Comparing a Technology-enabled, Remotely Delivered Exercise Intervention to Partly-supervised Structured Exercise in Breast Cancer Survivors: a Randomised and Controlled Non- Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in VO2max (maximum oxygen uptake)
研究概览
简要总结
Supervised, prescribed exercise has positive effects on body composition, physical functioning, psychological wellbeing and quality of life for patients after breast cancer treatment. However, exercise interventions are often time consuming, commonly take place at a health or fitness facility, and usually require a trained professional to be present. Cost-effective, enjoyable and practical approaches, that can be adopted at home or in local surroundings are needed. For example, an alternative approach is using an electronic physical activity tracking wristwatch to help patients engage with exercise or physical activity. Research demonstrates the importance of structured and supervised exercise for breast cancer survivors. However, it is not known whether other approaches (e.g. home-based exercise and physical activity) alongside the use of personalised technology-enabled feedback, can cause similar improvements to health when compared to structured exercise. The overall aim of this study is to determine whether cardiorespiratory fitness is changed by a technology enabled, remotely delivered exercise intervention and to determine whether this change is similar to the change caused by a partly supervised, prescribed exercise intervention. This study will also determine the influence of both interventions on physical functioning, body composition and blood pressure.
详细描述
Intervention groups:
Remotely-supported exercise group:
The remotely-supported group will received a target for a total duration of exercise each week (outdoor walking) progressing in duration from 105 to 150-min and 55% to 70% of V̇O2max. By week 7, the exercise prescription will align with common physical activity recommendations. Participants will be advised how they can break down their target into manageable bouts (e.g., 3 × 35 min walks = 105-min in week 1) and will be instructed to accumulate exercise with a minimum bout-length of 10-min. Intensity will be checked by participants using heart-rate thresholds that corresponded to their V̇O2max. Participants will take part in a weekly 30-min telephone calls to discuss the exercise they have completed, as documented by an internet-based data visualisation platform with data input from a wrist worn fitness tracker that records accelerometry data and heart rate
Partly-supervised exercise group:
The partly-supervised exercise group will undertake 2 supervised (laboratory-based treadmill and cycle ergometer exercise) and 1 unsupervised session per week (e.g., outdoor walking) progressing from 35 to 50-min and 55% to 70% of V̇O2max. By week 7, the exercise prescription will align with common physical activity recommendations. During supervised laboratory sessions, intensity will be confirmed and adjusted using indirect calorimetry. The intensity of unsupervised exercise sessions will be recorded using a chest-worn heart rate monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 35-69 years
- •History of previous stage I-III invasive breast cancer
- •No history of metastatic cancer
- •No significant cardiac co-morbidity
- •No diagnosis of bilateral breast cancer
- •> 2 months from surgery, chemotherapy and radiotherapy treatments, however patients continuing with endocrine therapy will be included.
- •BMI 20 > <35 kg.m2
- •Oncologist clearance
- •Pass physical activity readiness questionnaire (PAR-Q)
- •Last menstrual period >1 year ago
排除标准
- •Current malignancy
- •Previous superficial basal cell carcinoma of the skin or prior carcinoma-in situ (including ductal carcinoma in situ/lobular carcinoma in situ of breast) is allowed
- •Cardiovascular Disease
- •Severe hypertension (>200/120 mmHg)
- •5+ years since last treatment
- •Active infection at recruitment
- •Undertaking regular, structured, exercise training defined as self-reported structured physical activity lasting > 30 minutes on two or more occasions per week (measured before the first visit using the international physical activity questionnaire (IPAQ))
- •Contraindication to undertaking an exercise programme including previously diagnosed significant osteoporosis or other co-morbidities at the oncologist's discretion
结局指标
主要结局
Change in VO2max (maximum oxygen uptake)
时间窗: 9 weeks
Measure of cardiorespiratory fitness
次要结局
- Change in Body composition(9 weeks)
研究者
James Turner, Ph.D., FHEA
Dr James Turner
University of Bath