Resistance Training to Improve Fatigue and Physical Function in Postmenopausal Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in fatigue assessed by Multidimensional Fatigue Inventory (MFI) score
研究概览
简要总结
This study will begin to fill a knowledge gap by determine whether changes in kynurenine metabolism occur following Resistance Training (RT) and relate to reductions in inflammation and improved behavioral and physical function as this may identify potential targets for interventions to promote cancer recovery.
详细描述
Interventions that reduce pro-inflammatory cytokines with resultant stimulation of kynurenine metabolism may be increasingly important in Breast Cancer Survivors (BCS) to prevent susceptibility to cancer associated fatigue, depression, and declines in muscle mass and function.
There is emerging evidence that supports exercise as a non-pharmacological therapy to prevent cancer recurrence, sedentary behaviors, and obesity during cancer survivorship . It seems that interventions that include resistance training (RT) are most efficacious at reducing fatigue in BCS This study will begin to fill a knowledge gap by determine whether changes in kynurenine metabolism occur following RT and relate to reductions in inflammation and improved behavioral and physical function as this may identify potential targets for interventions to promote cancer recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •within 6 months to 10 years post active breast cancer therapy (i.e. surgery/chemotherapy) for stage I-III invasive breast cancer,
- •at least 6 months post breast reconstruction (if applicable),
- •lack of menses for at least one year,
- •BMI 20-35 kg/m2,
- •fatigued (subjective reporting ≥3 on a 1-10 scale),
- •untrained with regard to structured resistance training (no more than 3x/week).
排除标准
- •plans for surgery (e.g., breast reconstruction) during the study period,
- •taking an anticoagulant medication (i.e. heparin, apixaban, rivaroxaban),
- •allergic to lidocaine,
- •orthopedic or chronic pain condition restricting exercise,
- •Mini-Mental Status Examination (MMSE) scores below education-specific cut-points (less than 23 for more than 9th grade education and less than 17 for less than 8th grade education),
- •unable to receive physician medical clearance.
研究组 & 干预措施
Resistance training
干预措施: Resistance training (RT) (Other)
Cognitively-based compassion training
干预措施: Cognitively-based compassion training control (CBCT) (Behavioral)
结局指标
主要结局
Change in fatigue assessed by Multidimensional Fatigue Inventory (MFI) score
时间窗: Baseline, 12 weeks follow up
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each scale contains four items for which the person had to indicate on a seven-point scale to what extent the particular statement applies to him or her. An equal number of items is worded in a positive and in a negative direction to counteract response tendencies.
次要结局
- Change in balance test score(Baseline, 12 weeks follow up)
- Change in 6 min walk distance(Baseline, 12 weeks follow up)
- Change in depression assessed by Hamilton Depression Rating Scale (HAM-D) score(Baseline, 12 weeks follow up)
- Change in muscle function assessed by Lower Extremity Strength test(Baseline, 12 weeks follow up)
- Change in Resting Metabolic Rate (RMR)(Baseline, 12 weeks follow up)
- Change in tumor necrosis factor-α (TNF-α) protein level(Baseline, 12 weeks follow up)
- Change in muscle function assessed by Isometric Handgrip test.(Baseline, 12 weeks follow up)
- Change in Timed Up and Go (TUG) completion time(Baseline, 12 weeks follow up)
- Change in Functional Gait Assessment score(Baseline, 12 weeks follow up)
- Change in peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) level(Baseline, 12 weeks follow up)
- Change in muscle function assessed by Lower Extremity Endurance test(Baseline, 12 weeks follow up)
- Change in 30 meter walk velocity(Baseline, 12 weeks follow up)
- Change in kynurenic acid level(Baseline, 12 weeks follow up)
- Change in interleukin-6 (IL-6) level(Baseline, 12 weeks follow up)
研究者
Joe Nocera
Assistant Professor
Emory University