EX-MED Cancer Sweden: A Randomised Controlled Trial of Distance-based Exercise for People Treated for Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Health-related quality of life
研究概览
简要总结
Regular exercise has been shown to have beneficial health effects in cancer survivors, including improving quality of life and other important health outcomes. However, providing people with cancer with easily accessible, high-quality exercise support and programs is a challenge. Therefore, there is a need to develop easily accessible exercise programs that draw upon the current evidence. Supervised, distance-based exercise programs have the benefit of reaching out to many people while providing the support of an exercise professional.
The aim of the EX-MED Cancer Sweden trial is to examine the effectiveness of a supervised, distance-based exercise program, in people previously treated for breast, prostate, or colorectal cancer, on health-related quality of life (HRQoL), as well as other physiological and patient-reported health outcomes. Participants will be randomized to a 3-month supervised, distance-based exercise program or to a usual care control group.
Testing timepoints are baseline, 3 months (end of intervention) and 6 months (3 month followup). At these timepoints, patients will be asked to fill in online questionaires, and and undergo physical tests. A selection of the particpants and personal trainers involved in the intervention will also be invited to participate in focus group discussion or interviews about the experiences of being involved in the EX-MED Cancer Sweden program.
详细描述
The primary aim of the study is to examine the effectiveness of EX-MED Cancer Sweden on health-related quality of life in people diagnosed with breast, prostate, and colorectal cancer.
The secondary aims are to examine the effect of the program on other important endpoints such as physical activity level, physical function, muscle strength, exercise capacity, symptoms, and body composition (lean and fat mass).
To determine the sustainability of the effects of the supervised program, the study includes a 3-month follow-up time point (6 months post-baseline)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •18 years or older
- •males or females
- •people diagnosed with any type of stage I-IIIa breast, prostate or colorectal cancer who have undergone and completed curative treatment (note: participants are eligible if they are currently receiving/scheduled to receive anti-hormonal therapy) at the Karolinska Comprehensive Cancer Centre, Sweden
排除标准
- •currently receiving or scheduled to receive cancer treatment (except anti-hormonal therapy)
- •any medical conditions that may prevent safe participation in the testing or exercise demands of the study
- •performing regular exercise throughout the last month defined as undertaking at least 150 mins moderate intensity aerobic exercise and two or more structured resistance exercise sessions per week
- •unable to read and speak Swedish.
研究组 & 干预措施
Exercise
The intervention group will, in addition to routine clinical care according to (inter-) national guidelines, receive an exercise program of resistance and aerobic exercise delivered live online by an upskilled exercise professional in group exercise classes twice weekly for 3 months
干预措施: Exercise (Behavioral)
Control
The control group will receive routine clinical care according to (inter-) national guidelines
结局指标
主要结局
Health-related quality of life
时间窗: 3 months
Assessed by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) (global quality of life summary scale). Patients responds to questions about their quality of life on a scale of 1- (not at all) to 4 (alot).
Health-related quality of life
时间窗: Baseline, 3 months
Assessed by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) (global quality of life summary scale). Patients responds to questions about their quality of life on a scale of 1- (not at all) to 4 (alot).
次要结局
- Health-related quality of life(6 months)
- Quality adjusted life years(6 months)
- Upper body muscle strength(6 months)
- Symptoms and symptom burden (total symptoms scale)(6 months)
- Self reported physical activity(6 months)
- Cardiorespiratory fitness(6 months)
- Lower body muscle strength(6 months)
- Whole body muscle mass(3 months)
- Whole body fat mass(6 months)
- Self efficacy of exercise(6 months)
- Cancer related fatigue(6 months)
- Physical function of the lower body(6 months)
- Whole body fat percentage(6 months)
- Physical function of the lower body(Baseline)
- Cancer related fatigue(Baseline)
- Cancer related fatigue(3 months)
- Symptoms and symptom burden (total symptoms scale)(Baseline)
- Symptoms and symptom burden (total symptoms scale)(3 months)
- Cardiorespiratory fitness(Baseline)
- Cardiorespiratory fitness(3 months)
- Physical function of the lower body(3 months)
- Upper body muscle strength(Baseline)
- Upper body muscle strength(3 months)
- Lower body muscle strength(Baseline)
- Lower body muscle strength(3 months)
- Whole body muscle mass(Baseline)
- Whole body fat percentage(Baseline)
- Whole body fat percentage(3 months)
- Self reported physical activity(Baseline)
- Self reported physical activity(3 months)
- Self efficacy of exercise(Baseline)
- Self efficacy of exercise(3 months)
- Quality adjusted life years(Baseline)
- Quality adjusted life years(3 months)
研究者
Yvonne Wengstrom
Professor
Karolinska Institutet