Multiple Myeloma Exercise Prehabilitation for Individuals Awaiting a Stem Cell Transplantation (MOTIVATE): A Randomized Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Study completion rate
研究概览
简要总结
The primary purpose of this study is to see if individuals with Multiple Myeloma are able and interested in taking part in a tailored exercise program while undergoing their chemotherapy prior to a stem cell transplant. We also hope to learn if this type of program, along with a flexible delivery format (in-person and virtual), helps in maintaining or improving physical fitness, muscle mass and strength, and quality of life during chemotherapy.
详细描述
MOTIVATE is a multi-methods feasibility randomized trial. We will recruit a minimum of 30 individuals with multiple myeloma who are undergoing chemotherapy prior to a Stem Cell Transplant. The study will be conducted in two phases:
Phase I: Feasibility Study The aim of this phase is to determine the feasibility and preliminary effectiveness of a 10-week exercise intervention compared to physical activity counseling alone.
Phase II: Qualitative Study The aim of this phase is to evaluate the acceptability of the Healthy Eating Active Living (HEAL-ME) app design, program delivery/design, and perceived effectiveness of the intervention at the level of the participant.
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
- Single (Outcomes Assessor)
盲法说明
An independent assessor will conduct the post-intervention assessment. The independent assessor will be blinded to group assignment.
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
- •Have a diagnosis of Multiple Myeloma
- •Be transplant eligible
- •Be undergoing chemotherapy prior to, or following an autologous stem cell transplant as part of their cancer treatment; or transplant ineligible.
- •Be an Alberta resident
- •Be ≥18 years of age
- •Be able to read and understand English.
排除标准
- •Their disease status/comorbidities preclude exercise testing or participation
- •They are unable to commit to the 10-week exercise program and/or testing sessions at the Cancer Rehabilitation Clinic at the University of Alberta
- •They do not have regular access to the internet and/or an electronic device in the home.
研究组 & 干预措施
Standard Care
Participants in this group will receive exercise counseling as per standard care for 10-weeks. This will include: (1) counseling on remaining active during chemotherapy; (2) handouts on the benefits of exercise during chemotherapy, exercise behavior change strategies, and how to exercise safely. Participants will be encouraged to remain as physical active as possible. As per American College of Sports Medicine 2019 guidelines, participants will be advised to take part in moderate intensity exercise for a total of 90 minutes per week.
干预措施: Standard Care (Behavioral)
Supported Exercise Group
Participants assigned to the exercise group will take part in a 10-week exercise program delivered in-person and through the HEAL-ME app. The program comprises (1) a minimum of one supervised session (in-person or virtual through a Zoom platform embedded in HEAL-ME), (2) a minimum of one independent exercise workout within the HEAL-ME app, and (3) exercise specific education content as per standard care.
干预措施: Supported Exercise (Behavioral)
结局指标
主要结局
Study completion rate
时间窗: 10-weeks
The percentage of participants who complete the study, including the intervention and follow-up assessment
次要结局
- Functional Assessment of Cancer Therapy Multiple Myeloma(10 weeks)
- Thigh muscle thickness(10 weeks)
- Body height(10 weeks)
- Six-minute walk test(10 weeks)
- Attendance rate(18 months)
- Edmonton Symptom Assessment System(10 weeks)
- Grip Strength(10 weeks)
- Shoulder flexion range of motion(10 weeks)
- Sit and reach test(10 weeks)
- Functional Assessment of Cancer Therapy: Fatigue Subscale (13-item)(10 weeks)
- Body weight(10 weeks)
- Calf muscle size(10 weeks)
- Recruitment rate(18 months)
- Short Physical Performance Battery(10 weeks)
- One leg stance balance(10 weeks)