An Exercise Facilitator to Break Down the Barriers to Physical Activity of End-stage Kidney Disease Patients. A Pragmatic Implementation Trial in a Nephrology Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- 6-minute walking test (Mobility)
研究概览
简要总结
Low physical activity levels and progressive poor functional capacity affect quality of life and clinical outcomes of Chronic Kidney Disease (CKD) patients. Interventions to prevent the functional decline associated with a sedentary lifestyle or to relief from deconditioning are crucial, considering the significant beneficial effects of exercise in all CKD patients, especially in End-stage Kidney Disease patients (ESKD). Unfortunately, physical and psychological barriers to exercise are present and physical activity management is not routinely addressed in the patient's care.
For the first time the project aims to test the impact of the regular presence of an exercise specialist in the Nephrology Unit.
This facilitator, evaluating capacity, motivation and preferences of each patient, will design tailored solutions and assess the related outcomes. Several design of training programs will be proposed to dialysis patients, that can choose the exercise option that best fits their needing.
The study will determine the feasibility of the project, the patients' adherence and the effectiveness of the programs proposed to improve the patients' lifestyle.
详细描述
The assumption underlying the project is that a wider participation to physical activity programs (PAPs) of ESKD patients may be facilitated by the presence in the Renal Unit of an exercise specialist able to design tailored programs and that this intervention may lead to measurable benefits on physical fitness, quality of life and general health.
The possible different solutions offered by an expert of exercise in chronic diseases might reduce most of the barriers to exercise responsible of the sedentary behavior of the ESKD patients. Aim of the project is to test the impact of the regular presence of this facilitator in a Nephrology Unit in terms of applicability and feasibility as well to identify the preferred and the most effective pathways for the patients.
The identification of a novel cost-effective intervention may represent an important step to manage the change of lifestyle of ESKD patients, to slow down their physical and QoL decline and to reduce hospitalizations and negative outcomes affecting this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome measures assessors will be blinded to group allocation
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
- •male and females aged > 18 years;
- •ability to walk assisted or unassisted at least for 6 meters;
- •cognitive functioning to give informed consent identified by a Mini Mental Status Examination score ≥18/30.
排除标准
- •severe cardio-respiratory (e.g. unstable angina; severe heart failure identified by New York Heart Association class III or IV);
- •neurological or musculoskeletal conditions (e.g. above knee amputation) contraindicating or inhibiting exercise training.
结局指标
主要结局
6-minute walking test (Mobility)
时间窗: Change at 3-month (end of training) respect to baseline
Subjects will be instructed to walk as far as possible on a 22m walkway in 6 minutes, with their habitual walking device, with the possibility to slow down and rest if necessary. The total distance walked, the pain-free walking distance, and the perceived exertion at the end of the test will be recorded.
次要结局
- Short Falls Efficacy Scale (sFES) (fear of falling)(Change at 3-month (end of training) respect to baseline)
- Duke Activity Status Index (DASI) (Estimated functional capacity)(Change at 3-month (end of training) respect to baseline)
- Number and rate of hospitalizations(6-month and 12-month (follow up))
- Rate of selection of different exercise program proposed (qualitative outcome)(Baseline)
- 10-meter walking test (gait speed)(Change at 3-month (end of training) respect to baseline)
- Short Form Health Survey (SF-36) (health-related quality of life)(Change at 3-month (end of training) respect to baseline)
- 6-minute walking test (Mobility)(Change at 6-month (follow-up) respect to baseline)
- Beck Depression Inventory - II (BDI-II)(Change at 3-month (end of training) respect to baseline)
- Rate of training sessions completed(3-month (end of program))
- Number and rate of mortality(6-month and 12-month (follow up))
- 5-time sit-to-stand test (lower limbs strength)(Change at 3-month (end of training) respect to baseline)
- Rate of participation (qualitative outcome)(Baseline)