Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer (The BE-BALANCED Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Accrual
研究概览
简要总结
This study will explore the feasibility (suitability), efficacy (research-setting outcomes), and participant satisfaction of a virtually-supervised 12-week exercise and diet intervention for women with ovarian cancer. It will include exercise, behavior change strategies, and guidance around healthy eating. Participants will be instructed and supervised virtually in two exercise sessions weekly for 12 weeks by a professional trained to deliver the program. An additional 1 exercise session per week, completed independently, will be added from weeks 4-12 of the program. Finally participants will participate in two separate virtual group nutrition sessions. Assessments will occur at baseline, end-of-intervention, and 6 months post-baseline.
详细描述
Purpose: To assess the feasibility, preliminary efficacy, and patient perspectives of a 12-week supervised, virtually-delivered exercise and healthy eating program for women living with and beyond ovarian cancer.
Hypothesis: The investigators hypothesize that the program will be feasible and will demonstrate efficacy, and that patient perspectives will be overall positive and in support of the program.
Justification: Women living with and beyond ovarian cancer exercise at levels below the general population, and are at an increased risk for falls. Exercise and healthy eating programming is not a part of routine care. This project has the potential to demonstrate a feasible and relatively low-cost option for offering such programming.
Objectives: the objectives of this program are: 1) Primary Objective: To measure the feasibility of delivering the BE-BALANCED program from a virtual (i.e. live video) setting. Feasibility will be evaluated per individual item based on a priori targets; 2) Secondary Objective: To evaluate the preliminary efficacy of the BE-BALANCED program; 3) Tertiary Objective: To evaluate patient satisfaction (post-intervention only)
Research Design: This study is a prospective single-arm feasibility study.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •50-75 years of age (women tend to be older at time of diagnosis, with a median age in Canada of 62 years);
- •Completed primary chemotherapy treatment (oral maintenance therapy allowed);
- •Are within one year of completion of primary chemotherapy without known recurrence;
- •Have access to a smartphone, tablet, laptop, or desktop computer with a camera and microphone, and a reliable internet connection;
- •Speak English, to ensure safety in delivery of the physical activity intervention
排除标准
- •Do not pass pre-exercise screening for safety and do not subsequently provide written medical clearance from their physician to participate;
- •Do not consent to adhere to safety requirements to participate in a virtual delivery program (i.e., be seen on video for duration of class);
- •Experienced a fall requiring medical attention in the prior 6 months as individuals may be a higher risk for fall in a virtual physical activity program setting and would be more appropriate for referral to falls clinic
结局指标
主要结局
Accrual
时间窗: Baseline (0 weeks)
Assessed by meeting accrual targets (number recruited)
Intervention Adherence
时间窗: Baseline to 12 weeks
Assessed as number of supervised virtual sessions that a participant attended, out of a total of 24 group exercise sessions, and number of self-directed sessions completed, out of a total of 9 sessions.
Fidelity of group belonging
时间窗: Baseline to 12 weeks
Group Belonging Scale (0-20; higher is better)
Attrition
时间窗: Baseline to 12 weeks
Assessed as number of drop-outs during the 12-week program.
次要结局
- Physical function: Gait speed(Change from baseline to 12 weeks (end of intervention))
- Physical function: Functional mobility(Change from baseline to 12 weeks (end of intervention))
- Physical function: Lower extremity strength and endurance(Change from baseline to 12 weeks (end of intervention))
- Physical function: Upper extremity strength and endurance(Change from baseline to 12 weeks (end of intervention))
- Physical function: Balance(Change from baseline to 12 weeks (end of intervention))
- Cardiovascular Fitness(Change from baseline to 12 weeks (end of intervention))
- Height(Change from baseline to 12 weeks (end of intervention))
- Weight(Change from baseline to 12 weeks (end of intervention))
- Waist circumference(Change from baseline to 12 weeks (end of intervention))
- Body mass index(Change from baseline to 12 weeks (end of intervention))
- Hip circumference(Change from baseline to 12 weeks (end of intervention))
- Usual physical activity levels(Change from baseline to 12 weeks (end of intervention))
- Health-related quality of life: Physical Health(Change from baseline to 12 weeks (end of intervention))
- Health-related quality of life: Mental Health(Change from baseline to 12 weeks (end of intervention))
- Depression and anxiety(Change from baseline to 12 weeks (end of intervention))
- Falls(Change from baseline to 12 weeks (end of intervention))
研究者
Kristin Campbell
Professor
University of British Columbia