NCT00483275撤回4 期
Effects of a Multi-modal 12-month-intervention With Alfacalcidol Plus Calcium, Patient Education and a Mobility Program on the Number of Fallers Among Patients With an Impaired Kidney Function Aged 65 and Older.
Ruhr University of Bochum2 个研究点 分布在 1 个国家目标入组 484 人开始时间: 2007年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 484
- 试验地点
- 2
- 主要终点
- Number of fallers
研究概览
简要总结
Objective of the study is to evaluate the effect of a multimodal therapy on the basis of current guidelines on fall prevention consisting of a 12-months intervention with Alfacalcidol and calcium, patient education and a mobility program in a group of patients 65 years of age or older with an impaired renal function in comparison to a group receiving usual care.
详细描述
The risk of falling increases with age. An impaired renal function is an additional risk factor. Guidelines and systematic reviews suggest, that multimodal interventions are most likely to control this risk. This study evaluates, if patients at high risk for falls will benefit from a multimodal intervention simple and feasible enough to be transferred into general practice. Participants will be randomized either into an intervention group or a control group receiving usual care.
The multimodal intervention consists of:
- medication: Participants receive 1µg Alfacalcidol and 500mg Calcium daily
- mobility program: strength, balance and gait training twice a week for one hour
- patient education: a single meeting with teaching lessons on risk factors for falling and modes of fall prevention followed by an evaluation of the individual fall risk and corresponding recommendations to reduce it
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women who are 65 years of age or older
- •Personal history of at least one movement-related, non-syncopal fall, either within the past year OR earlier with additional findings of an increased fall risk during screening examination.
- •Creatinine-clearance of 30 to 60 ml/min equivalent to a moderately impaired kidney function (stage 3) according to the classification of the Kidney Disease Outcomes Quality Initiative (K/DOQI) of the National Kidney Foundation (NKF).
排除标准
- •Immobility with inability to go out and participate in training course
- •History of a fracture or of a stroke provided the event has occurred in the last 3 months
- •Presence of a physical or mental disorder that has led to a set-up or to a planned set-up for a statutory care
- •Severe dementia
- •Severe disorder of speech or comprehension
- •Disease that rules out participation during the intervention period or that would deteriorate as a result of type of intervention (e.g. absorptive hypercalciuria, nephrocalcinosis, calcium containing renal calculi or hypophosphataemia)
- •Hypersensitivity (allergy) to Alfacalcidol, groundnuts, groundnut oil or Soya
- •Vitamin-D hypersensitivity or -intoxication
- •Simultaneous intake of vitamin D and its derivatives.
- •Participation in any other clinical trial, that is still ongoing or has been completed less than 3 months prior date of intended inclusion
- •Substitution of more than 500 mg calcium per day
- •Planned medical therapy during the period of intervention that requires long-term suspension of intervention.
- •Presence of hypercapnia of over 2.6mmol/l, calcium x phosphate product of over 3.7 (mmol/l)2 and alkalosis with venous blood-pH- reading of over 7.44 (milk-alkali-syndrome, Burnett syndrome)
- •Hypercalcaemia (e.g. as a result of hyperparathyroidism, an overdose of vitamin D, paraneoplastic syndrome, osseous metastases, sarcoidosis, Boeck´s disease, osteoporosis induced by immobilisation) or hypermagnesemia according to normative values of the engaged laboratory
- •Hereditary fructose intolerance
- •Commitment into an institution
结局指标
主要结局
Number of fallers
时间窗: One year
次要结局
- Number of falls(One year)
- Number of fractures(One year)
- Performance in balance and mobility(One year)
- Fear of falling(One year)
- Rate of hypercalcaemia(One year)
研究者
研究点 (2)
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