Resistance Training and 1,25 (OH)2D3 Administration to Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Sniff Nasal Inspiratory Pressure (SNIP)
研究概览
简要总结
This research is intended to begin to explore the impact of inspiratory muscle resistance exercise and/or 1,25(OH)2D3 for improving respiratory muscle strength in cancer patients (subjects).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Diagnosis of cancer
- •Renal and hepatic function (creatinine </= 2 x the institutional upper limit of normal; bilirubin </= 2 x the institutional upper limit of normal)
- •No contraindication to receive either of the planned interventions of inspiratory resistance training or 1,25(OH)2D3 in the opinion of the healthcare provider
- •No difficulties with swallowing oral medications in the opinion of the enrolling physician
排除标准
- •Patient is taking calcium or Vitamin D supplements and is unwilling to stop for 8 weeks
- •Severe chronic obstructive pulmonary disease (oxygen dependent or patient self-reports unable to walk one block without difficulty)
- •Calcium or phosphorus level above the institutional upper limit of normal
研究组 & 干预措施
Training and Placebo
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks
干预措施: Inspiratory isometric resistance training (Other)
Training and Placebo
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks
干预措施: Oral Placebo (Drug)
Training and Placebo
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks
干预措施: Threshold Inspiratory Muscle Trainer (IMT) (Device)
Sham Training and Vitamin D3 Metabolite
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks
干预措施: 1,25 (OH)2 D3 (Drug)
Sham Training and Vitamin D3 Metabolite
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks
干预措施: Sham Inspiratory Isometric Resistance Training (Other)
Sham Training and Vitamin D3 Metabolite
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks
干预措施: Threshold Inspiratory Muscle Trainer (IMT) (Device)
Training and Vitamin D3 Metabolite
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks
干预措施: 1,25 (OH)2 D3 (Drug)
Training and Vitamin D3 Metabolite
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks
干预措施: Inspiratory isometric resistance training (Other)
Training and Vitamin D3 Metabolite
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks
干预措施: Threshold Inspiratory Muscle Trainer (IMT) (Device)
Sham Training and Placebo
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks
干预措施: Oral Placebo (Drug)
Sham Training and Placebo
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks
干预措施: Sham Inspiratory Isometric Resistance Training (Other)
Sham Training and Placebo
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks
干预措施: Threshold Inspiratory Muscle Trainer (IMT) (Device)
结局指标
主要结局
Sniff Nasal Inspiratory Pressure (SNIP)
时间窗: 8 weeks
SNIP is a test of maximal inspiratory muscle force exerting from the diaphram. Patients sniff forcefully through one nostril while the other is obstructed. The best of 10 measurements is recorded.
次要结局
未报告次要终点