Adapted Physical Activity (APA), Insulin Resistance, Oxidative Stress and Microcirculatory Haemodynamics in Breast Cancer Patients.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in BMI
研究概览
简要总结
The aim of this study is to investigate the effect of a 6-months program of Adapted Physical Activity (APA) on lifestyle, physical activity levels, insulin resistance and adipokines, oxidative stress, microcirculatory haemodynamics and serum levels of specific circulating miRNA in post-menopausal, physically inactive breast cancer patients in oncologic follow-up with or without hormone therapy that had completed adjuvant treatment (radiotherapy and/or chemotherapy) .
Furthermore, the study will determine the impact of APA on functional capabilities, on self-reported physical activity, quality of life and psychic health.
详细描述
This is a randomized controlled double-group assignment study with intermedial switch-over including post-menopausal, physically inactive breast cancer patients in oncological follow-up with or without hormone therapy, that had completed adjuvant post-surgical treatment (radiotherapy and/or chemotherapy) from at least 3 months and from not more than 3 years.
Patients in hormonal therapy and patient not in hormonal therapy will be assigned in two different groups, each one of 50 patients. In each groups, patients will be randomized divided in a control group (25 pt) and in a 6 months-physical training group (25 pt). After 6-months patient in control group will be switched in the physical training group.
The duration of the study is 2 year. Clinical evaluation of the patients will be made: at the enrollment, after 6, 12, and 24 months.
Physical activity will be adapted according to arm and shoulder morbidity, after fracture risk assessment. Exercise will be concentrated solely on leg muscles (pedalling on a cycle or bed ergometer) in individuals with limitations in the range of motion of the arms (eg, due to breast, axillary, or thoracic surgery). In patients experiencing ataxia, dizziness, or peripheral neuropathy, walking outdoors and mostly cycle-ergometry training will be preferred to other activities that also involve large muscle groups but require additional balance and coordination (eg, treadmill walking, outdoor cycling).
Exercises will be performed at the Unipolar Spinal Unit of "S. Maria della Misericordia" Hospital, Perugia.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast cancer patients in oncological follow-up
- •post-menopausal age
- •physically inactivity (light to moderate or vigorous leisure-time physical activity less than 10 minutes a day, US National Health Interview Survey)
- •assuming or not hormone therapy
- •after 3 months - 3 years from adjuvant post-surgical treatment (radiotherapy and/or chemotherapy)
排除标准
- •Patients older than 80 years
- •Inability to carry on physical activity
- •Metastatic neoplasia or unknown stage and/or histology
- •Concomitant neoplasia
- •Patients on corticosteroid treatment
- •Known heart disease (heart failure NYHA II (New York Heart Association II) or superior, angina pectoris or positive exercise stress test, treatment-related cardiotoxicity)
- •Currently on a weight loss plan or on moderate physical activity before the start of the project (no more than three sessions a week)
- •Severe cachexia (loss of more than of 35% premorbid weight or weight loss more than 10% in the last 6 months).
- •Morbidly obesity (BMI >40 kg/m2),
- •Immunodepression (absolute neutrophils count < 500/mmc)
- •Uncontrolled pain or new onset bone pain until further diagnostic study
- •Severe anemia (haemoglobin below 8 g/dL) or platelet count lower than <50000/μL
- •Fever (temperature above 38ºC) or acute infections
- •Severe nausea and vomiting within previous 24-36 h
- •Uncontrolled blood pressure (systolic blood pressure > 160 mm Hg and/or diastolic blood pressure >99 mm Hg)
结局指标
主要结局
Change in BMI
时间窗: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Reduction of BMI expressed as body mass (kg) / height\^2 (m\^2)
Change in physical activity levels
时间窗: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Self reported physical activity, using IPAQ-SF (International Physical Activity Questionnairev - Short Form) score
次要结局
- Serum adiponectin(Evaluation baseline and after 6, 12 and 24 months from enrollment.)
- Change in Post-Occlusive Reactive Hyperemia (PORH)(Evaluation baseline and after 6, 12 and 24 months from enrollment.)
- Serum IGF-1(Evaluation baseline and after 6, 12 and 24 months from enrollment.)
- VFA (Visceral Fat Area)(Evaluation baseline and after 6, 12 and 24 months from enrollment.)
- Carotid intima-media thickness (IMT)(Evaluation baseline and after 6, 12 and 24 months from enrollment.)
- Arterial stiffness(Evaluation baseline and after 6, 12 and 24 months from enrollment.)
- HOMA-IR index(Evaluation baseline and after 6, 12 and 24 months from enrollment.)
- Maximal aerobic capacity (VO2max)(Evaluation baseline and after 6, 12 and 24 months from enrollment.)
- miRNA(Evaluation baseline and after 6, 12 and 24 months from enrollment.)
- Hemorheological profile(Evaluation baseline and after 6, 12 and 24 months from enrollment.)
研究者
Ettore Marini
Resident in Internal Medicine
University Of Perugia