Physical Activity in Dialysis: Clinical and Biological Impact
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- The clinical impact of a physical activity program on the walking capacity.
研究概览
简要总结
Physical inactivity is known to increase the risk of developing many diseases as cardiovascular diseases, diabetes, some cancers, and other chronic diseases.
The impact of the inactivity is even higher in a fragile population as patients with Chronic Renal Failure (CRF) who need dialysis. This can lead to serious adverse events during the lifetime of these patients, such as arteriopathy which can result in amputation, deterioration of general condition, loss of independence and depression of wasting away.
Despite the need to promote physical activity in this population of hemodialysis patients with CRF, little is known about the effects of a supervised physical activity conducted in these patients.
With this study, the investigators propose to assess the effects of a physical activity program on several parameters, in hemodialysis subjects.
详细描述
The health risk of a sedentary and inactive lifestyle is known in the general population, increasing the risk of diabetes (+ 25%), obesity, arterial hypertension, stroke, myocardial infarction and the development of certain cancers.
Sedentary lifestyle therefore decreases longevity and life expectancy by 5 and 8 years respectively.
At the same time, the benefits of physical activity (PA) are recognized (the list is not exhaustive):
- Factor for improving physical capacity,
- Preventive effect on many cardiovascular risk factors,
- Improvement of psychological well-being (anxiety, depression, stress, etc.),
- Cognitive functions, reduction in the rate of certain cancers (colon and breast mainly),
- Reduction of oxidative stress. The High Authority of Health (HAS) recognizes physical activity as a therapy on its own in the prevention of chronic diseases after having noticed the harmful effects of physical inactivity (PI) on life expectancy.
PI is believed to be responsible for 1.9 million deaths worldwide each year, increasing public health costs, estimated at 150-300 euros per year and per citizen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Male or female aged 18 or over.
- •Patient on hemodialysis.
- •Patient in sufficient clinical condition allowing performing physical activity sessions during dialysis, according to the judgment of the investigator.
- •Patient who was informed of the study and who gave his informed consent.
- •Patient benefiting from a mandatory social security.
排除标准
- •Recent myocardial infarction (<1 month).
- •Rheumatological pathology which does not allow pedaling.
- •Unmatched amputation of the lower limbs.
- •Patients under legal protection.
- •Pregnant or breastfeeding women.
结局指标
主要结局
The clinical impact of a physical activity program on the walking capacity.
时间窗: 6 months after the inclusion.
Measure and evolution of the performance to the 6 minutes walking test.
次要结局
- To assess the impact on a physical activity program on the biological parameters.(At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.)
- The impact of a physical activity program on the survival.(At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.)
- The tolerance to physical activity.(1 year, during each physical activity session.)
- The clinical impact of a 12 month physical activity program on the aeroby capacity of the patients.(At the randomization visit, and 12 months after the inclusion.)
- The impact of a physical activity program on the Obstructive Arterial Disease of the Lower Limbs.(At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.)
- To assess the impact of a physical activity program on the the relationship between caregivers and patients, the creation of social ties and "coping" (the ability to cope and adapt in response to stress)(At the randomization visit, and 6 months after the inclusion.)
- To assess the impact of a physical activity program on the quality of life.(At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.)
- The clinical impact of a physical activity program on the muscle binding.(At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.)
- The impact of a physical activity program on the nutritional status.(At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.)
- The impact on a physical activity program on the biological parameters.(At the randomization visit, 6 months after the inclusion and 12 months after the inclusion.)
- The compliance with physical activity.(After each physical activity session performed by the patient.)