除标准
- •Decompensated cardiorespiratory comorbidities that contraindicate moderate-intensity physical exercise:
- •New York Heart Association (NYHA) class III-IV congestive heart failure or unstable angina.
- •Recent myocardial infarction (<6 months) or uncontrolled arrhythmias.
- •Very severe chronic obstructive pulmonary disease (COPD) GOLD IV with recent exacerbations, permanent home oxygen therapy, or severe pulmonary hypertension.
- •Severe physical or neurological limitations that prevent exercise.
- •Absolute medical contraindications to inspiratory muscle training: unresolved pneumothorax, recent thoracic surgery (<4 weeks), or active hemoptysis.
- •Refusal or inability to understand/follow the program instructions (e.g., severe cognitive impairment, insurmountable language barrier).
研究组 & 干预措施
Multimodal exercise program during chemoradiotherapy
Patients will start 2 weeks prior to radiotherapy treatment. The intervention will consist of 3 days of aerobic exercise, 2 days of resistance training and 5 days of unsupervised inspiratory muscle training during 9 weeks.
干预措施: Multimodal exercise (Other)
结局指标
主要结局
Adherence to the exercise program
时间窗: From enrollment to the end of treatment at 7-9 weeks
Adherence will be primarily measured as compliance with the prescribed exercise dose, not only attendance. Each participant will complete a structured diary (daily log) that will record: * IMT: minutes and sets completed. * Aerobic exercise: minutes, modality, and perceived intensity using the modified Borg scale. * Strength exercise: exercises/sets/repetitions completed and load (or perceived effort). During supervised sessions, the physiotherapist will confirm compliance; during unsupervised sessions, the diary will be reviewed weekly. Adherence will be calculated using the average of components weighted by the prescribed dose, and the program will be considered feasible if: 1. the overall mean adherence is ≥70% of the prescribed dose; and 2. ≥70% of participants achieve ≥70% adherence.
Patient Reported Experience Measures
时间窗: At the end of intervention at 9 weeks
Evaluates the patient's satisfaction with and acceptance of the program. Measurement instrument: An ad hoc-designed satisfaction survey, with standardized items on a Likert scale (e.g., overall satisfaction, perceived usefulness, session comfort, likelihood of recommending the experience, etc.). Procedure: The satisfaction survey will be administered at the end of the intervention. Patients' responses regarding different organizational and perceived aspects of the program will be collected; these responses will be transformed into quantitative scores (0-10 or 1-5 depending on the Likert scale used) and/or into the proportion of positive responses. This PREM will provide information on the acceptability of the intervention.
Adverse events
时间窗: From start of intervention through 3 months after completion of the intervention (approximately 5 months)
Refers to the incidence of clinical adverse effects related to oncological treatment or to the performance of exercise. Measurement instrument: Standardized toxicity recording according to CTCAE v5.0 criteria (Common Terminology Criteria for Adverse Events, version 5.0). Procedure: Throughout the study, adverse events will be systematically monitored and documented, distinguishing those associated with radio/chemotherapy treatment from those potentially attributable to exercise. In particular, the following will be monitored: acute pneumonitis ≥ grade 2, radiation-induced esophagitis, weight loss ≥5% from baseline, unplanned hospitalizations, and hematological toxicities (e.g., neutropenia, anemia, or thrombocytopenia ≥ grade 2). Each event will be evaluated by the radiation oncologist using the CTCAE v5.0 scale to assign a severity grade. The exercise program will be considered safe if no serious exercise-related adverse events are observed.
次要结局
未报告次要终点