A Pilot Study: The Effect of Longitudinal Exercise Programming in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Lean mass
研究概览
简要总结
The investigators are doing this study to determine if there are body composition changes after a 12-week exercise program in breast cancer patients and determine what factors contribute to sustained physical activity after the 12-week exercise program intervention.
详细描述
The study is enrolling breast cancer patients up to 2 years after their diagnosis in a 12-week exercise program. The participants will either participate in: Group 1-participating in an exercise program with biometric evaluations or Group 2-biometric evaluations but not participating in the exercise program. At the end of the 12-week exercise program, participants in Group 1 will be randomized to either: a) continuing with exercise group classes or b) continuing with exercise individual classes. Both Group 1a and 1b participants will be followed for the remainder of the year and be evaluated for continued physical activity. All Group study participants' biometrics will be assessed at baseline and at the end of 12-weeks, with continued annual medical review follow-up for a total of 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •New diagnosis of breast cancer (within the past 2 years, any subtype, stage I-III)
- •Can be undergoing neo/adjuvant treatment (surgery, chemotherapy, radiation or endocrine therapy)
- •Participant is willing and able to comply with the protocol for the duration of the study including undergoing scheduled exercise sessions, completing questionnaires and biometric/biomarker studies
- •Participant must be able to lie flat on their back for up to 10 minutes
- •Participant must be able to stand without aid for at least 2 minutes
排除标准
- •Participant with breast cancer recurrence
- •Metastatic breast cancer
- •Uncontrolled psychiatric disorder that can affect self-assessment
- •Pregnant patient
- •Participants with any internal artifact (e.g. pacemakers, internal fixation, arthroplasty) or other physical impairment that would alter the body composition assessment
结局指标
主要结局
Lean mass
时间窗: 1 day
Measure lean mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Bone mass
时间窗: 1 day
Measure bone mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Waist to Hip ratio (WHR) from manual tape measurement
时间窗: 1 day
Manual physical anthropometry of waist and hip circumferences
Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
时间窗: 1 day
Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
Muscle Function
时间窗: 1 day
Measure the peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
Automatic 3D optical (3DO) scan measurement: volume measurement
时间窗: 1 day
Automated 3DO measurements generate the following: volume in cm measurements across the whole body
Automatic 3D optical (3DO) scan measurement: girth measurement
时间窗: 1 day
Automated 3DO measurements generate the following: girth in cm measurements across the whole body
Fat mass
时间窗: 1 day
Measure fat mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Isometric peak torque
时间窗: 1 day
Measure the peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
Percent fat
时间窗: 1 day
Percent fat (arms, legs, trunk and total) using Dual energy X-ray absorptiometry (DXA) data
Automatic 3D optical (3DO) scan measurement: length measurement
时间窗: 1 day
Automated 3DO measurements generate the following: length in cm measurements across the whole body
次要结局
- Recurrence Free Survival(5 years)
- Biomarkers(5 years)
- BIBCQ-Body Image After Breast Cancer questionnaire(5 years)
- BFI-Brief Fatigue Innovatory questionnaire(5 years)
- PHQ-9- Patient Health (Depression) questionnaire(5 years)
- Diet History Questionnaire II(5 years)
- FACT-G-Functional Assessment of Cancer Therapy-General (Comorbidities)questionnaire(5 years)