A Simple Exercise Program for Patients With End Stage Kidney Disease to Improve Strength and Quality of Life: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
This study will be conducted over a 3 year time period. This is a trial of an exercise intervention vs. standard of care in patients receiving chronic dialysis. The specific aims will be to determine feasibility of patient recruitment, adherence to the exercise program, and efficacy of the intervention on patient important outcomes.
The exercise intervention will be delivered to randomized participants for 12 months, and consist of the prescribed use of Nordic Walking poles, online resources for exercise in the home, regular use of a pedometer to monitor progress, and regular verbal encouragement to exercise (monthly) by dialysis unit staff. Both groups will receive the same standard of care co-interventions including individualized dialysis prescriptions and health-care interactions according to practices at their centre.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •All ambulatory adult patients with end stage kidney disease
- •Treatment with peritoneal dialysis or hemodialysis for greater than six months
- •Able to understand English or French
- •Abuse to use Nordic Walking poles
- •Able and willing to provide informed consent
排除标准
- •Any absolute contraindication to exercise [unstable angina, uncontrolled hypertension (systolic or diastolic blood pressure greater than 180 mmHg (millimeters of mercury) or greater than 110 mmHg, respectively), deemed not suitable for exercise by the treating physician]
- •Baseline step count greater than 8000 steps a day
- •Planned living donor kidney transplant
- •Potential for recovery of renal function
- •Patients who feel unsafe using Nordic walking poles in place of their mobility aid
- •Participation in another interventional trial that may affect the results of this study
结局指标
主要结局
Adherence
时间窗: 12 months
Two-week step counts with a pedometer will be monitored monthly in the treatment group, and at baseline, 6 and 12 months in the control group.
Recruitment Feasibility
时间窗: 30 months
The investigators will assess at each centre the number of participants receiving dialysis, approached for participation, eligible to participate and any reasons for non-participation.
次要结局
- Safety of the Exercise Program(12 months)
- Change in Living Status(12 months)
- Hand Grip Strength(12 months)
- Quality of Life using Vitality Subscale(12 months)
- Hospitalizations(12 months)
- Sleep Quality(12 months)
- Hospital Length of Stay(12 months)