Effects of dance-based multimodal exercise programme for managing chemotherapy-induced peripheral neuropathy in patients with colorectal cancer: A randomized controlled study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 试验地点
- 1
- 主要终点
- Chemotherapy-induced peripheral neuropathy 5:19 PM
研究概览
简要总结
To examine the effects of a dance-based multimodal exercise programme when compared to usual care for the management of CIPN in CRC patients across the 3-month post-intervention period. The objectives include (1) To examine the effects of the programme on CIPN (primary outcome) at immediately, one-month and three-month post-intervention; and (2) To examine the effects of the programme on pain, balance, quality of life and anxiety (secondary outcomes) at immediately, one-month and three-month post intervention; and (3) To examine the effects of the programme on knowledge, motivation and self-efficacy of exercise (process outcomes) at immediately, one-month and three-month post intervention; and (4) To assess any adverse effects of the programme; and (5) To explore the perceived benefits, barriers and areas for improvement after participating the programme.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- An independent assessor will be blinded for the allocation of the participants and intervention.
入排标准
- 性别
- All
入选标准
- •The inclusion criteria of participants include CRC patients who (1) have received or currently receiving more than one cycle of oxaliplatin-based chemotherapy; and (2) experience CIPN symptoms; and (3) are able to use smart phone and WhatsApp; and (4) are able to read or understand Chinese.
排除标准
- •CRC patients will be excluded from this study when they (1) received neurotoxic chemotherapy other than oxaliplatin, including taxane-based chemotherapy, vinca alkaloids, proteasome inhibitors and thalidomide analogs; or (2) suffer from severe organ failure or diseases that limit their level of activity; or (3) are diagnosed with non-chemotherapy induced peripheral neuropathy, such as sciatica and diabetic neuropathy; or (4) receive treatments that affect the severity of neuropathy, such as steroid, anticonvulsants and antidepressants; or (5) age below 18 years old; or (6) have cognitive impairments.
研究组 & 干预措施
Dance-based multimodal exercise programme
Control group
结局指标
主要结局
Chemotherapy-induced peripheral neuropathy 5:19 PM
时间窗: Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)
次要结局
- Pain(Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention))
- Quality of Life(Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention))
- Anxiety(Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention))
- Balance(Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention))
- Knowledge of exercise, exercise motivation and exercise self-efficacy(Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention))
- Process evaluation(18th week (3-month post intervention))
- Adverse effects(6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention))