Effectiveness of Aerobic Exercises and Laughter Yoga Compared With Yoga in Anxiety and Depression Levels of Breast Cancer Survivors; a Double-blind Three Arm Clinical Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Changes in the anxiety and depression levels after twelve weeks of exercises
研究概览
简要总结
90% of breast cancer survivors experience cancer-related fatigue which decreases the physical activity. Moreover, due to the cancer treatments depression and anxiety will be happened. Previous studies showed the effect of physical activity on reduction of depression and anxiety; therefore the aim of this study is to evaluate the effectiveness of aerobic exercises and laughter yoga compared with yoga in anxiety and depression levels in breast cancer survivors.
详细描述
204 breast cancer survivors will be randomized to each of these three groups: Group 1, 12 weeks aerobic exercises; Group 2, 12 weeks of laughter yoga; and Group 3, 12 weeks of yoga.
To assess the effectiveness of these exercises in depression and anxiety levels, patients will complete the hospital anxiety and depression scale (HADS) questionnaire before and after the 3-month exercise.
For secondary outcomes, patients will complete the following questionnaires before and after the 3-month exercise: 36-item short-form survey (SF-36), Minnesota Living with Heart Failure Questionnaire (MLHFQ), Insomnia Severity Index, Beck's depression inventory-Ⅱ (BDI-Ⅱ), Chalder's chronic fatigue syndrome, and five facet mindfulness questionnaire (FFMQ).
The effectiveness of the mentioned exercises in primary and secondary outcomes will be assessed using ANOVA/ANCOVA analysis by adjusting the baseline assessment. Mean difference (MD) and standardized mean difference (SMD) with their 95% confidence interval (CI) will be reported to show the effectiveness of aerobic exercises and laughter yoga compared with yoga in different outcomes.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 20 to 65 years
- •Patients with stage Ⅰ-Ⅲ of breast cancer
- •Chemotherapy is completed at least six months before registration
- •Lack of active participation in regular exercise programs
排除标准
- •Reluctance to cooperate and enter the study
- •Do not complete the questionnaires correctly
- •Have diseases such as severe heart failure (Minnesota Living with Heart Failure Questionnaire score more than 50), severe valvular disease, coronary stenosis of the heart, and metastatic cancer
- •Feel chest pain and dizziness during the exercise
- •Patients currently receiving treatment
- •Patients who do not have the physical ability to participate in the exercise
- •Patients with mental health disorders that cannot participate in the exercise
结局指标
主要结局
Changes in the anxiety and depression levels after twelve weeks of exercises
时间窗: 0 and 3 months
Hospital anxiety and depression scale (HADS) questionnaire will be used to determine the anxiety and depression levels. This questionnaire contains 14 questions, of which seven concern anxiety and seven concern depression. Each question is scored from 0 (never) to 3 (almost always); the final score will be 0 to 52, and the higher scores indicate greater anxiety and depression.
次要结局
- Changes in the general quality of life after twelve weeks of exercises(0 and 3 months)
- Changes in the Insomnia severity after twelve weeks of exercises(0 and 3 months)
- Changes in the disease-specific quality of life after twelve weeks of exercises(0 and 3 months)
- Changes in depression after twelve weeks of exercises(0 and 3 months)
- Changes in chronic fatigue after twelve weeks of exercises(0 and 3 months)
- Changes in mindfulness after twelve weeks of exercises(0 and 3 months)
研究者
Fateme Abedini
Principal investigator
Isfahan University of Medical Sciences