NCT02656927已完成不适用
Evaluation of a Specialized Yoga Program for Persons With Spinal Cord Injury: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Acceptance and Action Questionnaire-II (AAQ-II)
研究概览
简要总结
The purpose of this randomized controlled study is to evaluate psychological variables, mindfulness, and pain in the context of a specialized yoga program for individuals with SCI. Participants will be randomized to either a wait-list control condition or to a specialized yoga program condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have an SCI or a spinal related condition,
- •be 18 years of age or older,
- •be able to speak and read English,
- •commit to two weekly, one hour yoga classes for six weeks,
- •be referred from a clinician on the inter-disciplinary team,
- •have a sitting tolerance of one hour,
- •be able to participate in gentle physical activity in that time,
- •be aware of and understand his/her health contraindications (is able to practice safely),
- •provide a note from their physician indicating that it is safe for them to participate in a physical activity intervention, such as yoga.
排除标准
- •are not medically stable,
- •have pre-existing medical contraindications,
- •have cognitive limitations or language comprehension issues that would impact participation (determined by care team),
- •have had a regular yoga practice in the last six months.
研究组 & 干预措施
Yoga Condition
Experimental
干预措施: Yoga Condition (Behavioral)
Wait-list Control Condition
Placebo Comparator
干预措施: Yoga Condition (Behavioral)
结局指标
主要结局
Acceptance and Action Questionnaire-II (AAQ-II)
时间窗: Change from Baseline, 6 weeks, 12 weeks
次要结局
- General Self-Efficacy Scale (GSES)(Change from Baseline, 6 weeks, 12 weeks)
- Hospital Anxiety and Depression Scale (HADS)(Change from Baseline, 6 weeks, 12 weeks)
- Connor-Davidson Resilience Scale-10 Item (CS-RISC-10)(Change from Baseline, 6 weeks, 12 weeks)
- Five Facet Mindfulness Questionnaire-SF (FFMQ-SF)(Change from Baseline, 6 weeks, 12 weeks)
- Self-Compassion Scale-SF (SCS-SF)(Change from Baseline, 6 weeks, 12 weeks)
- Brief Pain Inventory-SF (BPI-SF)(Change from Baseline, 6 weeks, 12 weeks)
- Pain Catastrophizing Scale (PCS)(Change from Baseline, 6 weeks, 12 weeks)
- Post-Traumatic Growth Inventory-SF (PTGI-SF)(Change from Baseline, 6 weeks, 12 weeks)
研究者
Sander Hitzig
Affiliate Scientist
University Health Network, Toronto
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