A Personalized Physical Activity Intervention and Behavioral Change in Lung Cancer Patients: RETOS Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Sedentarism
研究概览
简要总结
Patients with lung cancer have poor physical activity and increased sedentary behavior, with the presence of high levels of fatigue.
A randomized controlled trial will be carried out to compare usual care versus a personalized exercise program in the community, in order to explore the changes on physical activity and sedentary behavior and its impact on cancer-related fatigue.
详细描述
Patients with lung cancer are characterized by having low levels of physical activity (PA) and high sedentary behavior (SB), with direct impact on their quality of life, complications and survival. Previous studies have observed that PA programs have high dropout rates and are not very sustainable over time, making it necessary to incorporate models that consider the preferences and possibilities of patients.
Objectives: To compare the effects on PA levels and SB of a 6-month personalized program vs. conventional care, in community-dwelling lung cancer survivors.
Methods: Controlled and randomized pilot study, with intervention and control group, pilot study. 40 non-small cell lung cancer survivors (18 to 70 years old) will be included. The control group will receive the usual recommendations regarding an active and healthy lifestyle. The intervention group will follow a personalized PA and behavior change program in the community, supervised by a physiotherapist expert in therapeutic exercise.
PA and SB measurements will be carried out using accelerometry and self-reported questionnaires. As secondary variables, functional capacity, lung function, dyspnea and fatigue, as well as quality of life will be measured. A motivational interview will be conducted to personalize the intervention considering clinical characteristics, treatment, motivation and preferences. The intervention will be re-evaluated and adapted monthly, considering the results reported weekly.
Through covariance analysis, the levels of PA and SB, among other factors, measured at the beginning and at the end of the intervention will be evaluated.
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 (Investigator)
盲法说明
The investigator and the professional who will do the statistical analyses, will be blinded to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a diagnosis of non-small cell lung cancer who are candidates for radical and/or metastatic treatment
- •ages between 18 and 70
- •ability to answer questionnaires in Spanish
- •who have accepted participation and signed the informed consent
排除标准
- •participants with a life expectancy of less than 6 months
- •patients with levels of physical activity greater than 240 metabolic equivalents (MET) METs/day
- •patients who have a contraindication to exercise
- •patients with dementia or spatial disorientation or behavioral disorders
结局指标
主要结局
Sedentarism
时间窗: Before and after intervention (6 months)
Weekly sedentary behavior measured with the Sedentary Behaviour Questionnaire (SBQ). The SBQ measures the time in minutes spent in 9 different sedentary activities during a week, differentiating working days and week-ends. The score is the separately sum of the hours per day for week days and week-end days. A higher score is indicative of longer time spent in sitting and therefore an indication of higher sedentarism.
Physical Activity
时间窗: 7 consecutive days, before and after intervention (6 months)
Level of daily physical activity measured with accelerometry. Accelerometry will be worn by patients for 7 consecutive days and will measure the time in minutes spent in low (1.6 - \<3 METs), moderate (3.0 - \<6.0 METs) and vigorous (⩾6 METs) physical activities.
次要结局
- Walking distance(Before and after intervention (6 months))
- 1-minute Sit-to-Stand test(Before and after intervention (6 months))
- Dyspnea(Before and after intervention (6 months), and once a week during intervention.)
- Cancer Quality of Life Questionnaire(Before and after intervention (6 months).)
- Calf circumference(Before and after intervention (6 months).)
- Sleep quality(Before and after intervention (6 months), and once a week during intervention period (6 months).)
- Pulmonary function(Before and after intervention (6 months))
- Fatigue(Before and after intervention (6 months), and once a week during intervention.)
- IPAQ short form(Before and after intervention (6 months).)
- Hand grip test(Before and after intervention (6 months).)
- Adherence(Once a week during intervention period (6 months).)
- Bioimpedance(Before and after intervention (6 months).)