Highlighting the Medico-economic Interest of an Adapted Physical Activity for Haemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Variation in direct and indirect medical costs
研究概览
简要总结
Chronic hemodialysis is often associated with a reduction in the quality of life of patients and a reduction in physical activity, due to the repeated frequency of sessions.
Various studies conducted in hemodialysis patients have shown the beneficial effects of physical exercise during hemodialysis sessions on reducing cardiovascular risk, the number of hospitalizations and improving quality of life. It also contributes to improved patient adherence to care.
Finally, it has been shown that exercise during the hemodialysis session is safe for the patient and does not disrupt dialysis parameters.
Nevertheless, there are no data on the medico-economic impact of such a program.
Based on the investigators' experience, the investigators have developed a specific protocol linking the different types of physical activity that have provided evidence of their efficiency and used in standard practice in the investigators' institutions. From tests and questionnaires assessing the physical abilities of patients have already validated for this population in this pathology.
The objective of this project is to show the medico-economic interest of an adapted physical activity program for hemodialysis patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patient dependent on the CPAM Haute Garonne,
- •Patient affiliated to or beneficiary of a French social security scheme,
- •Haemodialysis patient for more than 12 months and in front of benefiting/benefiting from a physical activity program,
- •Patient age ≥ at 18 years old,
- •French speaking patient.
排除标准
- •Patient with cancer, hepatitis, stage 4 arterial disease, arteritis or amputation of a limb
- •Pregnant or breastfeeding women according to article L.1121-5 of the CSP,
- •Vulnerable persons according to article L.1121-6 of the CSP,
- •Persons of full age under guardianship or curatorship or under safeguard of justice,
- •Patient unable to personally give his or her consent, or age of majority protected by law,
- •Opposition expressed to inclusion in the study.
结局指标
主要结局
Variation in direct and indirect medical costs
时间窗: through study completion, an average of 1 year
Evaluation of medical costs between the 12 months prior to the start of the adapted physical activity program and the 12 months following the start of the adapted physical activity program.
次要结局
- change in the quality of life score(baseline, at 6 months and at one year)
- change in percentage of hematocrit and saturation coefficient in %(every month, up to 12 months)
- change in body mass index, weight and height will be combined to report BMI in kg/m^2(every month, up to 12 months)
- change in rate of haemoglobin in g/dL(every month, up to 12 months)
- change in rate of ferritin in ug/L(every month, up to 12 months)
- change in rate of urea, transferrin and blood sugar in g/L(every month, up to 12 months)
- change in blood presure in mmHg(every month, up to 12 months)
- change in rate of potassium in mEq/L(every month, up to 12 months)
- change in rate of bicarbonate in mmol/L(every month, up to 12 months)
- change in rate of calcium, phosphore and C-reactiv protein in mg/L(every month, up to 12 months)
- change in physical activity evaluation score, from 0 (better) to 20 (worse)(baseline, at 6 months and at one year)