Transcranial Direct Current Stimulation(tDCS) and Circadian Rhythm Time-Based Conventional Exercises for Fatigue, Anxiety and Depression in Breast Cancer patients undergoing chemotherapy:A Single-Blind Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- FACIT-Fatigue scale
研究概览
简要总结
This study involves breast cancer patients screened by inclusion and exclusion criteria. After obtaining written informed consent and demographic data, participants are randomly allocated by the envelope method into two groups—Group A receives active transcranial direct current stimulation (tDCS) combined with circadian rhythm time-based conventional exercises, while Group B receives sham tDCS with circadian rhythm time-based conventional exercises.
Pre-intervention and post-intervention assessments are conducted using fatigue anxiety and depression outcome measures. the FACIT-Fatigue scale the Beck Anxiety Inventory (BAI) and Beck Depression Inventory . Both tDCS and the exercise interventions are administered by trained physiotherapists. The study aims to evaluate the efficacy of combining tDCS targeting fatigue with exercise timed to circadian rhythms on fatigue, anxiety and depression in breast cancer patients undergoing chemotherapy.
The intervention time was specifically set between 8:30 and 9:30 a.m., based on recommendations from the International Commission on Illumination and the WELL Building Standard, which suggest that adequate circadian stimulation in the morning.
This design allows controlled observation of the added effect of active tDCS over sham stimulation on fatigue anxiety and depression outcomes alongside standard exercise therapy, providing evidence for integrative rehabilitation approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •diagnosed with stage I–III breast cancer, scheduled to receive adjuvant or neoadjuvant chemotherapy, received approval from a medical oncologist to participate in the trial.
排除标准
- •traumatic brain injury or concussion with residual symptoms, mobility issues that require a mobility aid or an injury/illness that would prohibit exercising, self-reported physical or cognitive condition that prevented women from participating independently.
结局指标
主要结局
FACIT-Fatigue scale
时间窗: total 4 weeks of protocol,outcome will be assessed at baseline and after 4 weeks
次要结局
- Beck Anxiety Inventory
- Beck Depression Inventory(which will be assessed at baseline and after 4 weeks)
研究者
Simran Kaur Ram Prakash Singh Rahanu
KAHER Institute of Physiotherapy