Effect of Low-intensity Versus Moderate-intensity Endurance Exercise on Physical Functioning Among Breast Cancer Survivors: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Change in Quality of Life
研究概览
简要总结
The purpose of this study is to evaluate the effect of two exercise programs: 1) one program will be at low intensity; 2) the other program will be at moderate intensity. One hundred forty two women who are breast cancer survivors will be recruited. Participants will be educated on a home exercise program to be performed at either low or moderate intensity, according to group assignment. Evaluations to participants will consist of function and quality of life.
详细描述
Improvements in early diagnosis and treatment for breast cancer in women have resulted in increased survivorship. An unintended consequence of increased survival, however, is that more women are living with the negative sequelae associated with cancer treatment, including decreased physical function. Exercise has been beneficial in arresting these sequelae, but adherence to exercise guidelines continues to be a challenge. As most breast cancer survivors are middle-aged and older, an alternative to enhance exercise engagement and adherence might be providing a low intensity exercise program. The overall purpose of this study is to assess the impact of a low intensity versus moderate intensity endurance exercise program on physical functioning on breast cancer survivors. It is hypothesized that participants of the low intensity exercise program will demonstrate similar physical functioning as participants in the moderate intensity exercise program. The Theory of Planned Behavior will serve as framework for the intervention. A convenience sample of 142 women, residents of Puerto Rico, age 50 or older, with a diagnosis of breast cancer, stage 0 thru III, who have received surgical treatment for breast cancer, with or without adjuvant therapy, will be randomly assigned to a low intensity or moderate intensity endurance intervention. Both interventions will be home-based, have a duration of 6 months, and be provided by physical therapists. An evaluator blinded to group assignment will assess participants at baseline and at completion of the intervention. Primary outcome measures will consist of physical functioning, and health-related quality of life.
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)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Fifty years of age or older
- •Be a resident of the San Juan metropolitan area of Puerto Rico (PR)
- •Diagnosed with breast cancer
- •Be classified in breast cancer stage grouping 0 to III according to the American Joint Committee on Cancer Classification of Malignant Tumors (TNM) Staging System (2013)
- •Have completed adjuvant curative therapy at least two months to 5 years prior to recruitment
排除标准
- •Women who have contraindications to exercise, such as extreme fatigue or anemia, unstable cardiac disease; uncontrolled diabetes; uncontrolled hypertension; coagulopathies; inability to ambulate independently
- •Women with metastasis or secondary cancers
- •Women who already meet the national standard for exercise (≥ 150 minutes per week of moderate exercise).
结局指标
主要结局
Change in Quality of Life
时间窗: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0/1.1 General Health. The Spanish version (Salud general) will be used. It contains two subdomains: Global Physical Health and Global Mental Health. The final score can be converted to a score for the EUROQoL.
Change in Functioning
时间窗: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
PROMIS Item Bank v. 1.2 Physical Function. The Spanish version (Capacidad de Funcionamiento Físico - Cuestionario Abreviado 20) will be used. It consists of 20 items, measuring upper extremity function, as well as gross motor function such as walking and stairs use.
Change in Body Image
时间窗: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
Body Appreciation Scale-2 (BAS-2; Tylka \& Wood-Barcalow, 2014), Spanish version will be used to measure body appreciation, an aspect that encompasses positive self-evaluation of body image. It has 13 items with responses ranging from 1 (never) to 5 (always). The Spanish BAS showed adequate internal consistency (Cronbach's α = .91) and construct validity (correlations with BMI, influence of the body shape model, perceived stress, coping strategies, self-esteem and variables from the Eating Disorders Inventory-2). Test-retest reliability ranged from .88 to .90.
Change in Cardiovascular fitness: Six-minute walk test
时间窗: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
Will be used to assess physical function in cancer survivors. It has been validated to assess exercise tolerance (American Thoracic Society, 2002) and has been recommended as a test suitable for fitness, as it is highly correlated with oxygen uptake. An increase in walking distance indicates an improvement in performance. Data will be collected on distance walked (meters), number of rests, and duration of rest during the 6 minutes. Rating of perceived exertion will be monitored. Heart rate and oxygen saturation will be examined using a pulse oximeter.
Change in Depression
时间窗: At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.
Inventario -II de depresión de Beck (BDI-II). The Spanish version has proper psychometric properties for assessment of depression (internal consistency, obtaining a Cronbach alfa of 0.89 and has reported known-group validity; Vega-Dienstmaier, 2014).
次要结局
- Adherence(At 6-month follow up.)
- Change in Physical Activity(At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.)
- Change in Time spend in Habitual Physical Activities(At month 1 prior to intervention (pre-test); at 6-month (post-test); 6-month follow up.)