Feasibility and Safety Profile of a 3-month Aerobic and Resistance Exercise Intervention for Individuals Diagnosed With Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Adherence Assessment
研究概览
简要总结
Our proposed study will focus on addressing the feasibility, safety and benefits of a 3-month exercise intervention among individuals diagnosed with melanoma.
The study will be conducted at University of Miami Miller School of Medicine. Eligible participants (n=24) will be randomized into 3 months of wellness education (n=12) or structured exercise (n=12).
详细描述
Our proposed study will focus on addressing the feasibility, safety and benefits of a 3-month exercise intervention among individuals diagnosed with melanoma.
The study will be conducted at University of Miami Miller School of Medicine. The eligible participants will meet the following inclusion and exclusion criteria.
Inclusion criteria: (a) men and women (≥ 18 years of age) with melanoma cancer within one year from diagnosis, (b) not meeting the guidelines for physical activity (less than 150 minutes of moderate intensity activity or 75 minutes of vigorous intensity activity a week for 6 weeks prior the enrollment) (c) a commitment to two weekly supervised exercise sessions or bi-monthly educational sessions for three months at University of Miami Miller School of Medicine and (d) able to understand, read and write English.
Exclusion criteria: (a) participants for whom physical activity is contraindicated because of comorbid conditions, (b) participants with dementia, altered mental status or psychiatric condition and (c) participants who are unwilling or unable to provide informed consent.
The participants (n=24) will be randomized into 3 months of: 1) wellness education (n=12) or 2) structured exercise (n=12). All participants will receive standard treatment as directed by their oncologists. Individuals in the wellness education group will attend bi-monthly sessions where they will receive general wellness information pertaining to physical activity, nutrition, sleep, weight management and mindfulness. Individuals in the structured exercise group will attend supervised exercise sessions twice per week and receive a tailored daily walking plan using physical activity trackers. A comprehensive assessment will be conducted at baseline and 3-months, which will include demographics, medical and treatment history, anthropometrics, quality of life, physical fitness, past and current sun exposure, fatigue, and nutritional status. We plan the following specific aims:
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
- •(a) men and women (≥ 18 years of age) with a diagnosis of melanoma cancer within one year from diagnosis, (b) not meeting the guidelines for physical activity (less than 150 minutes of moderate intensity activity or 75 minutes of vigorous intensity activity a week for 6 weeks prior the enrollment) (c) a commitment to two weekly supervised exercise sessions or bi-monthly educational sessions for three months at University of Miami Miller School of Medicine (d) and able to understand, read and write English.
排除标准
- •(a) participants for whom physical activity is contraindicated because of comorbid conditions, (b) participants with dementia, altered mental status or psychiatric condition and (c) participants who are unwilling or unable to provide informed consent.
研究组 & 干预措施
Exercise Intervention
Subjects in the exercise group will participate in a 3-month exercise program at the University of Miami UHealth Fitness and Wellness Center. Participants will complete two exercise sessions a week, each 45-60 minutes long and on a one-on-one basis.
In addition to two site visits, the participants will receive a tailored daily home-based walking plan. The participants will use physical activity trackers (Fitbit®), with an ultimate goal of achieving 10,000 steps by the end of the intervention.
Participants in the exercise intervention will complete 24 sessions.
干预措施: Exercise Intervention (Behavioral)
Wellness Intervention
For 3 months, the wellness education group will not be offered any form of supervised exercise program or receive any specific instructions on physical activity as part of the study. The participants in this group will attend educational sessions about different wellness topics, such as nutrition, sleep, weight management, mindfulness, and the overall benefits of increased physical activity. The wellness visits will be held two times per month, and similar to the exercise sessions of the intervention arm, they will be 45-60 minutes long and on a one-on-one basis. Participants in the wellness education group will complete 6 sessions.
干预措施: Wellness Intervention (Behavioral)
结局指标
主要结局
Adherence Assessment
时间窗: 12 weeks
80% or higher of the exercise sessions completed
Feasibility Assessment
时间窗: 12 weeks
Less than 20% attrition rate for the intervention group
次要结局
- FACT-M (Functional Assessment of Cancer Therapy - Melanoma)(6 and 12 weeks)
- 6-minute Walk Test(12 weeks)
- Hand Grip(12 weeks)
- 30-sec Chair Stand(12 weeks)
- Food Frequency Questionnaire(12 weeks)
- SEBI (Sun Exposure and Behavior Inventory)(12 weeks)
- FACIT (Functional Assessment of Chronic Illness Therapy(6 and 12 weeks)
研究者
Eduard Tiozzo, PhD
Instructor
University of Miami