Contribution of Physical Activity Per Dialytic in Chronic Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in the quality of life of patients
研究概览
简要总结
Dialysis patients have reduced walking capacity and an important risk of high blood pressure. These complications are associated with a decline in quality of life and increased mortality. The hypothesis of the study is to show that physical activity during the dialysis session in dialyzed patients has a benefit on quality of life, as well as on muscle, cardiovascular and dialysis parameters.
详细描述
Dialysis patients have reduced aerobic capacity, walking ability, and an increased risk of hypertension. These complications are associated with a decline in quality of life and increased mortality.
Since asthenia is too intense after the dialysis session, patients are encouraged to perform physical activity during dialysis sessions. Some studies have shown that physical activity during dialysis can have benefits on quality of life and improve muscle parameters, but without this being clinically significant. Other studies show no benefit. The objective of the study is to explore the benefits of physical activity on quality of life, muscle parameters, and biological and dialysis parameters in a cohort of compliant hemodialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adults aged 18 and over, undergoing chronic hemodialysis at CHI André Grégoire for more than 3 months.
- •Consent to participate in physical activity during dialysis sessions.
- •Written informed consent.
- •Affiliation with a social security system
排除标准
- •Lower limb amputation without a prosthesis.
- •Non-healed foot wounds.
- •Hemoglobin < 8 g/dl.
- •Patient refusal to participate.
- •Severe respiratory (oxygen dependence) or cardiac disease (NYHA class 3 or 4, LVEF < 30%).
- •Advanced dementia or psychiatric illness impeding cooperation, or refusal to consent.
- •Non-French speaking patients unable to understand the study.
- •Patients under guardianship.
- •Advanced osteoarthritis, recent hip or knee prosthesis (< 3 months).
- •Hypotension (BP < 90/40 mmHg) or hypertension (BP > 180/110 mmHg).
- •Fever (temperature >= 38°C).
- •Hypoglycemia (fingerstick glucose < 0.8 g/l) in diabetic patients.
- •Dyspnea or desaturation in ambient air < 95%.
- •COVID-19 symptoms within the last 21 days, positive PCR test, unable to pedal.
- •Chest pain or unstable angina.
- •Muscle or joint contraindications to the pedal exerciser as assessed by a physiotherapist
结局指标
主要结局
Change in the quality of life of patients
时间窗: 17 weeks
Score of the Short Form-36 (SF36) questionnaire. The SF36 score varies from 0 to 100. A low score reflects a perception of poor health, loss of function, and presence of pain. A high score reflects a perception of good health, an absence of functional deficit and pain.
次要结局
- Change in blood pressure(17 weeks)
- Change in heart rate(17 weeks)
- Change in muscle parameters(17 weeks)
- Change in nutritional parameters(17 weeks)
- Change in glycemic control(17 weeks)
- Change in dialysis parameters (KT/V= clearance time/volume)(17 weeks)
- Change in inflammatory parameters(17 weeks)
- Change in lipid profile(17 weeks)